More than 60 pharmaceutical organizations headed by the Minister of Technical Regulation of the Eurasian Economic Commission Victor Nazarenko the other day discussed a number of issues related to the single pharmaceutical market of the Union.

In particular, they discussed the transition of medicines to common rules of the EAEC, the development of digital formats, cooperation, and expanding the capabilities of the information system, as well as the need to respect intellectual property rights and protect the exclusivity of clinical trial data (“data exclusivity”).

“Predictability of regulation of the common market of medicines of the Union and transparency of regulatory decisions are the main principles of the Commission’s activity in this area”, – stressed V. Nazarenko, EEC Minister at the meeting.

He also noted that the Commission closely cooperates with both authorized state agencies and representatives of pharmaceutical business in the circulation of medicines. In this regard it is noteworthy that more than half of the working group to form unified approaches to regulating the circulation of medicines are these entrepreneurs. They are also included in the working group to assess regulatory compliance.

Practical proposals for improvement of normative legal acts are made by representatives of the business segment in the course of public discussions of documents posted on the legal portal of the Union:

Representatives of international pharmaceutical companies found it possible to create a single EEC regulator in the format of the European Medicines Agency (EMA, European Medicines Agency).

According to the EMA experts, the Eurasian Medicines Agency would be able to help solve the problems of leading drugs that arise when they enter the market, ease the administrative burden on business and consolidate the expert resources of the countries, reducing the additional work that is spent on expertise, eliminating the expertise on the carrier, as well as ensuring proper factory quality of medicines.

Victor Nazarenko assured the manufacturers and entrepreneurs that if there are proposals to optimize the legislation of the Union (which in turn will not increase the risks of quality, safety and efficacy of circulating drugs), the Commission is ready to organize discussions with the authorized bodies of the EEU states.

In this connection the block of those regulations of EEC plans to continue meetings and discussions with pharmaceutical organizations and experts.

hetq.am