DRUG REGULATORY AFFAIRS

It includes information about regulatory bodies, role of drug Regulatory professional, countries with their regulatory bodies, intellectual property rights, terminologies related to DRA, drug approval process, event regarding lack of Drug regulatory affairs

1. Course Structure and content for PRACTICE SCHOOL ( BP706Ps ) Final year Bpharm (sem VII) Domain – 8 Drug Regulatory affairs

2. A Review Article by- Rujuta Namdev Bhor Final year Bpharm (1952811823004) Guided by – Dr Sushil patil

3. INDEX Introduction Role of regulatory bodies Professionals in drug Regulatory Authority Countries with their regulatory bodies Intellectual property rights Terminologies related to DRA Drug approval process Events regarding lack of regulatory affairs Regulatory bodies in different countries. Conclusion

4. INTRODUCTION DRUG REGULATORY AFFAIRS- Regulatory affairs is also term as government affairs because it follows the rules given by government authorities to fullfill all the needs of pharmaceutical products. Regulatory affairs is nothing but collecting, analysing , communicating, understanding the risk and benefits of health care products to regulatory agencies and public all over the world. It has broad spectrum covering all aspects of documentation and marketing in the legalized form. Regulatory professional give advise to company both starategically as well as technically at there highest level for better health care . They provide tactical as well as practical advice at top level of their companies to stand in global market.

5. ROLE OF REGULATORY AFFAIRS AUTHORITIES - Development of new drug product Manufacturing of that product Marketing of the product Post marketing of that product Regulatory authorities initiated from government to protect public health by controlling Safety Efficasy Quality.

6. Regulatory authority - Regulatory authority involve the registration of drug products in repsects of countries prior to their marketing. There are two types of Regulatory bodies – Domestic regulatory affairs (DRA)- it is basically country originated . International regulatory affairs (IRA)- It is other than country origine. Pharmaceutical Industry Regulatory affairs Interface between Drug regulatory Authority (worldwide)

7. Professionals In DRA- DRA professionals plays important role in all of this phases from devlopment of new products to marketing of product . DRA professionals have thorough knowledge of domestic regulations as well as international regulations with its scientific background. DRA professionals should also have the updated information in global pharmaceutical market. DRA professionals must actively participate in discussion and co ordinate team activity to obtain all necessary documents and access for accuracy.

8. Countries and their regulatory authorities Çountries Name Of Regulatory Authorities USA Food and Drug Administration (FDA) UK Medicines and Healthcare Products Regulatory Agency (MHRA) INDIA Central Drug Standard Control Organization (CDSCO) CANADA Health Canada ITALY Italian pharmaceutical Agency UKRAIN Ministry Of Health CHINA State Food and Drug Administration JAPAN Ministry of Health, Labour and welfare EUROPE European Medicines agency (EMEA)

9. CDSCO- (Central Drug Standard Control Organization) CDSCO is the centrally located drug Regulatory body situated in new delhi . The head of CDSCO is dr V.G.Somani. Who is directorate general of India . It works under Directorate General Of Health Services Ministry Of Health And Family Welfare Government of India. Vision – To protect and promote public health in India. Mission - To safeguard and enhance the public health by assuring safety, efficacy and quality of drugs,medical devices and cosmetics. 379 members are working there.

10. Healthcare Industry , Intellectual Property Rights (IPR)- Copyright- Copyright is one of the type of intellectual property rights that gives its owner exclusively right to Copy , distribute,display there work. Trademark – . Trademark is also under intellectual property rights It is the symbol Word Which is legally register. Patent – . Patent is type of intellectual property rights which give its owner right to from making, selling, using the inovation .

11. Terminologies related to DRA- Name Full forms NDA New Drug Application INDA Investigational New Drug Application ANDA Abbrivated New Drug Application MAA Marketed Authorisation Application DMF Drug Master File CMC Chemistry Manufacture And Control ICH International council of Harmonisation Orange book Involve approved drug products with therapeutic equivalence evaluation CTD Common Technical Document ASMF Active Substance Master File CMS Concerned member state RMS Reference Member state

12. Drug development / Approval process - Basic research and Target discovery Drug Discovery Pre-clinical Testing IND Submission and review by FDA Clinical Trials NDA Submission review by FDA FDA Approval Manufacture and marketing

13. Events Caused due to lack of Awareness about DRA- Banned Artemis Biotech , Hyderabad pharma company – . FDA found concern there about the API production This company produced SIMVASTATIN As an API and market in US market but there is lack of quality which is seen by the USFDA Committee due to this FDA banned the product .

14. Pfizer Hospira plant- Pfizer also acknowledge about a week ago that it had temporarily suspended production at hospira Plant in Chennai, India . Hospira plant do the production of TB drugs which are marketed in US Market . After checking by USFDA found concern there so banned until the changes are done which are needed.

15. LAXACHEM, Amravati, Maharashtra Contaminated Docusate Sodium was seen by USFDA while investigation This Docusate Sodium causes the infection of B-cepacia and Burkholderia cepacia. Due to this cepacia infection there is bacterial resistant to the antibiotic.

16. Different forms filing by DRA - IND- It is an application to get approval for conducting a human clinical trials and shipping of experimental drug for investigation purpose There are 3 types of application form- Investigator IND TREATMENT IND (life threatning condition) Emergency use IND.

17. Drug Master File (DMF)- Submission to FDA which provide confidentiality details information. Facilities Procces used for manufacturing. Packaging Storage of drugs Chemistry,component of drug product.

18. TYPES OF DRUG MASTER FILE- Types of DMF Information about DMF TYPE - 1 Manufacturing site , facilities,operating procedure ,personnel. TYPE - 2 Drug substance,drug products TYPE - 3 Packaging meaterial Type - 4 Excipients,flavoured,colourants ,essense.

19. NDA It is an application which filed with FDA to market a new pharmaceutical drug products for sale in USA. APPLICATION – It involves data of animal studies and human clinical trials.

20. ANDA FILING – ANDA means ABBREVIATED NEW DRUG APPLICATION. There are 4 types of form- PARA 1 FILING-. This form is for those drugs which are not having patent. PARA 2 FILING – This made when drug is already off Patent nor expired. PARA 3 FILING – . Patent will expire on particular date . PARA 4 FILING- . Patent is invalid

21. MARKETED AUTHORISATION APPLICATION (MAA)- This application is for new drug in Europe for permission to bring developed pharmaceutical products to market . DRUG MASTER FILE (DMF) is for US country only and ACTIVE SUBSTANCE MASTER FILE (ASMF) is for European countries .

22. Procedure for drug approval in Europe- There are 4 type of procedure National procedure – . This one is for overall drugs for registration, Req 210 days for access. Mutual Recognition procedure (MRP)- . It is for allready approved drug in Europe , it takes 90 days for CMF and RMF + 30 days (national phase ). Centralised procedure – this one for rare disease and innovative medicine, It takes 210 days + time taken by EU commission . Commission for decision making . De Centralised procedure - . This one is for several member state , 210 days + 30 days ( national phase ).

23. Conclusion - Regulatory affairs is not only the registration of drug product but they gives the practical as well as tactical knowledge to company to stand in this developing globe. Regulatory professionals works as they give proper knowledge of record keeping, data management, inappropriate scientific background to company for there growth. For the better and healthy lifestyle the regulatory authority works by improving quality and safety, efficacy of drug product.

24. References - Role of regulatory affairs in Pharmaceutical industries, Sohail Ahmed, Sujata bhati, International journal of Scientific research In science and technology. Vol 9 , issue -4 ,Pg no 336. Overview of drug Regulatory affairs and regulatory profession, Badjatya jitendra kumar*, International Journal Of Drug Regulatory Affairs, ISSN:2321-6794. https://youtu.be/M_GOym_EuyM https://ich.org/ https://cdsco.gov.in/opencms/opencms/en/Home/

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