Federal Anti-Monopoly Service proposed cancellation of additional clinical trials of drugs that have been registered in Europe and USA

Дата публикации: 26 january 2016

The non-profit partnership ‘The Healthy Future’ published an article “Federal Anti-Monopoly Service suggested to recognize results of clinical trials of drugs registered by FDA and EMA” with the comments of Sofia Demura, Medical Director, Aston Group.

“Today, depending on the complexity of clinical trials, it takes from 3 to 5 years to issue market authorization for a foreign pharmaceutical in Russia” – Sofia Demura explains. – “It is well-known that  registration takes a lot of time and is quite expensive. Ultimately, it affects the end consumer price.

FDA and EMA originated the development of guidelines on GMP and GCP* (the standards followed by the global community of health care professionals), that have been regulating the effectiveness and safety of drug use in Europe and the USA for several decades.

I believe that simplified registration is a step forward towards better availability of medications and improvement of clinical outcomes. Moreover, the lower registration costs will positively impact the consumer prices.”