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RUSSIAN AND FOREIGN LEGISLATION ON REGULATION OF POST APPROVAL VARIATIONS IN THE DOSSIER FOR THE MEDICINAL PRODUCTS
Yu.V. Olefir, V.A. Merkulov, E.A. Soloviev, E.A. Ustyugova, L.V. Sayapina, V.P. Bondarev
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation, 127051, Moscow, Russia
Abstract: Drug licensing is the most crucial factor for effective market regulation of pharmaceuticals. The rapid development of the pharmaceutical industry, emergence of new scientific data, and changes in composition of medicinal products drive the need for introduction of variations in original registration dossiers. The process of such variation approval implemented in a particular country is the key factor in assessing the effects of the variation on the quality, safety and efficacy of the medicinal product, and sets a timelines for their realization. The present article describes existing classifications of variations, which are adopted in the European Union (EU), USA and Russia. Also the article concerns the upcoming changes in Russia in the scope of Eurasian Economic Union establishment and the necessity of harmonizing the procedure with the European Union.
Key words: drugs; post-approval variations; classification; guidelines; normative documents.
For citation: Olefir YuV, Merkulov VA, Soloviev EA, Ustyugova EA, Sayapina LV, Bondarev VP. Russian and foreign legislation on regulation of post approval variations in the dossier for the medicinal products. Scientific Centre for Expert Evaluation of Medicinal Products Bulletin 2015; (4): 11–15.
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AUTHORS:
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation, 8 Petrovsky Boulevard, Moscow, 127051, Russian Federation.
Olefir YuV. Director General. Doctor of Medical Sciences.
Merkulov VA. Deputy Director General for the expertise of drugs. Doctor of Medical Sciences, professor.
Soloviev EA. Deputy head of Office of expertise of antibacterial medical immunobiological preparations of Center of expertise and control of medical immunobiological preparations.
Ustyugova EA. 1st category expert of Office of expertise of antibacterial medical immunobiological preparations of Center of expertise and control of medical immunobiological preparations. Candidate of Biological Sciences.
Sayapina LV. Chief expert of Office of expertise of antibacterial medical immunobiological preparations of Center of expertise and control of medical immunobiological preparations. Doctor of Medical Sciences.
Bondarev VP. Director of Center for examination and control of medical immunobiological preparations. Doctor of Medical Sciences, professor.
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