21 October 2019
The working meeting between pharmaceutical inspectorates’ representatives of Russia and Republic of Belarus took place in Minsk city last week, initiated by the Ministry of Health of the Republic of Belarus, in terms of which representatives of authorized entities of the two EAEU member countries exchanged opinions about organizational structures and current quality systems of medicines.
On October 8, in the Republic of Belarus, at the premises of the unitary enterprise “Center for examinations and tests in Health Service”, there was a discussion of the matters on inspections at pharmaceutical manufacturing sites and their compliance with GMP regulations of the Eurasian Economic Union. The discussion was held at the premises of the unitary enterprise “Center for examinations and tests in Health Service” with the participation of Director, Sergey Marchenko, and FSI “SID&GP” representative from the Russian side.
Inspectorate member-states of the Eurasian Economic Union at the working group on conducting pharmaceutical inspections on compliance with GMP standards in the field of drug circulation discuss on a regular basis legislative acts of the drug regulation in terms of harmonization with the law of the Eurasian Economic Union and issues related to the cooperation of inspectorates.
At the held meeting with the Belorussian colleagues, several issues were discussed, including the quality system of the pharmaceutical inspectorate, rules regarding pharmaceutical inspections, requirements for the inspectorates, the consequences of the non-conformities with the requirements for the GMP EAEU, GDP and GLP inspections within the Eurasian Economic Union.
Having familiarized themselves with the internal structures, legislative framework and quality system of the regulatory authority of Belarus, the sides paved the way for further collaboration and cooperation.
The next meeting of the GMP inspectorates of all the 5 member-states of the Eurasian Economic Union is planned for October, 28 in Moscow within the specialized session for the Union regulators at the Conference “Development of the Pharmaceutical Market in the Eurasian Economic Union”. Such meetings are important instruments for developing a unified approach towards conducting inspections and implementation of continuous work on the harmonization of requirements.Print
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