Faster decision-making procedures and introduction of new medications to the market make the Eurasian pharmaceutical market more viable and favour its export potential
We see that our domestic industry is capable of producing almost the full range of essential medications: about 80% out of 809 items can be made in our country with a different rate of localization. We have learned to work and introduce medical products to the market. You probably remember decree 441, which upset many of our foreign partners and made many people in country blame us, calling it an experiment, and so on. However, we see that a lot of countries – almost all the countries – have chosen the fast-track way for introducing medications to the market — Victor Fisenko, First Deputy Minister of Health of the Russian Federation.
This is an unusual moment. The business community has come up with a whole range of initiatives that target increasing the capabilities when it comes to registration inspection. Many of them were included in the Eurasian Economic Union documents. Short and sweet: a registration portfolio may contain less paperwork, if one of the member states keeps them in the market. This is an extended opportunity for providing a national GMP certificate for registration purposes until 31 December 2024. This is an update of GMP rules that now include more approaches to production certification. Undoubtedly, another important trend is the use of remote procedures. It does not only concern drug circulation, but other types of regulation as well and has had a favourable impact on the time of laboratory inspections for registration purposes — Viktor Nazarenko, Member of the Board, Minister in charge of Technical Regulation, Eurasian Economic Commission.
We applaud to the most recent decisions of the Eurasian Commission that will help create competitive Eurasian regulations. Regulations that would keep up with national-level decision making – first of all, in the Russian Federation. To be honest, we were a bit sceptical at first, because we feared that national regulators may not have been making decisions fast enough. The Government of the Russian Federation has been leading and driving these processes. However, thanks to our discussion with the Eurasian Commission and the regulators of all the countries, the Commission has joined the processes promptly and has now become the driver <…>. The key to joint success is smart and harmonized regulations — Vladimir Shipkov, Executive Director, Association of International Pharmaceutical Manufacturers (AIPM).
Forum materials mentioned the outlook for the ‘Made in the EAEU’ brand. I would like to say that the EAEU norms are aligned with international rules. It concerns efficiency, quality, and safety. This is why the ‘Made in the EAEU’ brand is very promising, because these are the medications, the products that indeed comply with all the requirements. When it comes to our fast tracks, we have learned to introduce medical products to the market without compromising the quality. This is why the quality control system created earlier has proven its efficiency over the recent years. <…> Our country now boasts only high-quality, efficient, and safe medications, — Victor Fisenko, First Deputy Minister of Health of the Russian Federation.