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AIPM supports the possible creation of a single regulator in the EAEU

“The predictability of regulation of the common market for drugs of the Union (note - the EAEU) and transparency of regulatory decision-making are one of the basic principles of the Commission (note - the Eurasian Economic Commission) in this area," said Minister for Technical Regulation of the EEC Viktor Nazarenko within the framework of a working meeting with the leadership of international pharmaceutical companies (members of the Association of International Pharmaceutical Manufacturers - AIPM).

In this context, Viktor Nazarenko discussed with the representatives of the association, which unites more than 60 international companies, a number of topical issues on improving the common market for drugs in the Union. In particular, the issues of transition to uniform rules for registration of medicines in accordance with the Union law, the development of digital formats and interaction procedures, the expansion of the information system's capabilities, the need to comply with intellectual property rights and the protection of the exclusivity of clinical trials data ("data exclusivity") were considered.

At the same time, Viktor Nazarenko noted that the Commission works closely with both authorized government agencies and representatives of the pharmaceutical business on the circulation of medicines. From this point of view, it is indicative, for example, that about half of the members of the working group of the Commission on the formation of common approaches to regulating the circulation of medicines in the EAEU are entrepreneurs. They are also part of the regulatory impact assessment working group. Practical proposals for improving the draft EEC normative acts come from business in the course of public discussions of documents that are posted on the Union's legal portal.

Representatives of international pharmaceutical companies - members of the Association of International Pharmaceutical Manufacturers at the working meeting supported the possible creation of a single regulator in the EAEU on the principle of the European Medicines Agency (EMA).

Recall that recently this idea was announced at the St. Petersburg Economic Forum by the Chairman of the EEC Board Mikhail Myasnikovich. According to experts and business representatives, the Eurasian Medical Agency would help solve the problems of optimizing the launch of advanced drugs to the market, reduce the administrative burden on business and consolidate the expert resources of countries by eliminating duplication of work on examination, inspection of production sites and ensuring the pharmacopoeial quality of drugs.

The moderator of the meeting, AIPM Executive Director Vladimir Shipkov thanked the Commission for the great work it is doing to develop the common drug market. On behalf of the association, he also expressed confidence in the further continuation of the promotion of Eurasian integration within the powers and expertise of manufacturers, relying in their proposals on their own and international experience.

Viktor Nazarenko assured the industry representatives that if there are any proposals to optimize the Union's law, regulatory procedures (undoubtedly, without increasing risks to the quality, safety and efficacy of drugs being circulated), if specific editions of the proposed regulations and norms are provided, the Commission is ready to organize their detailed and prompt discussion with the authorized bodies of the EAEU states at their site. The meeting participants noted the constructive nature of the discussion of complex issues arising from the industry and regulators.

In this regard, the block on technical regulation of the Commission plans to continue holding working meetings with representatives of pharmaceutical companies and the expert community.

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