Roszdravnadzor sent letters  to medical organizations about the organization of pharmacovigilance work, including criteria for auditing the pharmacovigilance system. These are the first mass audits after regulatory changes in pharmacovigilance.

In its letter, Roszdravnadzor identifies three main signals that are important not only for the recipients of the message, but also for the industry as a whole: the regulator reminds about compliance with laws, focuses on the electronic form of filing messages on adverse reactions to the database of AIS Pharmaconadzor 2.0 (this type of filing is preferable), and informs about the need for internal audit of the pharmacovigilance system. A letter from the regulator may lead to an increase in declarability and, as a result, an increase in the workload for pharmacovigilance systems, including for registration certificate holders.

Companies that have prepared in advance, optimized their pharmacovigilance systems and brought them in line with legislation are ready to increase the load and can quickly process the information flow. The preparation means a system of operational procedures, a well-structured process for receiving and storing data, compliance with deadlines for reporting of adverse reactions, both for single messages and for regular reporting. What matters is the availability of an electronic system for data storage, compliance of the system with regulations, including validation, the level of qualification of employees for use of the system. A properly organized pharmacovigilance system will enable registration certificate holders to respond quickly and qualitatively to messages received.

The increase in declarability is of positive importance to improve the quality of pharmaceuticals registered in Russia and the medical care provided to the population. Pharmaceutical companies get quick and objective information about their products and can take timely corrective actions if necessary.