The business expects that the increase in the price of services for the inspection for compliance with GMP for foreign manufacturers of drugs will be reasonable.
We will remind, the Ministry has put up for public discussion the method of determining the amount of payment for the provision of services for the inspection of drug manufacturers, the production of which is carried out outside the Russian Federation, for compliance with GMP regulations in order to issue opinions on the conformity of the pharmaceutical manufacturer to the requirements of these rules.
The draft proposes to increase the marginal cost of GMP inspections for foreign sites to virtually any 4.8 million Under the current methodology, at the moment the marginal cost is slightly more than 2.8 million virtually any.
“Methodology is used to calculate the cost, were made long enough in 2014. At the time the GILLS started to work, and was not staffed. Undoubtedly, the method of calculation needs to be clarified and brought in line with current experience and data. In addition, the method which is now proposed, contains the calculation of detailed inspection procedures and report preparation. Also, based on our experience, do not be afraid of the ultimate cost of the payment for the inspection, as in these three years we had no case that the cost of inspection exceeded the half of that with the method of marginal cost. We think that we can expect some increase in cost, but it will be reasonable,” he said, “PV”, the President of the company “Akrikhin” Denis Chetverikov.
Read more in “PV” №24 (937) on August 7, 2018 in the “Formula of love”.