Russia may simplify registration of new antibiotics

| By | Antibiotics, Drug Registration

This was announced by Sergey Glagolev, the Head of the Division for Monitoring the Efficacy and Safety of Medical Products, the Department of the State Quality Control of Medical Products of Roszdravnadzor.

“One of the problems in introducing modern antimicrobial drugs to the market is the reluctance of major pharmaceutical companies to conduct classical three-phase studies of medicinal products, because they are unprofitable. We propose to consider the issue of registration on the basis of limited data with the subsequent strict post-registration monitoring similar to the registration scheme for breakthrough or orphan medicines,” said the official.

According to Mr. Glagolev, the therapy standards do not allow to completely avoid irrational prescribing of antibiotics and, therefore, the supervisory authority supports the introduction of clinical guidelines into medical practice.

Roszdravnadzor has taken the initiative to amend the Federal Law No. 323-FZ “On the Fundamentals of Public Health Protection in the Russian Federation” with a provision that allows the regulator to make control purchases of antibiotics in pharmacies in order to identify cases when they are sold without prescription.

Mr. Glagolev is concerned that “the practice of over-the-counter sales of antibiotics is very widespread.” In addition, he called on the health authorities to inform Roszdravnadzor about the cases of antibiotic resistance.