Bioequivalence and Bioavailability Forum

• AFAIK most (all?) Russians CROs are closely related to clinics / University hospitals. Have you ever talked to a professor in a (Western-)European hospital? GCP? Gods in white coats over here as well.
  
• GLP was introduced in the US in the late 1970s and by OECD in the 1980s. In Russia still in the nursery. That’s a fact.
  
• Language barrier. At a conference last year in Moscow simultaneous translation was provided since ~90% of attendees didn’t speak English at all. If you want to inititate business in Russia you have to be fluent in Russian. Even if the management of CROs knows English, you cannot assume the same for the personnel – and you want to talk to them during site visits. Methods/SOPs are in Russian. Then the usual story if you meet somebody with limited knowledge of English. Most will not tell you that they didn’t understand your question and – if in doubt – answer “yes” rather than “no”.
  BTW, in Japan “yes” (by definition!) means “Yes, I understood your question” even if the answer should be “no”. Example: The CRO doesn’t have an archive. “Do you have an archive?” – “Yes.”
  Expect similar issues in Russia.
  
• National pride. Without the support of the Russian space agency, the IIS should have been shut down years ago. Russia considers itself a superpower – not a developing country. Easily innocent questions are judged as Western arrogance or interpreted as a hostile interrogation.
  
• …

❝ Russia is a very big and interesting market. Guess why so few generic companies try to enter this market.

  In 2012 the Ministry of health issued 915 approvals to conduct clinical trials, which is more than 60% excess over the 2011 rate. This was also an absolute record for the entire period of keeping records.
  The significant growth in the number of approvals issued was primarily due to a real boom in bioequivalence studies. The number of this kind of studies of foreign medicines increased by a factor of nearly six, totalling 107 approvals set against just 19 in 2011.
  An analysis of the local efficacy and safety trials sector revealed that the majority of the trials were those of generics. On the whole it can be concluded that the Russian market for clinical trials previously indisputably innovative, has over the course of one year veered sharply towards generics. In our opinion, these structural changes on the market are the result of the law “On Circulation of Medicines” passed in 2010.

The Legal Department of the Ministry of Health and Social Development (MHSD) has no English translations of the relevant legislative documents available, nor does it certify/approve translations. Consequently, the experts retrieved English translations from the Internet, in particular from the website of the Association of Clinical Trial Organisations (ACTO).