FSI «SID & GP»
The Ministry of industry and trade of the Russian Federation
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Consolidated work of the regulatory authorities of the EAEU member states on the way to building a common market for pharmaceuticals

The 13th Annual Eurasian Economic Forum has kicked off today. Deputy Head for Cooperation with the EAEU of the Pharmaceutical Manufacturing Inspection Division of the FSI “SID&GP”, Ministry of Industry and Trade of Russia, Madina Sottaeva, spoke about the main algorithms of interaction between regulatory authorities and pharmaceutical manufacturers, during the session “Registration of medicines under the unified rules of the EAEU and inspection issues”.

 

 

Since 2022, all inspectorates of the member states of the Eurasian Economic Union have completely switched to the inspection procedure to meet the EAEU inspection rules. Both the regulators and the pharmaceutical industry have got a number of questions about pharmaceutical inspections, arising in the context of the full transition to the EAEU regulation.

In her speech, Madina Sottaeva, Deputy Head for Cooperation with the EAEU of the Pharmaceutical Manufacturing Inspection Division of the FSI “SID&GP”, Ministry of Industry and Trade of Russia, noted that now, in a difficult international situation, all the issues related to the drug availability and national drug safety, are vitally important.

Madina Sottaeva presented a review of the regulatory acts that affected the work of the GMP inspectorate and made it possible to avoid a shortage in the supply of medicines on the territory of the EAEU in the last two years.

First of all, that was about the Annex 2.1 to the Decision of the EEC Council dated November 3, 2016, which amended the rules for inspecting drug manufacturers for compliance with the Good Manufacturing Practice rules through remote means of interaction.

“Conducting remote inspections according to the EAEU rules enabled us not to stop the process of drug registration and also prevented a large shortage of medicines on the market,” Deputy Head for Cooperation with the EAEU of the Pharmaceutical Manufacturing Inspection Division of the FSI “SID&GP”, Ministry of Industry and Trade of Russia, Madina Sottaeva, said in her speech. – Taking into consideration the geopolitical situation prevailing in the world, we continue all our foreign GMP inspections in a remote mode, since February 28. As of February 25, since 2020 we have conducted 860 inspections, out of which more than 770 inspections were held in a remote mode.”

Madina Sottaeva also highlighted the fact that the norms and approaches in relation to a number of aspects still differ, e.g., there are differences in the consequences of non-compliance with the Rules of Good Practices, as well as in approaches to the requirements for the introduction of medicines into the market, drug movement monitoring systems, and maintaining unified databases of falsified and counterfeit products. Also, the regulators of the EAEU member states have not yet developed uniform requirements for the qualification and work experience of GMP inspectors.

In conclusion, Deputy Head for Interaction with the EAEU of the Pharmaceutical Manufacturing Inspection Division of the FSI “SID&GP”, Ministry of Industry and Trade of Russia, Madina Sottaeva, outlined a number of specific issues related to law enforcement and the uniformity of interpretation of the clauses of the EAEU legal acts by all the authorized bodies of the EAEU member states. She also advised all the involved parties to work together.

“We have something to work on and where to move forward to form a proper common market. It is necessary to tackle these tasks through the joint efforts of the authorized bodies of the EAEU member states, the Eurasian Commission and pharmaceutical manufacturers,” Madina Sottaeva said ending her speech.