Regulatory affairs


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Regulatory affairs

  1. 1. Drug Regulatory Affairs The Backbone of Pharmaceutical Industry .
  2. 2. <ul><li>What is Drug Regulatory Affairs? : </li></ul><ul><li>Drug Regulatory affairs (DRA) is a process of interaction of the company with : </li></ul><ul><li> Drug Regulatory Authorities </li></ul><ul><li> Internal Departments of the Organization </li></ul><ul><li>…………… .Through out the lifecycle of a product, that is from the synthesis of the active moiety to marketing to post approval activities…………….. </li></ul>
  3. 3. <ul><li>Why does a DRA department required in a Pharmaceutical organisation? : </li></ul><ul><li>Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. </li></ul><ul><li>It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million . </li></ul><ul><li>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. </li></ul>
  4. 4. <ul><li>Which departments are assisted by DRA department? : </li></ul><ul><li>Drug Regulatory Authorities (across the world) CDSCO- India </li></ul><ul><li>USFDA- United States </li></ul><ul><li>EMEA-( Europe, the Middle East and Africa) European countries </li></ul><ul><li>MHRA- (Medicines and Healthcare products Regulatory Agency)United Kingdom </li></ul><ul><li>TGA- Australia </li></ul><ul><li>MCC- (Medicines Control Council) South Africa </li></ul><ul><li>Product Development </li></ul><ul><li>Clinical Research & Trials Licensing </li></ul><ul><li>Manufacturing </li></ul><ul><li>Quality Assurance & control Marketing  </li></ul>
  5. 5. <ul><li>On what Issues does DRA department provide assistance? : </li></ul><ul><li>Licensing </li></ul><ul><li>Registration </li></ul><ul><li>Development </li></ul><ul><li>Manufacturing </li></ul><ul><li>Quality Guidance </li></ul><ul><li>Pricing Marketing </li></ul><ul><li>Pharmacovigilance </li></ul><ul><li>GMP ,GLP ,GCP, Patent, Copyright ,Trademark …….& many more. </li></ul>
  6. 6. <ul><li>What are the different applications filed by DRA department? : </li></ul><ul><li>Investigational New Drug Application (IND) New Drug Application (NDA) </li></ul><ul><li>Abbreviated New Drug Application (ANDA) Biological License Application (BLA) </li></ul><ul><li>For Market Authorization </li></ul><ul><li>For GMP certification </li></ul><ul><li>For getting Certificate of Pharmaceutical Products For obtaining Patent, Copyright and Trademark registration. ……………& many more. </li></ul>
  7. 7. <ul><li>What are the Documents Prepared and/or maintained by DRA department? : </li></ul><ul><li>Licenses and certificates obtained by Drug regulatory Authorities, Eg. Mfg. License, GMP, CoPP, ISO etc. </li></ul><ul><li>Common Technical Document (CTD/eCTD) ASEAN Common Technical Document (ACTD) Drug Master File </li></ul><ul><li>Clinical Trial Reports </li></ul><ul><li>Bioavailability & Bioequivalence reports Quality Audit files and reports ……& others </li></ul>
  8. 8. <ul><li>What are the functions of DRA department? : </li></ul><ul><li>Provide regulatory and technical inputs for product development. </li></ul><ul><li>Prepare, review and submit different regulatory submissions. </li></ul><ul><li>Act as interface between internal department of organization. </li></ul><ul><li>Review and submit Annual drug reviews, Adverse drug experience, recall coordination activities and different regulatory guidelines. </li></ul><ul><li>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. </li></ul>
  9. 9. <ul><li>What does it conclude? : </li></ul><ul><li>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. </li></ul><ul><li>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. </li></ul>