On November 15, 2017 the Scientific and Practical International Conference “Common market of medicines within the Eurasian Economic Union - modern trends of medicinal products regulation and enforcement”, unprecedented by its participants, content and discussion on high professional level, was held in Moscow. The Conference gathered high-ranking representatives of the Eurasian Economic Commission (EEC), the European Directorate for the Quality of Medicines (EDQM), the European Medicines Agency (EMA), EAEU Pharmacopoeia Committee, regulatory authorities and expert agencies of all EAEU Member-States, heads of the leading national and international professional associations, industry. The event was organized by the Eurasian Economic Commission (EEC), the Association of International Pharmaceutical Manufacturers (AIPM) and the European Federation of Pharmaceutical Industry and Associations (EFPIA).
The Regulatory Workshop program comprised of different work formats, including plenary sessions and the round-table meeting attended by more than 250 representatives of the pharmaceutical community, the videoconference with EMA’s headquarter and regulators’ professional dialog.
Vladimir Shipkov, AIPM Executive Director, acting as the plenary session moderator, noted at the Conference opening that the event was intended to discuss the current worldwide regulatory trends, to enhance the supervisory functions and to provide the necessary quality of medicines based on the comprehensive risk - oriented approach, in particular, during GMP inspections. “We see that the EEC greatly contributes to regional integration and harmonization, bearing in mind the contemporary global practices in regulatory science. A harmonized and coordinated approach to enforcement is extremely important at the current stage, after introduction of the Union’s rules and procedures,” emphasized Vladimir Shipkov.
Valery Koreshkov, a Member of the Board – Minister in charge of Technical Regulation of the Eurasian Economic Commission, covered the particular features of EAEU’s adopted good practices, the current progress in developing “3rd level” documents, and the transition periods envisaged in EAEU’s acts, when delivering his main speech titled “Formation of a common market of the medicines within the framework of the Eurasian Economic Union”.
The Minister drew the attention to the direct legal effect of the EEC’s acts in the territory of all of the EAEU Member-States: “The Parties have confirmed they have prepared to implement two procedures: registration under the mutual recognition procedure and aligning the registration dossier for registered medicines with the Union’s law. The large-scale registration using the Union’s single information system will begin after its launch late in 2017.” Besides, Valery Koreshkov emphasized that the issue of GMP inspections based on the Union’s rules had been finalized, and any manufacturer could apply to any inspectorate of the EAEU Member-States, notwithstanding its location.
Arman Shakkaliev, Director of Technical Regulation and Accreditation Department of the Eurasian Economic Commission, highlighted the cross-country interaction tools in the Union and the procedure for settling disputes arising from registration of medicines, as provided in EAEU law. “The backbone of relations between EAEU countries, like central nervous system, is the Union’s single information system. It comprises three components: EEC’s integration segment that is completed; the integrated system between the national operator and the competent authority that undergoes intensive testing and, finally, the section between the competent national body and the user (applicant), which is in full responsibility of EAEU Member - States,” told Arman Shakkaliev.
The experience gained by the European Union in building up the single IT system in regulation of medicinal products and in arranging for coordination between the member states was presented by Radhouane Cherif, Head of the Telematics Office of the European Medicines Agency (EMA).
The reports by Elena Sakanyan, Chairman of the EAEU Pharmacopoeia Committee, and Cathie Vielle, Head of the European Pharmacopoeia Department, European Directorate for the Quality of Medicines (EDQM), were focused on the role and place of EAEU and EU Pharmacopoeia in regional integration and harmonization.
A fruitful and constructive discussion was held concerning the narrow specialized but very important topical issue for the Russian regulatory system – the alternative use of in vitro methods and the assessment of the quality assurance system as a modern alternative to animal tests, in particular, the abnormal toxicity test that is not required anymore in the overwhelming majority of countries, or revised by the authorities for a number of medicine categories, as the medicinal product quality is mostly guaranteed by a set of quality control and assurance measures and more advanced analytical approaches. The need for harmonization and convergence of regulatory approaches in view of the modern globalized production cycle was strongly proved by Angelika Joos and Dr. William M. Breken, representatives of the European Federation of Pharmaceutical Industry and Associations.
In general, the Regulatory Workshop was highly appreciated by participants who expressed willingness to conduct such discussions on a regular basis.
The Conference presentations and photos are available following the links:
The Association of International Pharmaceutical Manufacturers (AIPM) was established in 1994 and represents in the Russian Federation the leading international pharmaceutical companies - producers and developers of modern effective, safe and high-quality medicines. Today, AIPM unites more than 60 international companies that provide over 80% of the world’s pharmaceutical products and over 60% of medicines imported to the Russian Federation.
For additional information, please contact:
Irina Sheykkha, Legal and Communications Director, AIPM
+7 (495) 933 70 40, I.Sheykkha@aipm.org
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