Tuesday, September 26 2017 13:34
Alexandr Avanesov

The regulatory documents of the EEMP for medicines include about 70% of business proposals

ArmInfo. The development of a single drug market in the Eurasian Economic Union (EAGE), launched in May this year, and the provision of safe, effective and high-quality medicines to allied countries require synergy between national pharmaceutical enterprises and effective communication policies at all levels. Of particular importance, according to Oksana Plashkova, Deputy Director of the Department for Technical Regulation and Accreditation of the Eurasian Economic Commission (ECE), has the organization of business interaction with regulatory and supervisory authorities. "About 70% of the proposals that came from the representatives of the pharmaceutical community to the Commission were included in the normative acts regulating the unified drug market of the EAEC," Oksana Plashkova emphasized.

During the working meeting of the representatives of ECE and a number of leading pharmaceutical companies that are members of the Russian Union of Professional Pharmaceutical Organizations, it was noted that effective interaction of the Commission with business and national regulators allowed creating a balanced system of supranational regulation of medicines with clear and transparent rules.  "The agreement on common principles and rules for the circulation of medicines within the framework of the EAEC and all the main acts of the Commission aimed at its implementation have been adopted and entered into force," Oksana Plashkova noted.

At the same time, transitional periods are provided ensuring a smooth transition from national to unified regulation. In particular, until December 31, 2020, the manufacturer has the right to choose by which rules (national or uniform) he will register medicines. All medicines that have been registered under national regulations before December 31, 2020, must be re-registered under the rules of the single market until December 31, 2025. When submitting a dossier for drug registration until December 31, 2018, the manufacturer is entitled to provide, in place of the EAEC GMP certificate, national documents issued by the member states of the Union and confirming the conformity of its production with the requirements of the national GMP rules. This will help manufacturers of medicines to adapt to new requirements as comfortably as possible.  The regulators of the general market of medicines face an important task - to create optimal conditions for their production in the EAE, which will allow manufacturers to work in the conditions of proper practices, thus ensuring the introduction of advanced technologies and modern standards of treatment.

One of the goals of the working meeting was the awarding of the ECE Prize to the winner of the Eurasian Communications-2017 competition, which the Commission organized jointly with the Business Council of the Eurasian Economic Union and the Russian Public Relations Association. In the nomination "Single Market of Medicines", Bayer AG won the victory. The pharmaceutical company presented a project systematically combining the issues of launching new drugs in the unified market of the Union and the strategy of information support of this process, including the development of multimedia products, the creation of a common package for the countries of the Union for Packaging Design, taking into account the linguistic diversity and the requirements of the standards and technical standards of the EAPS. The creation of a unified communication platform and the development of a new business model for interaction with consumers and regulatory agencies of the EEA countries became one of the key arguments for awarding the company the first place in the nomination.  

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