The year 2024 marks the 10th anniversary of the functioning of the common pharmaceutical market in the territory of the Eurasian Economic Union. At the same time, some of the issues of governing medicinal products are enshrined at the level of the legislation of the member states, and some are regulated by supranational legislation. Ten years might seem a significant period for the formation of the common market, but pharmaceutical manufacturers still wonder what the common market is, what problems exist in it and if they can be solved.

The current topics of the pharmaceutical industry concern will be covered at “Ten Years of the EAEU Common Pharmaceutical Market” session as part of the 9th Pan-Russian GMP Conference with international engagement.

The issue of mutual recognition has been repeatedly discussed, including at the GMP conference, but the industry still comes up against situations where a GMP certificate is not recognized in another EAEU member state. Such examples raise questions and lack of understanding on the part of participants in the common market: if the principle of mutual recognition is declared, why are GMP certificates issued by the Russian Federation not recognized in other member states, why do manufacturers have to undergo repeated GMP inspections for marketing authorization of a medicinal product even under national legislation.

Another area of ​​concern for the pharmaceutical industry is inspections as part of registration procedures: applicants often do not know who is to initiate them, how and when they are to undergo the inspection. Regulations do not clearly describe the procedure, and conscientious manufacturers shall be aware that this lies with their area of ​​responsibility.

On August 22, 2024, during the discussion of issues that still concern pharmaceutical manufacturers at “Ten Years of the EAEU Common Pharmaceutical Market” session partnered with Promomed Group, regulators of the Union member countries will provide clarifications on the following:

• certain transitional stages on the way from national to supranational regulation in terms of registration of medicinal products and pharmaceutical inspections and temporary measures to establish features of the circulation of medicinal products for human use;
• mutual recognition of results of GxP production inspections between the EAEU member states and its current state;
• inspections as part of registration procedures, interaction of the process participants.

The GMP conference hosts invite company representatives to take part in a survey on Telegram channel PRO GMP. Vote for the most relevant topics, or ask your question in the comments.

The survey is open until August 13 at https://t.me/progmp/325

Event organizers: Ministry of Industry and Trade of the Russian Federation and the State Institute of Drugs and Good Practices (SID & GP), the Conference’s operator is the Corporate Communications Center S-GROUP