Convergence of the EU and EAEU pharmacopoeia is key to barrier-free market for quality medicines

_ EEC. Moscow, 28 April 2018.

The citizens of the European Union and the Eurasian Economic Union (EAEU) should be provided with quality, effective and safe medicines at acceptable prices, and pharmaceutical companies of these two Unions should be competitive on the world market. The Member of the Board – Minister of the Eurasian Economic Commission (EEC) Valery Koreshkov told about these common tasks and the need to establish cooperation in the sphere of pharmaceutical market regulation of the continent during the international seminar “Regional pharmaceutical markets of the EU and the EAEU – general trends, regulation and challenges” held in Brussels.

The event, which was attended by the representatives of the pharmaceutical community as well as regulatory authorities from the European and Eurasian Economic Union countries, was organized by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Association of International Pharmaceutical Manufacturers (AIPM).

The EEC Minister shared his experience with the European colleagues, reporting on how the Eurasian Economic Commission solves the current problems. “When developing instruments to operate common pharmaceutical market in the EAEU, we have studied and applied best international practices, – Valery Koreshkov pointed out at the Panel session moderated by Nathalie Moll, Director General of the EFPIA. – We took into account the experience of leading experts from international organizations, regulatory authorities and the pharmaceutical industry. This allowed creating, within short timeframes, a large-scale supranational regulatory framework.”

The EEC Minister paid special attention to the direct effect of the EEC decisions in all countries of the Eurasian Economic Union. According to Valery Koreshkov, the EAEU States have recently confirmed their readiness to implement two procedures – registration under the procedure of mutual recognition and harmonization of a registration file of already registered pharmaceuticals with the Union law. In 2018, an active work began on registration of medicines using single rules. By now, the issue on GMP-inspections conducted according to the Union rules has been addressed in full: a pharmaceutical manufacturer, for example, may send an application to any of the inspectorates of the EAEU Member States, regardless of their territorial location.

When speaking about the objectives of the Commission, Valery Koreshkov stressed that the EEC is seeking the same freedom of movement of high-quality medicines, which meet the needs of health protection and international trade, as in the European Union. This should be helped by the use of the European experience, widespread introduction in the EAEU of the risk-based approach, including in the implementation of the GMP-inspection procedure, optimization of control functions, etc.

Valery Koreshkov also met with the representative of the European Directorate for Quality of Medicines and Healthcare (EDQM), Emmanuelle Charton, with whom he discussed the Draft Memorandum of Understanding to be signed as well as issues of further cooperation between the EEC and the EDQM. Let us remind that the agreement for signing the document had been reached earlier by the EEC Minister and the EDQM Director Susanne Keitel during their previous talks.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) brings together the representatives of the pharmaceutical industry of the EU countries. EFPIA comprises 33 national associations and 39 leading pharmaceutical companies. Thus, the Association cooperates with the European Medicines Agency (EMA) and represents the interests of more than 2,000 companies in the EU, specializing in research and development as well as the introduction of modern medicines to the market, which makes a significant contribution to improving the health and quality of life of patients around the world.

The Association of International Pharmaceutical Manufacturers (AIPM) was established in 1994 and represents on the territory of the Russian Federation the interests of leading international pharmaceutical companies – manufacturers and developers of modern efficient, safe and quality pharmaceuticals in cooperation with federal executive authorities. Nowadays the AIPM unites more than 60 international companies, which account for more than 80% of global pharmaceutical production and more than 60% of medicines supplied to Russia.

The European Directorate for the Quality of Medicines and HealthCare (EDQM) was founded in 1996 under the auspices of the Council of Europe as part of the implementation of the provisions of the Convention on the Elaboration of a European Pharmacopoeia 1964. The main objective of the EDQM is to ensure the quality and availability of medicines and medical care, the development and revision of the European Pharmacopoeia. The European Pharmacopoeia was signed by 38 participants: the Member States of the Council of Europe and the European Union. Some 30 States participate in the EDQM as observers, including Armenia, Belarus, Kazakhstan and Russia.


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