August 10th 2014
Order no.152н of the Ministry of Healthcare of Russia as of 03.04.2014. "On introducing amendments to certain orders of the Ministry of Healthcare and Social Development of the Russian Federation and the Ministry of Healthcare of the Russian Federation" was published by the "Rossiyskaya Gazeta", and registered by the Ministry of Justice of the Russian Federation as of 10 June 2014 under registration number: 32648.
The introduced amendments concern the expert appraisal and drug registration in Russia. Thus, order No.750н of the Ministry of Healthcare and Social Development as of 26.08.2010. "On the approval of regulations for expert appraisal of drugs and the forms used by expert commissions to document their conclusions".
The update includes an amendment stating that during an expert appraisal procedure, it is forbidden to withdraw any document necessary for the implementation of the procedure.
In case the is a document lacking from the submission which is necessary for the specialist to issue of conclusion, the administration of the expert agency shall form a request for the submission of all necessary documents and send this request to the Ministry.
The period of materials consideration, and the consideration procedure for drug registration in Russia shall be regulated by additions and updates in the Administrative policy of the Ministry of Healthcare of the Russian Federation for the provision of federal drug registration services, as defined by order No.428н of the Ministry of Healthcare of the Russian Federation as of 22.10.2012.
Misunderstandings between the regulating bodies creates obstructions in the registration process of new foreign pharmaceuticals
March 18th 2016
The participants of the Third Practical Conference "Launching New Pharmaceuticals in Russia and CIS" concluded that foreign pharmaceuticals will not be registered in Russia by the end of 2016.
According to Herman Inozemtsev (the editor of the journal "Pharmatsevticheskiy Vestnik"), the FAS, Ministry of Healthcare and MIT form the so-called regulatory triangle, and take decisions and create documents in such a flexible manner that they can both disappear and reappear.
On December 2014, following the review of FL No.61 "On Drug Circulation", a conclusion was made for the need of a Russian inspectorate certificate during the filing of a GMP registration certificate.
This period is delayed for most enterprises, since the RF government requires drug production sites to pass the GMP inspection. There are complex pharmaceuticals produced by eight different plants working together.
GMP requirements in the Russian Federation are similar to European requirements. And no problems shall arise in this case. Pharmaceutical companies are concerned with the above-mentioned triangle and are worried there may be discrepancies between the law on paper and what happens in practice during its implementation. For example, there was a dispute between the FAS and the Ministry of Healthcare when the regulatory bodies interpreted the same document in different ways.
This is the reason why the pharmaceutical sector is looking forward to the common drug market of the Eurasian Economic Community. Although transition to this market is associated with many problems for pharmaceutical companies, such as the preparation of many master files in compliance with the requirements of the Eurasian Economic Community. But after approval of the latest documents, as well as drug registration provisions, firms received the opportunity to defeat in the current situation in the Russian Federation.