Russia & EAEU Launch Common Regulated Pharma Market
The Eurasian Economic Union has ratified a regulatory framework for medicines circulation in the EAEU. According to Member of the Board – Minister of the Eurasian Economic Commission (EEC), Valery Koreshkov, “National medicines markets of the five Member States of the Eurasian Economic Union (EAEU) [will] unify and start operating in the format of a single space”. “Manufacturers of the Union countries will be able to apply for registration of medicines and their release under common procedures and reduce administrative costs.”
An average consumer will notice changes in the pharmaceutical market over time – it currently takes seven to ten months from the moment of filing a drug application for approval to releasing the drug into circulation and its sale. The new regulations will improve this administrative process once the drugs have been cleared for distribution.
The supranational regulations of the common market will be used for development, pre-clinical and clinical study, quality control, registration, manufacture, and distribution of medicines. “The Commission, together with the best experts from the five Member States of the EAEU, has prepared all the necessary documents for the effective operation of the common medicines market, taking into account global practice,” Valery Koreshkov said. “They are aimed at removing administrative barriers in manufacture and approval of medicines for circulation in the markets of the Union countries. These documents will also provide a distinctive “sanitization” of the pharmaceutical market, removing from it medicines, the efficacy and safety of which is not fully studied, but manufacture does not conform to the standards of good manufacturing practices.”
Matters related with the administration of approvals issued for preclinical and clinical studies of medicines, pricing of medicines and medical products, retail trade, public procurement of medicines, other procedures related to cost recovery in the circulation of medicines, and the regulation of medical advertising have been left at the level of national regulation.
A transitional period ensuring a smooth transition from national to common regulation is provided for. This will prevent bad performance of health systems in the EAEU countries, and help manufacturers of medicines to adapt to the new requirements as comfortably as possible. In particular, till December 31, 2020, the manufacturer has the right to choose under what regulations (national or common) it registers its medicines. All medicines registered under national regulations till December 31, 2020 should pass re-registration under the regulations of the common market before December 31, 2025. When filing a drug application for registration before December 31, 2018, the manufacturer may provide national documents issued by the Union Member States that confirm compliance of manufacture of medicines with the requirements of national GMP instead of a GMP certificate of the EAEU.
“These new regulations have implications for foreign drug manufacturers” says Chris Devonshire-Ellis of Dezan Shira & Associates. Indian drug companies should especially take note, as well as the Chinese TCM market as both these countries are negotiating to have Free Trade Agreements with the EAEU. Now is a good time to be analyzing this market and preparing for the new opportunities that the standardization of EAEU Pharmaceuticals industry will bring”
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