Main functions and objectives:
Evaluation of biological medicinal products (BMPs), including review of clinical trial applications, evaluation of the quality control methods proposed by the applicant, and evaluation of the benefit/risk ratio.
Preparation and submission of expert reports and conclusions on BMP evaluation.
Scientific and information support of BMP evaluation.
Maintenance and improvement of the Quality Management System.
Participation in BMP-related research.
Participation in academic, practice-oriented, and administrative meetings, seminars, conferences, symposia, plenary sessions, and congresses on BMP-related issues.
Participation in the elaboration of requirements for BMP safety, efficacy, manufacturing conditions, and quality control.
Elaboration of recommendations for BMP use in the Russian Federation.
Holding educational and professional development trainings for experts specialising in BMP evaluation.
BMPEC structure
Division for Antibacterial Medicines Evaluation
Division for Antiviral Medicines Evaluation
Division for Allergens, Cytokines, and Other Immunomodulators Evaluation