Russia has the shortest period of drug registration to date

| By | Drug Registration

This was announced by the Minister of Health the Russian Federation, Veronika Skvortsova, at an expanded meeting of the State Duma Committee on Health Protection.

“Since 2012, there was a five-time decrease in the number of refusals to register drugs (from 51% to 10%). When compared to developed systems in other countries, we now have the shortest period of registration of about five months (110 working days). In Europe, the similar period is seven months while, in the US, it takes 10 months,” said Mrs. Skvortsova.

Over the past six years, we registered more than 200 thousand Russian medicinal products that meet the quality and safety criteria, added the Minister. Their share in the total number of registered drugs increased from 61% in 2012 to 84% in 2017.

“Our pharmaceutical market is growing every year. In the past year, it grew by 8% compared to the previous year. These are 6.3 billion packages of medicinal products worth 1.6 trillion rubles,” said the Minister.

In addition, Russia is elaborating the mechanism for accelerated registration of innovative drugs (no more than 60 working days for individual drugs).

Mrs. Skvortsova noted that, in recent years, the regulation of this sphere made a significant progress at all stages. She added that almost 90% of medicines are fully manufactured in the Russian Federation.

“87% of Russian medicines are fully manufactured in our territory. This means full-cycle manufacturing starting either from the creation of substance or finished dosage form,” said the Minister.