Drug Regulatory AffairsThe Backbone of Pharmaceutical Industry : Presented By:-
Department of Pharmaceutical Technology
M.I.E.T., Meerut Drug Regulatory AffairsThe Backbone of Pharmaceutical Industry 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…………….. What is Drug Regulatory Affairs? 2 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 than 8 to 15 years 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. Why does a DRA department required in a Pharmaceutical organisation? 3 Which departments are assisted by DRA department? : Drug Regulatory Authorities
(across the world) CDSCO- India
USFDA- United States
MHRA- United Kingdom
MCC- South Africa Product Development
Clinical Research & Trials
Quality Assurance & control
Marketing Which departments are assisted by DRA department? Internal Departments Of Organization 4 On what Issues does DRA department provide assistance? : On what Issues does DRA department provide assistance? Licensing
…….& many more. 5 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. What are the different applications filed by DRA department? 6 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 What are the Documents Prepared and/or maintained by DRA department? 7 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. What are the functions of DRA department? 8 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. What does it conclude? 9 Slide 10: 10 References : Ahuja Alka, Sultana Yasmin, Baboota Sanjula , Ali Asgar; “An Introduction to Pharmaceutical drug regulatory affairs”; Excel Books Pvt. Ltd., 2005, Pg. no. 19-21.
Pendergast William R., McMurray Raymond D.; “Drug Regulatory affairs”, In: The theory and practice of industrial Pharmacy; Edition 3rd, Varghese Publishing House, 1990, pg.no.856-875.
cdsco.nic.in 11 References Thanks for giving your precious attention and time…… : Lovenish Bhardwaj Thanks for giving your precious attention and time……