Russia's Federal Antimonopoly Service is planning to introduce amendments to the drug circulation law that includes controversial changes to the generics registration procedure.
IHS Global Insight Perspective | |
Significance | Russia's Federal Antimonopoly Service (FAS) intends to introduce changes to federal law N 61 "On dug circulation", aimed at simplifying application and registration procedures. |
Implications | Although the amendments include changes to the application process for clinical trials aimed at removing the current "repeat" in some of the procedures, the changes also include a controversial proposal to simplify the procedure for generic registration whereby "a simplified procedure would be to not conduct bioequivalence". |
Outlook | Although the suggested changes to make the registration and application process more transparent and less "repetitive" are a welcome development for the pharma industry, the proposed change for a simplified registration of generics indicated by Yulia Ermakova of the FAS is not likely to be approved. |
Russia's Federal Antimonopoly Service (FAS) intends to introduce amendments to the law "On drug circulation", reports Rossiyskaya Gazeta. The announcement of the proposed changes was made by the deputy head of the FAS's Department on Social Sphere and Trade Control, Yulia Ermakova, at the "pharmaceutical business" Conference. The proposed changes are available, in Russian, here.
Generic and Orphan Drugs
The proposed amendments include changes to the registration process for orphan and generic drugs. The FAS proposes that rather than making the registration process for these drugs faster, it should be simplified instead. Thus, as stipulated by Ermakova, "accelerated procedure" implies that the applicant has to provide the same amount of documents required for regular registration, but only the timeframes are reduced, while under a "simplified procedure", the applicant would have to provide fewer documents, thereby making it not only easier for the applicant but also reducing the processing time.
Specifically, for generics, a "simplified procedure would be to not conduct bioequivalence". According to Ermakova, this is because "the original product has already passed such a procedure, which means it is not necessary for generics to conduct these. In addition, the procedure for bioequivalence significantly increases the cost of the final product". The FAS further plans to prepare a separate paragraph on the registration process for orphan drugs by taking into account "international experience".
Requirement for Local Trials Cancelled, and Other Changes
In addition to the above, the FAS also intends to cancel the requirement for the need for repeated local clinical trials and bioequivalence studies in Russia if the drug already has research results from trials that were held in accordance with international requirements.
Among the other amendments included in the proposed changes are ones related to obtaining approval for conducting clinical trials. The changes are aimed at removing some of the repeated and contradictory procedures, thereby making the process quicker. The FAS further proposes the cancellation of the "five-year term of the registration certificate" and implementation of a permanent registration certificate, as well as "strengthening" the obligation of the Ministry of Health to post the entire registration procedure on its website.
Outlook and Implications
Although some of the changes such as making the application procedure less repetitive and making the registration process more transparent are welcome, the changes suggested to the registration process for generic drugs are controversial and unlikely to be implemented. Although manufacturers of originator drugs conduct clinical trials for their products, they do not conduct bioequivalence tests. Generic companies conduct bioequivalence tests to demonstrate the copy of the drug (generic) behaves exactly the same way in the body as the originator drug. Thus, although generic companies conduct bioequivalence tests, they do not conduct clinical trials. As such, the proposal to remove the requirement for bioequivalence would lead to generic products entering the market without proper tests, which could be harmful to health, and would pose further problems to drug quality control.
In terms of orphan drugs, the exact procedure for registration has yet to be specified. If the "simplified procedure" involved presenting less clinical data, however, then it would be a negative development in terms of potential harmful side effects. Given that companies producing orphan drugs tend to try market their products in the EU and US, they would have to conduct extensive clinical trials. Still, if a certain company aims its product specifically for the Russian market, then less clinical data are required, and if side-effects occur, this could lead to substantial damage to the company. On the other hand, if the "simplified procedure" implies fewer administrative documents, then it would be positive for pharma companies.
Separately, the changes also include the proposal to cancel the current requirement to conduct local clinical and bioequivalence trials, which would be a welcome development for foreign drug manufacturers looking to gain entry for their products in the Russian market.