Drug Development and Regulatory Affairs

so welcome friends to education tricks 99 so before going further i will introduce myself my name is sachin gakkad and i did my master of pharmacy in pharmaceutical quality assurance i also did post graduation diploma in pharmaceutical regulatory affairs and i am from delhi so coming to the course interview like sorry course overview like what we learn in this video so in this video we will learn drug development approval process like what is regulatory affairs and what are the different roles and responsibilities of the regulatory affairs professional like what are the different functions the regulatory affairs professionals would do okay and then regulatory authorities of different countries like there are different countries for uh there are different regulatory authorities for different countries like for europe there is a emea which is europe european medicine evaluation agency for us you there is a usfda so we will learn one by one and there will be the we will discuss the orange book what is orange book what is ich and what is 180 day exclusivity okay then we will learn basic terminologies like gen generic drug product ind nda a nda and then there will be potential u.s regulatory pathways like what are the different potential u.s regulatory pathway pathways and then there will be the dmf and its types and then we will learn top types of nda filing like what are the different types of nda filing then we will learn ctd and its modules then we will learn marketing authorization application like what is marketing authorization application it is basically for europe market and then we will learn active substance master file then we will learn marketing authorization procedure for pharmaceutical in europe like what is marketing authorization procedure and then we will learn procedures for drug approval in europe like how the drug is approved in europe why are different types of procedures then we will learn different betweens the nda and a nda which is new drug application and abbreviated new drug application so coming to the first topic drug development and approval process so basically the first step for the drug development is basic research and target discovery like we should know about what is our target so that we can develop our product okay and after that there will be the drug discovery then the third step is the pre-clinical testing where we can uh we can investigate our drug in in an animal study so that is preclinical testing then after the pre-clinical testing we have to submit the ind application which is investigational new drug application and this ind application is reviewed by fda which is the uh which is a regulatory authority of u.s so after this reviewing of this ind by fda if fda approved that ind so that so only then we can conduct a clinical trial so this clinical trial is basically there are different types of clinical trials like uh it is conduct on human so uh three four phases of clinical trials are there like phase one phase two phase three and phase four so phase one clinical trial is basically conducted on a healthy volunteers and it is uh basically for uh to know about the side effects and the dosage of a drug okay and then uh phase two trial is conducted on a 2200 people uh which is uh patients okay so and then it is also used to determine the efficacy of a drug product then there will be the phase three it is conducting on a larger population uh for determining the long-term efficacy of a drug product and then there will be the phase four trial which is also called as post marketing authorization it is also uh conducting for us to determine the safety and efficacy of a drug product so then after the conducting of the clinical trials we we will submit the nda submission which is new drug application submission and it is also reviewed by fda so after this reviewing by fda if the fda authorized that particular new drug application only then the uh manufacturing or marketing of drug is applicable okay if the fda uh like doesn't approve that particular nds submission so we we don't have an authority to manufacture that particular drug so this is all about the drug development process now coming to the very very important topic regulatory affairs okay see friends these these topic is very important for interview point of view okay so we you have to discuss uh you have to learn this uh terminologies and you have to understand okay like what is regulatory affair it will help you in your future also like in your career also like you will understand like what is regulatory affair like what are the different roles so that you can choose your career at a very best level right so what is regulatory affair so regulatory affair is basically in the pharmaceutical industry we can say a regulatory affairs is a profession that acts as the interface between the pharmaceutical industry and the drug regulatory authorities in the world okay so basically it acts as an interface between the pharmaceutical industry and the drug regulatory authorities in the world so it is mainly involved in the registration of a drug product before the marketing in respective countries okay so like if the drug product is registered in particular country only then the product is marketing the product will be market marketing okay then coming to roles and responsibilities of regulatory affairs professional like what are the different functions of the regulatory affairs professional like what we what they will do in that particular domain so on regulatory aspects we can say ra professional advises the company okay like they advises the company as per the guidelines and they prepare inda which is investigational new drug application nda which is new drug application a nda which is aptly abbreviated new drug application maa which is marketing authorization application dmf is drug master file so according to the guidelines they prepare and compile then ra professional also ensures adherence and com compliance with all applicable guidelines regulations such as ich cgmp which is good manufacturing current good manufacturing practices then glp which is good laboratory practices then gcp which is good clinical practices guidelines so according to these guidelines they had the ra professional ensure the adherence and compliance then there will be also they they do life cycle management of that drug product like they will also file the variations like after the post marketing so post marketing variations they will file and apart from that there are also other functions of the ra professionals so coming to the regulatory authorities of the different countries like what are the different regulatory authorities of a different different countries so for usa i already told you the united states food and drug administration for uk it is medicines and healthcare product regulatory agency which is sorry mhra then for europe it is european medicines evaluation agency which is emea for australia the regulatory authority is therapeutic goods administration which is also called as tga then brazil so brazil is for n visa okay we can see uh and visa is agencia national de vigilencia sanitaria so in china the regulatory authority is state food and drug administration uh japan ministry of health labor and welfare mhlw so these are the very important regulatory authorities so in spite of this there are other regulatory authorities also so now coming to inda what is ind so india is investigational new drug application so it is an application which is to get approval for conducting a human clinical trial so i already told you in the development drug development process like for conducting a human clinical trial we have to file i n d which is investigational new drug application and it is also uh for shipping of experimental drugs usually to clinical investigators we also have to file the ind okay and it is filed with fda which is usfd the regulatory authority of u.s and sorry so uh there are three types of ind applications right first is investigator ind the second one is treatment ind and the third one is emergency user what is investigator ind investigator ind is basically submitted by a physician like the physician initiates and conduct the investigational study of that particular experimental drug then the treatment ind treatment ind is basically filed with the fda for serious or a life-threatening condition right if there is any serious or life-threatening condition and if uh if the experimental drug is promising like for uh to use the to to use in a particular disease so uh the fda will review that ind and they will authorize fda will authorize the use of that particular ind in the serious or life threatening condition then there will be the emergency use ind so as the name suggests emergency so basically emergency use ind is basically filed with the fda in an emergency condition okay the experimental drug or or we can say the investigational drug is used in that particular emergency situation so it is also authorized by fda then coming to nda so nda is basically new drug application okay so it is an application which is filed with the fda to market a new pharmaceutical drug products for sale in the usa okay so it is a application which is filed with fda to market a new pharmaceutical drug product okay for sale in the usa so this application includes animal studies as well as human clinical trial okay so this applications uh includes animal studies as well as human clinical trials of an investigational new drug so what is generic drug product so a generic drug product is that which is comparable to the innovator drug product okay so a generic product is should be comparable to innovator drug product in terms of dosage form like it should be the same dosage form the same route of administration and quality strength performance and intended use it should be same as compared to innovator drug okay only then we can say it is a generic drug product because generic drug product is is is a copy of the innovator drug product right now coming to the potential you uh potential u.s regulatory pathways so like what are the difference different regulatory pathways so there are three pathways uh by which we can market our product like five zero five j a and d a five zero five b two a n d a and five zero five b one n d so what is five zero five j a and d a five zero five j a and d is basically for that products that are same as approved products okay i already told you amd is basically for a generic drug product okay so these application is filed with fda for the products which are similar to uh to dac products which is already approved in that particular country okay then 505b to nda so this is hybrid uh first we um sorry we will uh let you know i will let you know the five zero five b one and d a what is five zero five b one and d so five zero five b one and d a is is a full application new drug application which is the uh the data obtained from the sponsor conducted studies okay and this 505 b2 nda is a hybrid like between 505 j a nda and 505 b1 full nda okay so these are the three regulatory pathways in the us then coming to the drug master file so drug master file comes under the code of federal regulation 314.42 okay so 21cfr which is code of federal regulation so it is a submission to the fda which provides the confidentially detailed information okay so it is a submission to the fda which provides the confidentially detailed information about what about facilities like different facilities the process used for the manufacturing the packaging the storage of the drugs and the chemistry control of drug products or a component of a drug product sorry now so it is uh submitted to the fda to support ind nda a nda or another dmf or amendments and supplements to any of these and it is not required when the applicant references its own information okay please not that point so if the applicant wants to reference its own information so it is not required then known cmc information may also be filed in drug master files so see what is cmc cnc is basically the chemistry manufacturing and control then coming to different types of master drug master file so there are five types of drug master file type 1 type 2 type 3 type 4 and type 5. so we will discuss one by one the type one is basically for the manufacturing site facilities operating procedures and personals okay and it is not longer accepted by the fda then type 2 is basically for the drug substance drug substance intermediates and materials which are used in their preparation of that particular drug substance and drug substance intermediates or the drug product then type 3 is for packaging materials type 4 is for excipients flavors colorants essence or materials which are used in their preparation then type 5 is the reference information which is accepted by the fda but fda discouraged its use okay then coming to a very important topic ich so what is the full form of ich ich is basically the international council for harmonization of the technical requirements for pharmaceuticals for human use earlier it was international conference but now it is currently updated to international council so it is the international council for harmonization of technical requirements for pharmaceuticals for human use so basically why the ich is you know there for the regulations and all so it brings the bring together the three regulatory authorities of the countries like europe japan and united states and pharmaceutical industries to discuss scientific and technical aspects of that pharmaceutical product registration okay so there are four types of ich guidelines okay the number one is for quality two for safety three for efficacy and four for multi-disciplinary so in short form we can say qsem now then quality so in the quality guidelines so the it will discuss about the stability like stability of the drugs drug substance drug product then impurity testing good manufacturing practices what are the pharmaceutical development of that drug product substance okay so in in the quality guidelines we will uh like these are the parameters or the subtopics then there will be the safety guidelines so in the safety guidelines carcinogenicity genotoxicity or ripro toxicity is given in that particular guidelines uh in efficacy guidelines the clinical trials and pharmacogenomics is discussed and the various types of guidelines are there for the efficacy studies safety and qualities and multidisciplinary so in multi-disciplinary there are other sub topics like uh other guidelines for medra ctd electronic standards so this is the four types of ich guidelines now what is approved drug products with therapeutic equivalence evaluation so in my course overview i mentioned orange book so it is also called as orange book what is orange book it is approved drug product with therapeutic equivalence evaluation so it is published by us fda this book is published by usfdi and in this book there are a list of approved drug products with therapeutic equivalence evaluation so it contains a list of drug products which are approved on the basis of safety and if effectiveness or we can say efficacy by the fda under the food drug and cosmetic act okay now coming to 180 day or a nda exclusivity so 180 day or amd exclusivity is a very important topic for interview point of view so what is this like a first person to file an a nda like andea is for generic drug like abbreviated new drug application so when a first person to file a particular nda with a para 4 certification para 4 is a filing so we will discuss further what is para 1 para 2 para 3 para four filings so with the paraphore certification gets 180 day during which no other a nda filing can be approved for that drug okay so when a first person to file an a nda with a para 4 certification so so they will get 180 day exclusivity for that particular drug so in that interval no other and a person no other person can file that and df for that approved okay so it could be granted to more than one applicant now coming to the types of nda filing like what are the different types of amd filing so there are four types of filing by which we can submit our amda like para one filing para 2 para 3 and paraphore so what is para1 filing para one filing is uh when then there is a when there is a no listed patent in the orange book okay so in the orange book if there is no listed patent then we will file the para one we will file an amd by using paraben filing okay if one or more applicants so in paragon filing one or more applicants may enter and fda may approve generic immediately by paragon filing okay and then para 2 filing so it is made when the drug is already off patent so in simple word we can say the listed patent has expired so when the listed patent has expired only then we can use this para 2 filing for submit our amd for the generic drugs okay then para 3 filing so it is uh it is when then a patent when a patent will expire on the particular date like it is not expire it will be expire on particular date so a generic manufacturer manufacturer will keep away from the market until the patent expires so when the patent expire the generic manufacturer will able to file that a nda via para 3 filing okay then there will be a para four filing like what is paraphore filing when a patent is invalid okay when a patent is invalid or will not be infringed by the drug for which approval is being sought so we can file an amd okay then coming to the ctd and its modules like what is ctd and its module so ctd is a common technical document which is maintained by ich so it is a set of specifications or a guidelines for application dosier for registration of a pharmaceutical product and these specifications are designed to use across europe japan and united states okay so through ctd safety and efficacy information is assembled or compiled in a common format so through this ctd format we can compile the quality safety and efficacy information in a common format right and then ctd format is widely accepted by the regulatory authorities of other countries also like rather in u.s europe and japan is also there but in other countries also the ctd format is used like in australia and canada okay then coming to ctd modules so there are five modules of the ctd module one two three four five so module one is not a part of the ctd and which is also called as the regional administrative information so module one contains regional administrative information and module two contains the seed it is divided into different parts like in module two so like it contains ctd table of content then ctd introduction like common technical document introduction then quality overall summary and then non-clinical overviews non-clinical summary clinical overviews and clinical summaries okay so qos is quality overall summary and toc is table of content so this is module 2 and then module 3 describes the quality part module 4 is for non-clinical study reports for the safety purpose and module 5 represents the clinical study reports which is for the efficacy studies okay so this is the ctd module complete cdd module now coming to marketing authorization application so it is basically for the europe so it is an application which is filed with the regulatory body of europe and look for permission to bring a developed pharmaceutical product to the market so for uh like it is basically filed in a regulatory body of europe for for bringing permission to develop the pharmaceutical product to the market like a developed pharmaceutical product to the market so marketing authorization application can be filed for different things like it can be filed for a product which contains new chemical compounds like or a biological api active pharmaceutical ingredients or it can also be filed for a variations to the existing marketing authorization so if a particular product is already approved in the europe country but there is some variations to that particular product so it so it so maa marketing authorization application can also be filed for that and for the generic products mma maa is also filed okay then coming to active substance master file what is active substance master file so it is similar to dmf but the com the main difference is dms dmf is submitted for us and asmf is submitted for euro so it is submitted to the drug regulatory authority of europe to provide confidential information of the api because as the name suggests active substance so it provides the confidential information about what api so it is a type of dmf and it is recognized term in the euro and it is also called as european drug master file and it can be used for the following active substance like what are the different type of active substances for which this uh you know uh the application is file in in that europe so the active substances if the active substances pharmacopoeial active substance if it is existing active substance which is not given in the european pharmacopoeia or if it is a new active substance okay so so we can file the active substance master file now coming to the marketing authorization procedure for pharmaceuticals in europe so like what how uh the product is basically going to the market so this is the procedure so firstly there is the first step is to file the marketing authorization application then there will be the rms and cms so what is rms rms is reference member state and cms is concerned member state so reference member state is selected by the applicant so whosoever wants to market a particular product so they will accordingly in a country so they will accordingly select the rms so rms is acts as a central point between member state and marketing authorization holder so it acts as a center point between marketing authorization holder and member state and it has to prepare the assessment report so rms has to prepare the assessment report so whatever the applicant filed their application so rms has to assess and let them know to cms okay so this maa the application going to rms and cms then the validation of that particular application is conducted by rms reference member state after the validation there will be the distribution of assessment report like whatever the rms assessed uh in that particular application so they will distribute the information to cms which is concerned member state so after that validation of application by cms then there will be another step validation also like the cms also validate that information of the application and if cms approves the assessment report like the assessment report by rms so if cms also approves so then marketing authorization will be given to the applicant for each cms which is concerned member state so concerned member state is all other member states where the company has submitted the dosia okay now so what are the different procedures for drug approval in europe like there are different procedures so that we can market our product in the euro so four types of drug procedure drug approval four types of procedures in the drug approval national procedure mutual recognition procedure centralized procedure and decentralized procedure now coming to one by one national procedure so the majority of the medicinal or the drug product are authorized to market in europe through this procedure okay and each european member state has its own national authorization procedures like in europe there are so many states so in each european member states has its own national authorization procedure and this national procedure is not in the scope of centralized procedure this procedure is very specific to particular national procedure okay and the assessment time like it will take two one zero days for their assessment the particular application they will assess in 210 days so for authorization of drug product in several member states like if the applicant wants to market a product in several member states so they will they will file the application by two procedures first is mrp and second is dcp so they will file by two procedures mrp or dcp so what is mutual recognition procedure so the medicinal product has already been received in a member state a market authorization at a time of application so in simple words we can say it is an application for the products are already licensed in the europe okay so when the product is already approved in that in the europe in in a different state so only then mrp will be considered so it is based on the medicinal products which are evaluated and approved by rms followed by a 90-day period where the cms consider the rms assessment report so cms is concerned member state and rms is reference member state i o as i already told you so assessment time for the mrp is 90 days plus 30 days for the national phase okay then decentralized procedure so it is to acquire the marketing authorization in several member states even though there are no marketing authorization has been granted so in mrp marketing authorization is compulsory okay so like if the if one ma is already approved like if one uh one drug product is already approved by a procedure national procedure so mrp will be considered but if there is no marketing authorization in the europe area so decentralized procedure can also be uh used for the marketing application so assessment time is 210 days plus 30 days 30 days for national phase now centralized procedure so it is only one single marketing authorization application to the european medicinal agency so it is a single marketing authorization and it is it it gives the transparent evaluation it do transparent evaluation single ma is valid in all european member states and this procedure is compulsory for most innovative medicines and for including rare diseases and the assessment time will be 210 days plus time taken by the european commission decision making process okay now coming to the last slide last topic the difference between nda and a nda so what is new drug application and abbreviated new drug application i already told you so what are the difference between this so in nda it is for application of applicable for new drug and for amd it is applicable for generic drug and nda will take longer time as compared to a nda so nda will take 12 to 15 years while a nda will take only one to two years okay so the cost of drug is more in ndf for nda and the cost of drug is less for alda so non-clinical and clinical studies are essential for nda okay but for amda these studies are not essential like non-clinical and clinical studies but bioavailability or bioequivalence studies are essential so thank you guys i hope you like the video so if you like the video please subscribe and please like please share the video please don't forget to hit the bell icon for latest notifications so thank you very much guys thank you

so welcome friends to education tricks 99 so before going further i will introduce myself my name is sachin gakkad and i did my master of pharmacy in pharmaceutical quality assurance i also did post graduation diploma in pharmaceutical regulatory affairs and i am from delhi so coming to the course interview like sorry course overview like what we learn in this video so in this video we will learn drug development approval process like what is regulatory affairs and what are the different roles and responsibilities of the regulatory affairs professional like what are the different functions the regulatory affairs professionals would do okay and then regulatory authorities of different countries like there are different countries for uh there are different regulatory authorities for different countries like for europe there is a emea which is europe european medicine evaluation agency for us you there is a usfda so we will learn one by one and there will be the we will discuss the orange book what is orange book what is ich and what is 180 day exclusivity okay then we will learn basic terminologies like gen generic drug product ind nda a nda and then there will be potential u.s regulatory pathways like what are the different potential u.s regulatory pathway pathways and then there will be the dmf and its types and then we will learn top types of nda filing like what are the different types of nda filing then we will learn ctd and its modules then we will learn marketing authorization application like what is marketing authorization application it is basically for europe market and then we will learn active substance master file then we will learn marketing authorization procedure for pharmaceutical in europe like what is marketing authorization procedure and then we will learn procedures for drug approval in europe like how the drug is approved in europe why are different types of procedures then we will learn different betweens the nda and a nda which is new drug application and abbreviated new drug application so coming to the first topic drug development and approval process so basically the first step for the drug development is basic research and target discovery like we should know about what is our target so that we can develop our product okay and after that there will be the drug discovery then the third step is the pre-clinical testing where we can uh we can investigate our drug in in an animal study so that is preclinical testing then after the pre-clinical testing we have to submit the ind application which is investigational new drug application and this ind application is reviewed by fda which is the uh which is a regulatory authority of u.s so after this reviewing of this ind by fda if fda approved that ind so that so only then we can conduct a clinical trial so this clinical trial is basically there are different types of clinical trials like uh it is conduct on human so uh three four phases of clinical trials are there like phase one phase two phase three and phase four so phase one clinical trial is basically conducted on a healthy volunteers and it is uh basically for uh to know about the side effects and the dosage of a drug okay and then uh phase two trial is conducted on a 2200 people uh which is uh patients okay so and then it is also used to determine the efficacy of a drug product then there will be the phase three it is conducting on a larger population uh for determining the long-term efficacy of a drug product and then there will be the phase four trial which is also called as post marketing authorization it is also uh conducting for us to determine the safety and efficacy of a drug product so then after the conducting of the clinical trials we we will submit the nda submission which is new drug application submission and it is also reviewed by fda so after this reviewing by fda if the fda authorized that particular new drug application only then the uh manufacturing or marketing of drug is applicable okay if the fda uh like doesn&#39;t approve that particular nds submission so we we don&#39;t have an authority to manufacture that particular drug so this is all about the drug development process now coming to the very very important topic regulatory affairs okay see friends these these topic is very important for interview point of view okay so we you have to discuss uh you have to learn this uh terminologies and you have to understand okay like what is regulatory affair it will help you in your future also like in your career also like you will understand like what is regulatory affair like what are the different roles so that you can choose your career at a very best level right so what is regulatory affair so regulatory affair is basically in the pharmaceutical industry we can say a regulatory affairs is a profession that acts as the interface between the pharmaceutical industry and the drug regulatory authorities in the world okay so basically it acts as an interface between the pharmaceutical industry and the drug regulatory authorities in the world so it is mainly involved in the registration of a drug product before the marketing in respective countries okay so like if the drug product is registered in particular country only then the product is marketing the product will be market marketing okay then coming to roles and responsibilities of regulatory affairs professional like what are the different functions of the regulatory affairs professional like what we what they will do in that particular domain so on regulatory aspects we can say ra professional advises the company okay like they advises the company as per the guidelines and they prepare inda which is investigational new drug application nda which is new drug application a nda which is aptly abbreviated new drug application maa which is marketing authorization application dmf is drug master file so according to the guidelines they prepare and compile then ra professional also ensures adherence and com compliance with all applicable guidelines regulations such as ich cgmp which is good manufacturing current good manufacturing practices then glp which is good laboratory practices then gcp which is good clinical practices guidelines so according to these guidelines they had the ra professional ensure the adherence and compliance then there will be also they they do life cycle management of that drug product like they will also file the variations like after the post marketing so post marketing variations they will file and apart from that there are also other functions of the ra professionals so coming to the regulatory authorities of the different countries like what are the different regulatory authorities of a different different countries so for usa i already told you the united states food and drug administration for uk it is medicines and healthcare product regulatory agency which is sorry mhra then for europe it is european medicines evaluation agency which is emea for australia the regulatory authority is therapeutic goods administration which is also called as tga then brazil so brazil is for n visa okay we can see uh and visa is agencia national de vigilencia sanitaria so in china the regulatory authority is state food and drug administration uh japan ministry of health labor and welfare mhlw so these are the very important regulatory authorities so in spite of this there are other regulatory authorities also so now coming to inda what is ind so india is investigational new drug application so it is an application which is to get approval for conducting a human clinical trial so i already told you in the development drug development process like for conducting a human clinical trial we have to file i n d which is investigational new drug application and it is also uh for shipping of experimental drugs usually to clinical investigators we also have to file the ind okay and it is filed with fda which is usfd the regulatory authority of u.s and sorry so uh there are three types of ind applications right first is investigator ind the second one is treatment ind and the third one is emergency user what is investigator ind investigator ind is basically submitted by a physician like the physician initiates and conduct the investigational study of that particular experimental drug then the treatment ind treatment ind is basically filed with the fda for serious or a life-threatening condition right if there is any serious or life-threatening condition and if uh if the experimental drug is promising like for uh to use the to to use in a particular disease so uh the fda will review that ind and they will authorize fda will authorize the use of that particular ind in the serious or life threatening condition then there will be the emergency use ind so as the name suggests emergency so basically emergency use ind is basically filed with the fda in an emergency condition okay the experimental drug or or we can say the investigational drug is used in that particular emergency situation so it is also authorized by fda then coming to nda so nda is basically new drug application okay so it is an application which is filed with the fda to market a new pharmaceutical drug products for sale in the usa okay so it is a application which is filed with fda to market a new pharmaceutical drug product okay for sale in the usa so this application includes animal studies as well as human clinical trial okay so this applications uh includes animal studies as well as human clinical trials of an investigational new drug so what is generic drug product so a generic drug product is that which is comparable to the innovator drug product okay so a generic product is should be comparable to innovator drug product in terms of dosage form like it should be the same dosage form the same route of administration and quality strength performance and intended use it should be same as compared to innovator drug okay only then we can say it is a generic drug product because generic drug product is is is a copy of the innovator drug product right now coming to the potential you uh potential u.s regulatory pathways so like what are the difference different regulatory pathways so there are three pathways uh by which we can market our product like five zero five j a and d a five zero five b two a n d a and five zero five b one n d so what is five zero five j a and d a five zero five j a and d is basically for that products that are same as approved products okay i already told you amd is basically for a generic drug product okay so these application is filed with fda for the products which are similar to uh to dac products which is already approved in that particular country okay then 505b to nda so this is hybrid uh first we um sorry we will uh let you know i will let you know the five zero five b one and d a what is five zero five b one and d so five zero five b one and d a is is a full application new drug application which is the uh the data obtained from the sponsor conducted studies okay and this 505 b2 nda is a hybrid like between 505 j a nda and 505 b1 full nda okay so these are the three regulatory pathways in the us then coming to the drug master file so drug master file comes under the code of federal regulation 314.42 okay so 21cfr which is code of federal regulation so it is a submission to the fda which provides the confidentially detailed information okay so it is a submission to the fda which provides the confidentially detailed information about what about facilities like different facilities the process used for the manufacturing the packaging the storage of the drugs and the chemistry control of drug products or a component of a drug product sorry now so it is uh submitted to the fda to support ind nda a nda or another dmf or amendments and supplements to any of these and it is not required when the applicant references its own information okay please not that point so if the applicant wants to reference its own information so it is not required then known cmc information may also be filed in drug master files so see what is cmc cnc is basically the chemistry manufacturing and control then coming to different types of master drug master file so there are five types of drug master file type 1 type 2 type 3 type 4 and type 5. so we will discuss one by one the type one is basically for the manufacturing site facilities operating procedures and personals okay and it is not longer accepted by the fda then type 2 is basically for the drug substance drug substance intermediates and materials which are used in their preparation of that particular drug substance and drug substance intermediates or the drug product then type 3 is for packaging materials type 4 is for excipients flavors colorants essence or materials which are used in their preparation then type 5 is the reference information which is accepted by the fda but fda discouraged its use okay then coming to a very important topic ich so what is the full form of ich ich is basically the international council for harmonization of the technical requirements for pharmaceuticals for human use earlier it was international conference but now it is currently updated to international council so it is the international council for harmonization of technical requirements for pharmaceuticals for human use so basically why the ich is you know there for the regulations and all so it brings the bring together the three regulatory authorities of the countries like europe japan and united states and pharmaceutical industries to discuss scientific and technical aspects of that pharmaceutical product registration okay so there are four types of ich guidelines okay the number one is for quality two for safety three for efficacy and four for multi-disciplinary so in short form we can say qsem now then quality so in the quality guidelines so the it will discuss about the stability like stability of the drugs drug substance drug product then impurity testing good manufacturing practices what are the pharmaceutical development of that drug product substance okay so in in the quality guidelines we will uh like these are the parameters or the subtopics then there will be the safety guidelines so in the safety guidelines carcinogenicity genotoxicity or ripro toxicity is given in that particular guidelines uh in efficacy guidelines the clinical trials and pharmacogenomics is discussed and the various types of guidelines are there for the efficacy studies safety and qualities and multidisciplinary so in multi-disciplinary there are other sub topics like uh other guidelines for medra ctd electronic standards so this is the four types of ich guidelines now what is approved drug products with therapeutic equivalence evaluation so in my course overview i mentioned orange book so it is also called as orange book what is orange book it is approved drug product with therapeutic equivalence evaluation so it is published by us fda this book is published by usfdi and in this book there are a list of approved drug products with therapeutic equivalence evaluation so it contains a list of drug products which are approved on the basis of safety and if effectiveness or we can say efficacy by the fda under the food drug and cosmetic act okay now coming to 180 day or a nda exclusivity so 180 day or amd exclusivity is a very important topic for interview point of view so what is this like a first person to file an a nda like andea is for generic drug like abbreviated new drug application so when a first person to file a particular nda with a para 4 certification para 4 is a filing so we will discuss further what is para 1 para 2 para 3 para four filings so with the paraphore certification gets 180 day during which no other a nda filing can be approved for that drug okay so when a first person to file an a nda with a para 4 certification so so they will get 180 day exclusivity for that particular drug so in that interval no other and a person no other person can file that and df for that approved okay so it could be granted to more than one applicant now coming to the types of nda filing like what are the different types of amd filing so there are four types of filing by which we can submit our amda like para one filing para 2 para 3 and paraphore so what is para1 filing para one filing is uh when then there is a when there is a no listed patent in the orange book okay so in the orange book if there is no listed patent then we will file the para one we will file an amd by using paraben filing okay if one or more applicants so in paragon filing one or more applicants may enter and fda may approve generic immediately by paragon filing okay and then para 2 filing so it is made when the drug is already off patent so in simple word we can say the listed patent has expired so when the listed patent has expired only then we can use this para 2 filing for submit our amd for the generic drugs okay then para 3 filing so it is uh it is when then a patent when a patent will expire on the particular date like it is not expire it will be expire on particular date so a generic manufacturer manufacturer will keep away from the market until the patent expires so when the patent expire the generic manufacturer will able to file that a nda via para 3 filing okay then there will be a para four filing like what is paraphore filing when a patent is invalid okay when a patent is invalid or will not be infringed by the drug for which approval is being sought so we can file an amd okay then coming to the ctd and its modules like what is ctd and its module so ctd is a common technical document which is maintained by ich so it is a set of specifications or a guidelines for application dosier for registration of a pharmaceutical product and these specifications are designed to use across europe japan and united states okay so through ctd safety and efficacy information is assembled or compiled in a common format so through this ctd format we can compile the quality safety and efficacy information in a common format right and then ctd format is widely accepted by the regulatory authorities of other countries also like rather in u.s europe and japan is also there but in other countries also the ctd format is used like in australia and canada okay then coming to ctd modules so there are five modules of the ctd module one two three four five so module one is not a part of the ctd and which is also called as the regional administrative information so module one contains regional administrative information and module two contains the seed it is divided into different parts like in module two so like it contains ctd table of content then ctd introduction like common technical document introduction then quality overall summary and then non-clinical overviews non-clinical summary clinical overviews and clinical summaries okay so qos is quality overall summary and toc is table of content so this is module 2 and then module 3 describes the quality part module 4 is for non-clinical study reports for the safety purpose and module 5 represents the clinical study reports which is for the efficacy studies okay so this is the ctd module complete cdd module now coming to marketing authorization application so it is basically for the europe so it is an application which is filed with the regulatory body of europe and look for permission to bring a developed pharmaceutical product to the market so for uh like it is basically filed in a regulatory body of europe for for bringing permission to develop the pharmaceutical product to the market like a developed pharmaceutical product to the market so marketing authorization application can be filed for different things like it can be filed for a product which contains new chemical compounds like or a biological api active pharmaceutical ingredients or it can also be filed for a variations to the existing marketing authorization so if a particular product is already approved in the europe country but there is some variations to that particular product so it so it so maa marketing authorization application can also be filed for that and for the generic products mma maa is also filed okay then coming to active substance master file what is active substance master file so it is similar to dmf but the com the main difference is dms dmf is submitted for us and asmf is submitted for euro so it is submitted to the drug regulatory authority of europe to provide confidential information of the api because as the name suggests active substance so it provides the confidential information about what api so it is a type of dmf and it is recognized term in the euro and it is also called as european drug master file and it can be used for the following active substance like what are the different type of active substances for which this uh you know uh the application is file in in that europe so the active substances if the active substances pharmacopoeial active substance if it is existing active substance which is not given in the european pharmacopoeia or if it is a new active substance okay so so we can file the active substance master file now coming to the marketing authorization procedure for pharmaceuticals in europe so like what how uh the product is basically going to the market so this is the procedure so firstly there is the first step is to file the marketing authorization application then there will be the rms and cms so what is rms rms is reference member state and cms is concerned member state so reference member state is selected by the applicant so whosoever wants to market a particular product so they will accordingly in a country so they will accordingly select the rms so rms is acts as a central point between member state and marketing authorization holder so it acts as a center point between marketing authorization holder and member state and it has to prepare the assessment report so rms has to prepare the assessment report so whatever the applicant filed their application so rms has to assess and let them know to cms okay so this maa the application going to rms and cms then the validation of that particular application is conducted by rms reference member state after the validation there will be the distribution of assessment report like whatever the rms assessed uh in that particular application so they will distribute the information to cms which is concerned member state so after that validation of application by cms then there will be another step validation also like the cms also validate that information of the application and if cms approves the assessment report like the assessment report by rms so if cms also approves so then marketing authorization will be given to the applicant for each cms which is concerned member state so concerned member state is all other member states where the company has submitted the dosia okay now so what are the different procedures for drug approval in europe like there are different procedures so that we can market our product in the euro so four types of drug procedure drug approval four types of procedures in the drug approval national procedure mutual recognition procedure centralized procedure and decentralized procedure now coming to one by one national procedure so the majority of the medicinal or the drug product are authorized to market in europe through this procedure okay and each european member state has its own national authorization procedures like in europe there are so many states so in each european member states has its own national authorization procedure and this national procedure is not in the scope of centralized procedure this procedure is very specific to particular national procedure okay and the assessment time like it will take two one zero days for their assessment the particular application they will assess in 210 days so for authorization of drug product in several member states like if the applicant wants to market a product in several member states so they will they will file the application by two procedures first is mrp and second is dcp so they will file by two procedures mrp or dcp so what is mutual recognition procedure so the medicinal product has already been received in a member state a market authorization at a time of application so in simple words we can say it is an application for the products are already licensed in the europe okay so when the product is already approved in that in the europe in in a different state so only then mrp will be considered so it is based on the medicinal products which are evaluated and approved by rms followed by a 90-day period where the cms consider the rms assessment report so cms is concerned member state and rms is reference member state i o as i already told you so assessment time for the mrp is 90 days plus 30 days for the national phase okay then decentralized procedure so it is to acquire the marketing authorization in several member states even though there are no marketing authorization has been granted so in mrp marketing authorization is compulsory okay so like if the if one ma is already approved like if one uh one drug product is already approved by a procedure national procedure so mrp will be considered but if there is no marketing authorization in the europe area so decentralized procedure can also be uh used for the marketing application so assessment time is 210 days plus 30 days 30 days for national phase now centralized procedure so it is only one single marketing authorization application to the european medicinal agency so it is a single marketing authorization and it is it it gives the transparent evaluation it do transparent evaluation single ma is valid in all european member states and this procedure is compulsory for most innovative medicines and for including rare diseases and the assessment time will be 210 days plus time taken by the european commission decision making process okay now coming to the last slide last topic the difference between nda and a nda so what is new drug application and abbreviated new drug application i already told you so what are the difference between this so in nda it is for application of applicable for new drug and for amd it is applicable for generic drug and nda will take longer time as compared to a nda so nda will take 12 to 15 years while a nda will take only one to two years okay so the cost of drug is more in ndf for nda and the cost of drug is less for alda so non-clinical and clinical studies are essential for nda okay but for amda these studies are not essential like non-clinical and clinical studies but bioavailability or bioequivalence studies are essential so thank you guys i hope you like the video so if you like the video please subscribe and please like please share the video please don&#39;t forget to hit the bell icon for latest notifications so thank you very much guys thank you

Transcript for:Drug Development and Regulatory Affairs

Transcript for:
Drug Development and Regulatory Affairs