Standard instructions for medical use of interchangeable drugs: analysis of modern regulatory documents

The article presents a review of modern regulatory and legal framework and draft regulatory documents on circulation of interchangeable drugs with regard to standard instructions for medical use. The analysis included more than 70 documents. There are two slightly different notions in this field: a generic drug and an interchangeable drug. A generic drug is not necessarily an interchangeable drug. The interchangeability of a drug is determined during pre-marketing evaluation. Some differences concerning normative requirements to the content of standard instructions for interchangeable drugs have been observed when comparing the regulatory framework of Russia, CIS countries and the EU. It is necessary to look not only at bioequivalence as an equivalent of interchangeability, but also take into account characteristics of excipients, and therapeutic equivalence based on preclinical and clinical trial results. The analysis of differences in regulatory documents can form the basis for further harmonization of requirements to instructions for medical use of interchangeable drugs.

типовая инструкция по медицинскому применению, взаимозаменяемые лекарственные препараты, нормативно-правовые документы, вспомогательные вещества, доклинические исследования, клинические исследования, обращение лекарственных средств, standard instruction for medical use, interchangeable drugs, regulatory and legal framework, excipients, preclinical studies, clinical trials, circulation of medicines

1. Federal Law of 22.12.2014,¹ 429-FZ «On Amendments to the Federal Law¹ 61-FZ «On Circulation of Medicines» (in Russian).

2. Decree of Government of the Russian Federation of 28.10.2015, ¹ 1154 «On the procedure for determining the interchangeability of drugs for medical use» (in Russian).

3. Federal Law of 21.11.2011, ¹ 323-FZ «On the bases of the health care of citizens in the Russian Federation» (in Russian).

4. Federal Law of 12.04.2010,¹ 61-FZ «On Circulation of Medicines» (in Russian).

5. The list of assignments of Chairman of the Government of the Russian Federation of 01.07.2014,¹ DM-P36 – 4825 (in Russian).

6. Helsinki Declaration of the World Medical Association «Ethical Principles for Medical Research with human as a subject» (in Russian).

7. The meeting of the CIS Economic Council of 17.06.2015, ¹ 66, St. Petersburg. The decision of the CIS Economic Council «On the state of competition in product markets medicines CIS member states». The report «On the state of competition in product markets medicines CIS member states» (in Russian).

8. The order of the Board of the Eurasian Economic of 29.12.2015, ¹ 187. On the draft decision of the Council of the Eurasian Economic Commission «On approval of requirements for medical application of drugs and the general characteristics of drugs for medical use» (in Russian).

9. The order of the Board of the Eurasian Economic Commission of 29.12.2015,¹ 187 «Template general characteristics of the drug». The application ¹ 10 to the Requirements for instructions on medical use of the drug and the general characteristics of the drug for medical use (in Russian).

10. Guidelines «Preparing text for medical use of the drug instructions». FGU «NÑESMP»; 2009 (in Russian).

11. Handbook RLS. Section «Medicine chest to test the interaction». Available from: www.rlsnet.ru (in Russian).

12. Otdelenov VA, Novakova AN, Karasev AV, Yashina LP, Payuschik SA, Sychev DA, et al. Evaluation of the frequency of potentially significant drug interactions in patients with polypharmacy in a multidisciplinary hospital. Klinicheskaya farmakologiya i terapiya 2012; (5): 81–5 (in Russian).

13. Interactions checker. Available from: www.drugs.com.

14. Order of the Ministry of Health and Social Development of Russia of 26.08.2010 ¹ 748n «On approval of the issuance of permits to conduct clinical studies of a drug for medical use» (in Russian).

15. Order of the Ministry of Health and Social Development of Russia of 26.08.2010¹ 757n «On approval of the procedure of monitoring the safety of medicinal products for medical use, registration of adverse events, serious adverse reactions, unexpected adverse reactions in the use of drugs for medical use» (in Russian).

16. Berezovskaya IV, Guskova TA, Durnev AD. Guidelines for security studies of generic drugs. Biomeditsina 2011; (3): 78–80 (in Russian).

17. Beregovyh VV, Meshkovsky AP. Rationing pharmaceutical production. Moscow: Remedium; 2001 (in Russian).

18. Zherdev VP, Kolyvanov GB, Litvin AA, Sariev AK. Harmonization of bioequivalence studies of drugs: problems and their possible solution. Eksperimentalnaya i klinicheskaya farmakologiya 2003; (2): 60–4 (in Russian).

19. Konyushkova AN, Savchenko AYu, Davydova KS, Ramenskaya GV, Kukes VG. Review of the requirements for bioequivalence studies of generic drugs. FDA Requirements. Remedium 2011; (5): 54–7 (in Russian).