Pitfalls on the way to a single EAEU market, says Russian trade group

2020 was the year of bringing the drug dossier in correspondence with the unified rules of the Eurasian Economic Union (EAEU), but the COVID-19 pandemic intervened in this process. This will now be a feature of the Russian pharmaceutical industry: continuation of the dialogue" meeting on October 27, the Association of the Russian Pharmaceutical Products (ARFP/ARPM) says.

From January 2021, pharmaceutical manufacturers will have to register their products only in accordance with union requirements. And by 2025, the rules for the production and sale of pharmaceuticals and medical devices should be fully unified on the territory of Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan. However, a number of the Union states have taken the initiative to keep the national drug registration systems in force in parallel with the Union's norms and to postpone the transition period for two years.

“These proposals must have a serious justification with an indication of the work plan. But, I think that there was enough time for preparation, emphasized Victor Dmitriev, general director of the Association of Russian Pharmaceutical Manufacturers. Maintaining a dual system is a big burden on both the regulator and the business, he noted.

The single pharmaceutical market will reduce barriers associated with the specifics of national pharmaceutical markets, significantly increase the quality, safety and effectiveness of drugs, and most importantly, accessibility for the population of the participating countries.

To date, pharmaceutical companies in five countries are actively registering drugs under new rules, bringing the portfolio's registration dossiers in correspondence with the established requirements. More than 80 drugs have already received registration certificates according to the rules of the EAEU. About 400 dossiers are under examination, of which 310 are in the Russian Federation. Registration is very intensive, technical problems arise with a single integrated information system. Its throughput is much lower than the volume of documents provided at present.