At a recent conference I attended, dedicated to the regulatory affairs in Russia, CIS, and Turkey, the overriding message from pharma company representatives (in terms of registering their products in Russia) was concern about the lack of clarity and “vagueness” of law defining the country’s drug registration process. There was much anticipation in relation to the amendments to the federal law, FZ:61 “On Drug Circulation” due within the next few weeks.
The eagerly awaited draft amendments to the federal law, as well as Article 333.32.1, part two of the tax code of the Russian Federation, were published for consultation by the country’s Ministry of Health in late January this year. The amendments proved to be a mixed bag.
Proposed changes
So, what are some of the proposals within the amendments? Apart from the definitions of terminology such as pharmaceutical substances, orphan drugs, biological drugs, reproduced drugs, reference drugs, bioanalogues, interchangeable drugs, and bioequivalence studies, the draft amendments also include:
· Accelerated registration for orphan drugs and newly registered generics. This accelerated procedure will not be applicable to biosimilars, originator drugs (except orphan drugs), generic drugs (except newly registered ones), new combinations of previously registered drugs, and medicines that were registered earlier but produced in other dosage forms.
· Local clinical trials. While, local clinical trials will still be necessary, for orphan drugs “the results of preclinical and clinical studies performed outside of the Russian Federation in accordance with the rules of good laboratory practice and good clinical practice will be recognised”.
· Expertise for carrying out clinical studies. Additionally, the document proposes the requirement to obtain a “permit to import a particular consignment of unregistered medicines for the pharmaceutical examination of samples” in order to receive approval for an international multicentre clinical trial or post-registration clinical trial of a drug. Also, a document confirming “payment of state fees for the ethical review, examination of documents and examination of samples of pharmaceutical drug to get approval for an international multicentre clinical trial of the medicinal product for medical use, or a document confirming payment of state fees for the ethical review of examination papers and pharmaceutical examination of samples of the drug to get the permission for a post-registration clinical trial of the drug for medical use” will be required.
Implications of the amendments
Certain changes would potentially be a welcome development for the pharma industry and pharmaceutical manufacturers. For example, the need for clarification of terminology has been alluded to on several occasions by Russia’s Federal Antimonopoly Service (FAS). Furthermore, the accelerated registration process for orphan drugs and in particular, the recognition of results of preclinical and clinical trials performed outside Russia is a positive development for orphan drug manufacturers given the challenges posed by conducting domestic clinical trials–considering the limited patient population for rare conditions.
In terms of an accelerated process for “newly registered generics” the regulations could potentially encourage faster access of generics to the market once the originator drug comes off patent.
The proposals for a permit to import a particular batch of unregistered medicines, a fee to be paid for ethical review and examination of documents and samples may, on the other hand, be a negative development. This requirement, if approved, could make the registration process even lengthier and more complex – not to mention the potential increased expense for pharmaceutical companies.
What to expect next…
The public consultation for the draft document is expected to continue until 23 March. However, as of now, several suggestions have been proposed by the FAS–as well as other organisations and industry associations. The MoH has stated that it is expecting to introduce changes to over 40 articles within the pharmaceutical law. The changes will be related to areas such as registration of biologics and bioanalogues, interchangeability of medicines as well as introducing the possibility to “pause/freeze” the registration process, and differentiated requirements for “expertise” for different drug categories.
It remains to be seen whether further clarifications and specifics will be introduced to the registration legislation–and what these will mean for the pharma industry.
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