Roszdravnadzor strengthens its drug efficacy and safety monitoring (pharmacovigilance) aimed at identifying, assessing and preventing the adverse effects of drug use. From April 1, the pharmacovigilance activities will also be carried out following the reports obtained from individual citizens, individual entrepreneurs and legal entities. In addition, pharmacovigilance will be based on information received:
- From periodic safety update reports submitted to Roszdravnadzor;
- From development safety update reports submitted to Roszdravnadzor;
- In the course of government control (surveillance) in the area of circulation of medicinal products.
Kliment Nechaev, the lawyer of corporate practice at Capital Legal Services, expects that this novelty will increase the administrative burden on pharmaceutical companies. It is possible that the latter will respond by raising the drug prices, especially considering that a state duty on drug registration will be introduced on April 7. However, the introduction of state duty is a good news for establishing a common market for medicinal products within the Eurasian Economic Union. According to Dmitry Churin, the managing lawyer of corporate practice at Capital Legal Services, such state duty is the next and necessary step towards the effective and full-fledged functioning of the common market.