Registration of medicines in the EAEU - the features and differences from the registration of drugs in the Russian Federation?
As you know, the renewal and reformatting of the pharmaceutical industry in Russia is one of the priority directions of recent Russia's development avenues, which is under the close attention of the Russian government, foreign pharmaceutical producers, investors and legislators. In order to make the development strategy of Pharma 2020 extend in correct direction, in recent years a series of laws and regulations were adopted regarding the circulation of medicines that significantly changed the process of drug registration in Russia. These changed forced Russian pharmaceutical manufacturers to comply their manufacturing plants with GMP requirements and caused a boom of drug registrations in Russia under the new rules. It is not surprising also that that new pharmaceutical plants are being built by both Russian investors and foreign pharmaceutical companies, since the localization of pharmaceutical production in the Russian Federation can significantly facilitate competition in such highly competitive segments of the Russian pharmaceutical market as the DLO and hospital markets.
Thus, the procedure for registration of medicines in Russia has undergone many changes over the past few years, significantly influenced by the fact that since May 2017 the common market for the circulation of medicines in the EAEU has started its functioning. It is expected that processes of development, preclinical and clinical research, quality monitoring, registration, production and sale of medicines under general procedures will be executed, according to the supranational standards of the common market. Thus, drug manufacturing companies receive uniformed standards for the manufacture, research and marketing of their pharmaceutical products.
At the moment, registration of medicines in Russia is carried out according to the national procedure rules by Federal Law No. 61-FZ "On the circulation of medicines" (hereinafter referred to as the "Law on the Treatment of medicines") of 2010, and Federal Law No. 429-FZ "On Amendments to Federal Law No. 61-FZ "On the circulation of medicines" (hereinafter referred to as the "Law on the circulation of medicines"), which was signed by the President of the Russian Federation on December 22, 2014.
According to these laws, the procedure for the national registration of drugs in Russia has been substantially modified and became more complicated. It should not be expected that, in connection with the commencement of the work of the common market for the circulation of medicines in the EAEU, the state procedure for drug registration in Russia will become simpler.
Recently the rules for drug registration and examination of medicines in the EAEU were adopted. According to these rules, there are uniformed rules and requirements for drug registration for the member countries of the EAEU. Until December 31, 2020, the manufacturer can choose how he will register his medicines - according to the national registration procedure or according to the inified registration process. After this date, all medicines will be re-registered under the common drug registration procedure in the EAEU. At the same time, GMP certification will be carried out according to the new rules with the receipt of the GMP certificate of the EAEU. The unified procedure for drug registration in EAEU can be performed in 2 ways:
- Registration of medicines under a centralized procedure. In this case, the registration of the drug conducted consecutively, that is, firstly the drug registration executed in the reference state (at the choice of the applicant) within 210 calendar days, and then the registered drug passes the registration procedures in the states of recognition (at the option of the applicant) within 100 calendar days. In this case, the applicant may not register the medicinal product in those states of recognition in which he is not going to deliver his drugs.
- The registration of a drug under a decentralized procedure is executed simultaneously in several Member States, with the applicant choosing the reference State. The period of registration of a medicinal product under a decentralized procedure is 210 calendar days from the date of submission of the last application to the state of recognition.
It's no secret that, compared to other countries-members of the EAEU, Russia has the most complicated and expensive drug registration procedure. It should not be expected that in connection with the new rules for registering drug in the EAEU, this process will be somehow simplified or become less expensive. The manufacturer should clearly understand that the common procedure for drug registration and examination of medicines in EAEU is aligned with the Russian complicated and expensive procedure for drug registration, but not the other way around.
So, it is already known that the rights to register medicinal products for circulation on the common market of the EAEU will be transferred to the Ministry of Health of Russia In addition, at the moment the state duty for drug registration differs significantly in the member countries of the EAEU. In Russia, until recently, it was the highest among other countries of the EAEU.
The fact that all procedures for registration of medicines in the EAEU are aligned with the process of drug registration in Russia is also indicated by the fact that the state fee for the registration of drugs in the EAEU was unified by the EAEU committee and now fully corresponds to the amount of state duties in Russia related to the procedure of drug registration and examination of medicines.
Thus, as analysts say, considering the above mentioned facts, nobody should expect that with the introduction of new rules for registration of medicines in the EAEU, manufacturers got the opportunity to register a drug in a member state of the EAEU under a simplified and cheaper scheme, and then sell their medicinal products in the territory of the EEAU to other countries of this union.