Russian Ministry of Industry and Trade and State Institute of Drugs and Good Practices took part in International Conference of Drug Regulatory Authorities
On September 3 – 7, representatives of the Russian Ministry of Industry and Trade and the State Institute of Drugs and Good Practices participated in the International Conference of Drug Regulatory Authorities (ICDRA) in Dublin, Ireland. ICDRA convenes every two years under the auspices of the World Health Organization (WHO).
This time the conference was devoted to Smart Safety Surveillance. On the sidelines, the delegates discussed issues of drugs quality, problems of adulterated pharmaceuticals, reforms aimed at strengthening the regulatory system, access to the regulation of clinical trials, as well as harmonization of approaches and enforcement practices in the field of supervision and control of the pharmaceutical market, new technologies, and development of partnership between international regulators.
The ICDRA platform gathered about 500 representatives of regulating agencies and health professionals from 94 countries. The Russian Ministry of Industry and Trade was represented by its Licensing and Inspection Unit of the Department of Pharmaceutical and Medical Industry Development. The State Institute of Drugs and Good Practices sent Head of the Department for Cooperation between EAEU Pharmaceutical Inspectorates, and Head of International Cooperation.
The contacts established at the conference will foster professional interaction between the Russian GMP Inspectorate and WHO, the European Medical Agency (EMA), the Pan American Health Organization (PAHO), the International Coalition of Medicines Regulatory Authorities (ICMRA), and regulators from the European Union, Africa, Asia, and America. In the outcome of the conference, there will follow practical actions and cooperation aimed at strengthening the position of the Russian GMP Inspectorate in the international professional community.
- 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
- Pharma is under control
- PIC/S Meetings in Toyama (Japan)
- Russia will be able to join PIC/S and break into new pharmaceutical markets