5 Сентября 2016
01 сентября ведущее западное издание о клинических исследованиях CenterWatch опубликовало в своем ежемесячном выпуске колонку генерального
директора ОСТ Дмитрия Шарова о важности российского региона для международных
ОСТ публикует оригинальный текст.
In the last 20 years, Russia has seen an increasing growth of the clinical trials industry. Among the factors contributing to that are top-grade research facilities, vast and easy-to-access populations and low participation costs. Over the past two years, significant changes have occurred in this market that are likely to have a global impact. All recent legislative efforts were aimed at harmonizing the local regulatory requirements with international standards and pharmacovigilance procedures. Clinical trials in Russia undergo regular FDA inspections and are among one of the world’s best in terms of quality, exceeding Western countries.
In the light of these changes, Russia is now seen also as a gateway to the market of the Eurasian Economic Union (EEU) for international companies. The EEU and EU legislations are very similar. The EEU pharmaceutical registration procedure requires the submission of the following clinical trial reports:
- Clinical trials conducted in ICH regions or within the EEU before January 1, 2016.
- Clinical trials conducted in one or all EEU member states in compliance with applicable EEU regulations after January 1, 2016.
These requirements make a company’s GCP/ compliance, audit results and general experience particularly important criteria in the selection of CROs. Nevertheless, there are many issues that still require clarification. This, however, gives pharmaceutical companies the needed breathing space to make all the necessary preparations for the new procedure.
Global market research shows that in 2015, the share of international multicenter clinical trials did not change as compared to the previous period, and amounts to about 38%. Having become the stepping stone for entering into new markets, Russia is expected to raise even more interest from international pharmaceutical companies as the most important region for international multicenter clinical trials.