Regulatory Affair (Introduction) _Afzal Bano.pptx

*RA or government affairs, is a profession involved in monitoring and regulating the development, manufacture, testing and marketing of products from a range of industries.

*Regulatory affairs is vital to the proper functioning of societies and economies.

*It is a profession that acts as the interface between the Pharmaceutical industry and drug authorities in the world

1. REGULATORY AFFAIRS By Afzal BANO

2. What is Regulatory affairs? RA or government affairs, is a profession involved in monitoring and regulating the development, manufacture, testing and marketing of products from a range of industries. Regulatory affairs is vital to the proper functioning of societies and economies. It is a profession that acts as the interface between the Pharmaceutical industry and drug authorities in the world

3. Importance of RA Regulatory Affairs Consultants who are responsible for the protection and safety of human health; ensure the safety, efficacy, and quality of drugs; and ensure that the product is intended for use only where it is appropriate. To fulfill these goals: · Regulatory Affairs Consulting Services work as per the guidelines of regulatory agencies, prepare and compile documents like NDA, ANDA, INDA, MAA, and DMP that are required by regulatory authorities. ·  Make sure that all the processes involved comply and adhere to the applicable guidelines and regulations like cGMP, ICH, GCP, GLP, etc.

4. Advice and strategize workable plans that would help the company get its product into the market while abiding by the regulatory guidelines. Hence, the general work profile of a Regulatory Affairs Consultant in a pharmaceutical company includes filing DMFs and dossiers, being up to date with any amendments released by regulatory authorities, and maintaining and submitting all the documents required for the approval of a drug to be marketed. To sum it up, the Regulatory Consultants act as a bridge between a pharmaceutical company and regulatory authorities to get the product into the market.

5. Thalidomide Tragedy In 1937, Elixir Sulfanilamide which was marketed without any marketing testing caused deaths of more than 100 people in the USA. The pharmaceutical company added DEG as a solvent along with raspberry flavor for Sulfanilamide to be used as an elixir. This created an outrage and finally, led to the Federal Food, Drug and Cosmetic Act in 1938.

6. However, the tragic incidents did not end there, there were many which led to various acts and amendments and one of the impactful being the “Thalidomide Tragedy”. The drug thalidomide was given to pregnant women to control morning sickness; however, it was late until it was realized that children were born with phocomelia because of the drug intake, and a major amendment was made to the Federal Food, Drug, and Cosmetic Act in 1962.

7. Drug development/APPROVAL PROCESS

8. aBBREVIATIONS NDA- NEW DRUG APPLICATION INDA –INVESTIGATIONAL NEW DRUG APPLICATION ANDA- ABBREVIATED NEW DRUG APPLICATION MAA –MARKETING AUTHORIZATION APPLICATION DMF-DRUG MASTER FILE ICH- INTERNATIONAL COUNCIL FOR HARMONISATION cGMP –CURRENT GOOD MANUFACTURING PRACTICES GLP- GOOD LABORATORY PRACTICES GCP – GOOD CLINICAL PRACTICES

9. REGULATORY AUTHORITIES OF DIFFERENT COUNTRY USA UK EUROPE AUSTRALIA BRAZIL CHINA JAPAN United States Food And Drug Administration Medicines And Healthcare Products Regulatory Agency European Medicines Evaluation Agency Therapeutic Goods Administration Agencia National De Vigilancia Sanitaria State Food And Drug Administration Ministry Of Health, Labour And Welfare USFDA MHRA EMEA TGA ANVISA SFDA MHLW

10. Thank You