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Drug registration according to the rules of the EAEU: jump into the last carriage

11/25/2019 | EAEU, drug registration, FSBI NTsESMP

On November 20, on the final day of the Scientific and Practical Conference "Modern Approaches to the Expertise of Medicines" - "RegLek" a section was held devoted to the unified market of medicines of the EAEU. Ekaterina Rychikhina, Head of the Control and Organizational Directorate of FSBI “SCEEMP” of the Ministry of Health of Russia, said why it is not worth putting off bringing the dossier into compliance at the last moment.

The introduction of new laws and regulations almost always causes difficulties, and pitfalls are discovered during the transition. In terms of registration of drugs according to the rules of the EAEU and the ghosting of dossiers in accordance, they also exist, and one of them is the deadlines. They were installed in such a way as to ensure a smooth transition, and manufacturers had time to prepare and adapt. The documents determine the final date when the registration certificates and dossiers of all medicines registered in the EAEU member states must be brought into line with the requirements of the union. This deadline is December 31, 2025.

“The deadlines for submitting applications are clearly specified. For state registration - the deadline for submitting applications is December 31, 2020. To confirm the registration - the deadline for submitting applications for drugs for which RUs were issued before June 6, 2017. To make changes - the deadline for submitting applications is until December 31, 2025 for drugs for which RUs were issued before June 6, 2017, ” recalled Ekaterina Rychikhina.

Also, the documents on the single market for the circulation of medicines and medical devices within the EAEU contain a norm according to which the state does not allow confirmation of registration certificates issued after the entry into force of the agreement on February 12, 2016. And here the question arises of drugs first registered in the Russian Federation after February 12, 2016, with registration certificates valid for 5 years. For them, the procedure for confirming state registration will soon be unavailable, and they need to bring the dossier in line as soon as possible. There are a lot of such drugs, according to the expert.

“In total, from February 12, 2016, in the Russian Federation, according to national legislation, the Ministry of Health filed 2515 applications, some of which are still under examination. 1957 applications have been submitted for amendments since May 6, 2017 under Russian national legislation, some of which also remain under examination. A number of applications relate to drugs in the registration dossier of which, starting in 2021, it will be impossible to amend national legislation. What should applicants do if necessary to amend the registration dossier? It is necessary to bring it into line with the EAEU requirements now, by the end of 2020, ” said Yekaterina Rychikhina.

She also noted that despite certain difficulties that manufacturers have in connection with the transition to the rules of the EAEU, the current practice of the Ministry of Health of the Russian Federation has positive features. For example, the fact that drug registration is a public service, and drug registration according to the rules of the EAEU and confirmation of changes to bring it into compliance are administrative procedures. Assessing the applicants' activity, the head of the control and organizational department of the FSBI “SCEEMP” of the Ministry of Health of Russia expressed the opinion that it is insufficient.

“To date, the activity of applicants under the EAEU procedures, in our opinion, is very low. We have received a total of 7 registration tasks, and 34 applications for alignment. Why is it so important to talk about deadlines? Because the window of opportunity is narrowing not only for drugs planned for registration under the requirements of 61FL, but also for registered drugs. Given the current trend and the applicants' habit of doing everything at the last moment, we expect a large flow of applications at the end of 2020. This means that it is then that all the forces of the company registration units will be thrown in order to have time to jump into the last carriage, and the Ministry of Health will be littered with a dossier, and all of 2021 will dismantle these blockages. Therefore, taking into account the limitations that we have discussed, let us make efforts to change the picture, ” Ekaterina Rychikhina urged.

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