Regulatory affairs

• 1.Drug Regulatory Affairs The Backbone of Pharmaceutical Industry .

2.

• What is Drug Regulatory Affairs? :

• Drug Regulatory affairs (DRA) is a process of interaction of the company with :

• Drug Regulatory Authorities

• Internal Departments of the Organization

• .Through out the lifecycle of a product, that is from the synthesis of the active moiety to marketing to post approval activities..

3.

• Why does a DRA department required in a Pharmaceutical organisation? :

• Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products.

• It takes more than8 to 15years to develop a new drug product & costs more than$ 800 million .

• Regulatory affairs provides insight/guidance into this development through agency wisdom collected in guidance, previous experience, market precedence, etc. and hence helps to reduce number of development failures.

4.

• Which departments are assisted by DRA department? :

• Drug Regulatory Authorities (across the world) CDSCO- India

• USFDA- United States

• EMEA-( Europe, the Middle East and Africa) European countries

• MHRA- (Medicines and Healthcare products Regulatory Agency)United Kingdom

• TGA- Australia

• MCC- (Medicines Control Council)South Africa

• Product Development

• Clinical Research & Trials Licensing

• Manufacturing

• Quality Assurance & control Marketing

5.

• On what Issues does DRA department provide assistance? :

• Licensing

• Registration

• Development

• Manufacturing

• Quality Guidance

• Pricing Marketing

• Pharmacovigilance

• GMP ,GLP ,GCP, Patent, Copyright ,Trademark .& many more.

6.

• What are the different applications filed by DRA department? :

• Investigational New Drug Application (IND) New Drug Application (NDA)

• Abbreviated New Drug Application (ANDA) Biological License Application (BLA)

• For Market Authorization

• For GMP certification

• For getting Certificate of Pharmaceutical Products For obtaining Patent, Copyright and Trademark registration. & many more.

7.

• What are the Documents Prepared and/or maintained by DRA department? :

• Licenses and certificates obtained by Drug regulatory Authorities, Eg. Mfg. License, GMP, CoPP, ISO etc.

• Common Technical Document (CTD/eCTD) ASEAN Common Technical Document (ACTD) Drug Master File

• Clinical Trial Reports

• Bioavailability & Bioequivalence reports Quality Audit files and reports & others

8.

• What are the functions of DRA department? :

• Provide regulatory and technical inputs for product development.

• Prepare, review and submit different regulatory submissions.

• Act as interface between internal department of organization.

• Review and submit Annual drug reviews, Adverse drug experience, recall coordination activities and different regulatory guidelines.

• Answer and negotiate with the Drug regulatory authorities on various issues on drug registration. Apply for the various certifications and arrange for the audit and also work on their renewal. .& many more.

9.

• What does it conclude? :

• The above discussion proves that the DRA department is providing its full support to all the department of a pharmaceutical organization and also to the Drug Regulatory authorities on all aspects of Drug development process.

• This in turn helps to avoid any delay or problems that can arise in future relating to the Product, hence save a lot of time, efforts and expenditure. So, We can say that the DRUG REGULATORY AFFAIRS, is really a BACKBONE of the Pharmaceutical industry.

10.