WELCOME TO SEMINAR ON DRUG REGULATORY AFFAIRS

Preparad by:K.SLRAO(mpharm.1yr)

DEFINATION:

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

 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

Licensing Registration

Development
Manufacturing Quality Guidance Pricing Marketing

Pharmacovigilance
GMP ,GLP ,GCP, Patent, Copyright ,Trademark

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.

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 &

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.

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

THANK YOU