Russian manufacturers of veterinary vaccines will see simplified market entry for their products. The new measure is outlined in a draft resolution developed by the Russian Ministry of Agriculture, which is undergoing public discussion on the portal for draft legal acts until February 4.
The document allows the first two batches of a new Russian-made immunobiological veterinary drug (vaccine, serum) to be released onto the market without undergoing state testing and without obtaining a permit for entry into civil circulation.
To take advantage of this opportunity, the manufacturer must notify Rosselkhoznadzor (the Federal Service for Veterinary and Phytosanitary Surveillance) of the release of these batches. This must be done within 5 calendar days after an authorized specialist of the enterprise confirms the drug’s compliance with state registration requirements. In the case of an import-substituting vaccine, research protocols for samples must additionally be attached.
The third and subsequent batches of the drug will undergo the standard quality control procedure.
The explanatory note to the document states that the innovation will accelerate the entry of new products into civil circulation and reduce the financial burden on veterinary drug manufacturers by cutting the number of procedures.
“The cancellation of testing for Russian-made immunobiological veterinary drugs prior to market entry implies a shift of responsibility for product quality directly to the manufacturer. In this regard, the role of the internal Good Manufacturing Practice (GMP) quality system increases,” Semyon Zhavoronkov, Executive Director of the Association of Veterinary Pharmaceutical Manufacturers, told GxP News.
Zhavoronkov believes the initiative can be seen as an internal regulatory experiment, the consequences of which, nevertheless, also affect the Eurasian Economic Union (EAEU). “The Union’s rules for the circulation of veterinary drugs do not provide for control testing when bringing products to the Russian market, but Russian legislation requires it. Thus, if a manufacturer from another EAEU country, for example, Belarus, registers a product under the Eurasian procedure, to supply it to Russia, they will need to pre-test it. A similar rule currently applies to Russian companies. The proposed approach aims to change this—I remind you, only for the first two batches of a new drug. Thereby, Russian manufacturers will receive a preference. Furthermore, the new procedure will reduce the burden on the state Center for Quality and Standardization of Medicines for Animals and Feed—the only one in the country conducting such tests,” he said.
