Russian and foreign legislation on regulation of post approval variations in the dossier for the medicinal products

Drug licensing is the most crucial factor for effective market regulation of pharmaceuticals. The rapid development of the pharmaceutical industry, emergence of new scientific data, and changes in composition of medicinal products drive the need for introduction of variations in original registration dossiers. The process of such variation approval implemented in a particular country is the key factor in assessing the effects of the variation on the quality, safety and efficacy of the medicinal product, and sets a timelines for their realization. The present article describes existing classifications of variations, which are adopted in the European Union (EU), USA and Russia. Also the article concerns the upcoming changes in Russia in the scope of Eurasian Economic Union establishment and the necessity of harmonizing the procedure with the European Union.

лекарственные препараты, пострегистрационные изменения, классификация изменений, руководства, нормативные документы, drugs, post-approval variations, classification, guidelines, normative documents

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2. Public Consultation Paper. Better Regulation of Pharmaceuticals: Towards a Simpler, Clearer and More Flexible Framework on Variations. European Commission, October 2007.

3. Commission Regulation (EC) No 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorization falling within the scope of Council Regulation (EEC) № 2309/93.

4. Commission Regulation (EC) № 1234/2008 of 24 November concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products. Official Journal of the European Union, L 334/7–24.

5. Commission Regulation (EU) № 712/2012 of 3 August 2012 amending Regulation (EU) № 1234/2008 concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products. Official Journal of the European Union, L 209/4-14.

6. Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) № 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures. European Commission, Brussels, 2013.

7. Practical questions and answers to support the implementation of the variations guidelines in the centralized procedure. EMA/427505/2013.

8. European Medicines Agency post-authorization procedural advice for users of the centralized procedure. EMEA-H-19984/03.

9. Changes to an approved application. Code of Federal regulations, title 21, volume 7, part 601 – licensing, subpart C- biologics licensing, Sec. 601.12.

10. Supplements and other changes to an approved application. Code of Federal regulations, title 21, volume 5, part 314 – application for FDA approval to market a new drug, subpart B- applications, Sec. 314.70.

11. Changes to an Approved NDA or NDA. Guidance for Industry, U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), April 2004.

12. Changes to an Approved Application: Biological Products. Guidance for Industry, U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), July 1997.

13. Immediate Release Solid Oral Dosage Forms. Scale up and Post-approval Changes: chemistry, manufacturing and controls, in vitro dissolution testing and in vivo bioequivalence documentation. Guidance for industry, Center for Drug Evaluation and Research (CDER), November 1995.

14. BACPAC I: Intermediates in drug substances synthesis. Bulk Actives Post Approval Changes: chemistry, manufacturing, and controls documentation. Guidance for industry, U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), February 2001.

15. Changes to an Approved NDA or ANDA Questions and Answers. Guidance for industry, U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), January 2001.

16. Q8(R2) Pharmaceutical Development. International Conference on Harmonization; 2009.

17. ICH Q9 Quality Risk management. International Conference on Harmonization; 2006.

18. ICH Q10 Pharmaceutical Quality System. International Conference on Harmonization; 2008.

19. ICH Q11 Development and manufacture of drug. International Conference on Harmonization; May 2012.

20. ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Final Concept paper. International Conference on Harmonization; 2014.

21. ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Final Business Plan. International Conference on Harmonization; 2014.

22. On circulation of medicines. Federal Law № 61-FZ, 12.04.2010 (in Russian).

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