IN NOVEMBER 2020, CHANGES ARE THOUGHT TO TAKE EFFECT TO RESOLUTION NO. 1361 OF THE GOVERNMENT OF THE RUSSIAN FEDERATION DATED 5 SEPTEMBER 2020, WHICH DEFINES THE RULES OF INSPECTING PHARMACEUTICAL MANUFACTURERS FOR COMPLIANCE WITH GMP REQUIREMENTS AND INTRODUCES A MECHANISM FOR SUBMISSION OF A CAPA PLAN BY FOREIGN MANUFACTURERS.
In order to best implement the Resolution provisions, the RF Minpromtorg is now developing a draft of the official document regulating the method of fee calculation for the inspection of foreign-produced drugs manufacturers as well as the fee limit for such services.
Besides, Minpromtorg is reviewing the inspection report template used to report the results of GMP compliance inspection. Specifically, it might amend the sections to be filled after the analysis of the CAPA plan.
The program of the V All-Russian GMP Conference touches upon a number of matters of regulation and timely changes to legislative initiatives related to the pharmaceutical industry.