Issues of national biosafety can only be resolved in close cooperation between the state and business

Data from the Association of Veterinary Pharmaceutical Manufacturers indicates that it has become almost impossible for suppliers from unfriendly countries to undergo the GMP certification procedure. This information is denied by the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor). At the same time, from September 1, the presence of a GMP certificate is mandatory for foreign companies, and some market players are afraid that we may be facing a shortage of veterinary drugs.

 

Let us recall that in recent years the market of drugs for medical use has also often faced the threat of shortages of certain drugs. How to act in such situations? How strategically important is the interaction between the state and business in crisis conditions? Answers to these and other questions were given by the General Director of the Association of Russian Pharmaceutical Manufacturers (ARPM), Victor Dmitriev, speaking at the scientific and practical conference “Issues of National Biosafety”.

 

The speaker turned to the experience gained during the Covid-19 pandemic, when close interaction between government agencies and the business community made it possible to quickly adopt a number of legislative acts that introduced adjustments to the drug registration processes, dictated by time and the current situation. In particular, they discussed the possibility of providing documents in electronic format, expedited obtaining permission to conduct clinical trials, accelerated registration for the most “demanded” drugs and the use of “off-label” drugs, and the possibility of remote trade for over-the-counter drugs and import of medicines unregistered on the territory of the Russian Federation.

Concluding his speech, the head of the ARPM called on everyone to do their work professionally and with love, and then it will turn into art.

Пресс-служба АРФП