Introduction to Regulatory Affairs Here is my first post related to Regulatory Affairs! Affairs! What is Regulatory Affairs? Regulatory Affairs is a profession within regulated industries namely-pharmaceuticals, medical devices, energy and banking. It has specific meaning within healthcare industries namely- pharmaceuticals, medical devices, biologics and functional foods.(n this blog am going to deal about Regulatory Affairs related to pharmaceuticals meant for human use. Regulatory Affairs in the pharma industry may be defined as "The "The interface between the pharmaceutical company and the regulatory agencies across the world
n the above presentation, am conveying the fact that -among all the departments of a pharma company Regulatory Affairs Affairs #epartment acts as the interface between the pharmaceutical company and the regulatory agencies across the world. Regulatory agency in the prese Regulatory present nt conte$t may be define defined d as "The "The competent government agency which is responsible for ensuring that medicines work and are acceptably safe. safe."
Origin of Regulatory Affairs•
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Elixir Sufanilamide, prepared using DEG (a poison) as solvent resulted in the death of more than 100 people in the USA in 1!"# $his in%ident led to the passing of the 1!& 'ederal 'ood, Drug and osmeti% a%t in USA# $halidomide use * pregnant pregnant +omen for treating treating morning si%ness si%ness +as lined to the %ause of irth deformities in more than 10,000 %hildren in late 1-0s and earl* 1.0s# $his in%ident led to Amendment in USA/it is a 1. amendment to the 'ederal 'ood, Drug and the Kefauver-Harris Amendment in %osmeti% a%t# Similarl*, other tragi% in%idents led to various a%tsamendments# a%tsamendments# Goals of Regulatory Affairs as profession-
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%rotection of human health
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&nsuring safety,efficacy safety,efficacy and 'uality of drugs
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&nsuring appropriateness and accuracy of product information
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Roles of Regulatory Affairs professionals Act as a liaison with regulatory agencies %reparation of organied and scientifically valid )#A, A)#A,)#A ,*AA,#*+ ,*AA,#*+ submissions &ns nsur ure e ad adh her eren enc ce an and d guidelines, regulations and laws
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%roviding e$pertise and regulatory intelligence in translating regulatory re'uirements into practical workable plans Advising the companies on regulatory aspects and climate climate that would affect their proposed activities
Apart from the aove main roles, there are various other roles +hi%h 2egulator* A3airs professionals pla*# )ow,coming )ow,c oming to the most important part of this post-
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What work is done in Regulatory Affairs epartment? A new drug/generic drug manufactured by a pharmaceutical company 0ust cannot be released into the market for human use.
Here the Regulatory Affairs #epartment comes into play.
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Regulatory Affairs #epartment of a pharmaceutical company files all the information related to the development, manufacture, control, stability studies, packing, labeling , safety and efficacy studies of drugs with the Regulatory agencies in a prescribed format as A)#A/)#A/*AA/#*+ etc. 1he Regulatory agency reviews the information provided in accordance with regulations, guidelines and if they are satisfied with information provided, approval will be granted for marketing of the drug by pharmaceutical companies for human use.
General work prole of a Regulatory Aairs professional in an API (Ative P!armaeutial Ingredient" manufaturing ompany'iling a D4'AS4' +ith regulator* agen%ies in support of the 5DAA5DAI5DA4AA 6led * a 'ormulator (Drug 7rodu%t manufa%turer +ho uses A7I of that parti%ular A7I manufa%turing %ompan*)# 'iling dossier of A7I +ith ED84 for otaining E7#
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Assessing and 6ling amendmentsvariations to the information (+hi%h ma* e related to manufa%ture, %ontrol, stailit* studies et% ) in D4'AS4'Dossier of parti%ular A7I +ith the 2egulator* agen%ies# 4a9or amendments are to e reported prior to their implementation +hile minor amendments ma* e reported annuall*# $he %lassi6%ation of amendments +ill e dealt in the later posts# $aing approval of %ustomers of A7I efore implementing an* ma9or %hanges regarding the information mentioned in D4'AS4'Dossier# $he updated D4'AS4' ma* e sumitted to the %ustomer simultaneously along +ith amendmentsvariations 6led +ith the agen%*# 7reparing and sumitting :pen partAppli%ant;s part of D4' to the %ustomers of A7I (Drug produ%ts manufa%turer) +hi%h ma* e 6led * %ustomer +ith the 2egulator* agen%*# 7reparing and sumitting the
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the A7I# •
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'iling Annual=iannual8uin>uennial reports (?hi%h %ontain list of %hanges to the D4'AS4'Dossier) +ith the regulator* agen%ies# 4aintenan%e of the %omplete histor* of ea%h A7I ('iling histor* +ith agen%ies%ustomers, amendments, annual reports)# $aing part in the drug development pro%ess * advising the 2 @ D s%ientists regarding various guidelines,la+s and regulations# 5ote Apart from the aove +or pro6le there ma* e other responsiilities for 2egulator* A3airs professionals too#
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General work prole of a Regulatory Aairs professional in a $rug Produt %&inis!ed produt%&ormulation manufaturing ompany 'iling a 5DAA5DA4AA of drug produ%ts +ith regulator* agen%ies for getting mareting approval# Assessing and 6ling supplementsamendmentsvariations to the information (+hi%h ma* e related to manufa%ture, %ontrol, stailit* studies et% ) in 5DAA5DA4AA +ith the 2egulator* agen%ies for prior approval or after their implementation# 4a9or supplementsamendments are to e reported prior to their implementation +hile minor supplementsamendments ma* e reported annuall*# $he %lassi6%ation of amendments +ill e dealt in the later posts# 'iling Annual=iannual reports (?hi%h %ontain list of %hanges to the 5DAA5DA4AA) +ith the regulator* agen%ies# 2eporting an* adverse e3e%ts +hi%h have o%%urredma* o%%ur due to the use drug produ%ts# 4aintenan%e of the %omplete histor* of ea%h Drug produ%ts ('iling histor* +ith agen%ies%ustomers, amendments, annual reports) $aing part in design and revision of drug produ%t laels, pa%ing leaBets# $aing part in the 'ormulation development pro%ess * advising the 2 @ D s%ientists regarding various guidelines,la+s and regulations#
5ote Apart from the aove +or pro6le there ma* e other responsiilities for 2egulator* A3airs professionals too#
P' ou may )e wondering w!at t!e a))reviations *$A+A*$A+ ,P et are all a)out..////
I am presenting t!e full forms of all t!e a))reviations )elow and wil l e0plain t!em in my ne0t post. !A- )ew #rug Application A!A- Abbreviated )ew #rug application "!A - nvestigational )ew #rug Application #AA - *arketing Authorisation Application #$ - #rug *aster file A%#$ -Active 2ubstance *aster +ile &'(- ertificate of suitability to the monograph of &uropean %harmacopoeia cG#(- urrent good *anufacturing %ractice "&),- 1he nternational onference on Harmonisation of technical re'uirements for registration of %harmaceuticals for human use. G&(- ood clinical %ractice G*(- ood aboratory %ractice
