Russian trial approvals up in 2011, but reviews still slow says ACTO

30-Jan-2012 - Last updated on 30-Jan-2012 at 13:51 GMT

Russia’s trial sector has largely recovered from the ‘crisis’ created by revision of approval system in 2010, but regulators are still taking too long to OK studies says industry group ACTO.

According to report by the Moscow-based Association of Clinical Trial Organisation’s (ACTO) the Russian Ministry of Health (MoH) approved 567 studies in 2011, 17.6 per cent up on the previous year, with a record 370 international multicentre clinical trials (IMCT) being given the green light.

This is a significant improvement on the 246 IMCTs OKed in 2010 when – according to ACTO and others – the MoH’s failure to devote sufficient resources to reviewing applications and legal problems related to the importation of supplies severely hindered the approvals process.

“In analysing the results of 2011 we can conclude that crisis of 2010, created by the reorganisation of the regulatory approval system and transfer of approval authority from Roszdravnadzor to the Health Ministry, has been overcome.

“We believe that the good results for IMCTs are a result of the hard work of the clinical trials department at the Health Ministry.”

Registrational studies

ACTO also noted an increase in the number of foreign-sponsored, bioequivalence studies approved in 2011, which it attributed to the requirement – introduced in the ‘On Circulation of Medicines’ law – that generic drugs are tested in Russia before they are approved.

This growth in bioequivalence studies was not matched by foreign-sponsored, local trials of innovative drugs – also required under the new laws – 35 of which were approved in 2011, which is just four more than in 2010.

However, ACTO – whose members include international and Russian Pharmas and CROs – believes “this may be due to the fact that it is more difficult to commence such type of trial and more expensive to conduct."

The organisation also suggests that the relative complexity of such trials – compared with studies for generics – is behind the 35 per cent decline in the number of registrational trials conducted by Russian drugmakers.

“It is possible that this decline is the result of the new law’s intent to build local trials into the registration system, as now it is only possible to commence such trials if you have already launched the registration process.”

Negatives

But – despite welcoming the progress made in 2011 – ACTO still has some concerns about the oversight of the Russian trials sector.

Foremost among these is the time it takes to review applications, which ACTO said has increased under the MoH’s stewardship and is often twice that set out in the statutes.

“The timeframe for issuing approvals is a traditionally difficult issue in Russia. Waiting times were unsatisfactory under Roszdravnadzor, but according to results of six months of monitoring by ACTO, the Health Ministry has managed to perform even worse, bringing down the waiting time by 30.5 per cent.”

ACTO believes that adopting regulations that clearly specifying timelines for carrying out all internal procedures and sticking to them would help CROs and sponsors alike.

It also said that removing the ‘absurd’ requirement to re-file documents – created by the fact that approval for registrational trials and IMCTs are covered by two different procedures - would accelerate the process significantly.

The organisation explained that – under current laws - if a trial is carried out as part of a drug registration process expert review is conducted before the submission of a study application, whereas for IMCTs review is conducted after submission.

This means – According to ACTO that for IMCT trials “after announcing the results of the expert examination, the applicant is forced to re-file the application to conduct clinical trial. This increases the already quite significant waiting times for approval by another 3—4 weeks.”

The MoH did not respond to request for comment ahead of publication.