SID & GP representative addressed the ISPE Indonesia Annual Conference
On June 24, 2019 in Jakarta (Indonesia) within «regulatory table» at the ISPE Indonesia Annual Conference Division’s Supervisor for International Cooperation of the Pharmaceutical Inspectorates of FSI «SID & GP» Vladimir Orlov gave a presentation on the overview of regulation of medicine circulation in Russia.
The representative also spoke regarding the organization and conducting of the GMP inspections in the Russian Federation and the Eurasian Economic Union and touched upon the following subjects:
— Key statistical indicators on the conducted GMP inspections on behalf of the Russian state GMP-inspectorate, authorized to inspect foreign pharmaceutical producers for compliance with the GMP standards («SID & GP»);
— Inspection procedures for compliance with the requirements of Good Manufacturing Practice within
the Eurasian Economic Union, including:
- organizational arrangement of pharmaceutical inspections for compliance with the Eurasian Economic Commission’s Council Decision № 83 as of 03.11.2016 «On approval of the Rules
for conducting pharmaceutical inspections»;
- initiation of the GMP inspections for compliance with the Eurasian Economic Commission’s Council Decision № 78 as of 03.11.2016 «Regarding Rules for registration and expertise of drugs for medicinal use»;
- possibility of the joint GMP inspections within the Eurasian Economic Union in accordance with the Eurasian Economic Commission’s Council Decision № 91 as of 03.11.2016 «On approving the Rules of ensuring the holding of the joint pharmaceutical inspections».
— Current procedure for the mutual recognition of the GMP inspection results within the Eurasian Economic Union in relation to the manufacturing sites, situated on the territory and outside of the Eurasian Economic Union;
— Overview of the statistical data on the current results of the registration of drugs in the single market of the Eurasian Economic Union and on the conducted GMP inspections as per the rules of the Eurasian Economic Union;
— Results of the cooperation of Russia’s regulatory authorities with the PIC/S concerning the accession to the organization.
- What is in the Programme of V GMP-conference?
- The rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements have been changed
- FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation and company Sandoz held the first online forum on biotechnologies
- The SID&GP under the auspices of the Ministry of Industry and Trade of the Russian Federation conducted the first online inspection of Roche’s manufacturing site
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed