Regulatory affairs

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Text of 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.