It will be possible to register drugs that have the same international nonproprietary names, but different trade names, and being manufactured at the same site. The corresponding government bill No. 327290-7 on amendments to the Federal Law “On Circulation of Medicines” was adopted by the State Duma in the third reading.
After signing a contract with foreign manufacturers, Russian pharmaceutical companies will be able to manufacture the analogs of foreign medicines in addition to their own products.
Moreover, the document will enable foreign manufacturers of medicines to submit a copy of the decision made by the authorized federal executive body on the inspection for the purposes of state registration of the medicinal product. In essence, the registration and expert examination of drugs manufactured abroad and in Russia will be carried out in parallel.
The government expects that this initiative will allow to simplify the procedure of state registration of medicinal products without causing any deterioration of their quality.
“This law will allow foreign medicines to gain access to the market of the Russian Federation within a shorter period, and it will also contribute to the development of contract manufacturing of medicinal products in Russia,” said Nina Chernyaeva, a member of the State Duma Committee on Health Protection.