Technical Regulation оf Safe Handling оf Pharmaceutical Products

K.Z. Nemesh, D. Mendeleev University of Chemical Technology of Russia, Moscow, Russia, korneliya_nemesh@mail.ru Assoc. Рrof. Dr. S.G. Komarova, Associate Рrofessor, D. Mendeleev University of Chemical Technology of Russia, Moscow, Russia, komsvetka@muctr.ru

key words

medicines, life cycle, quality, control, pharmacopoeial article

Medicines have specificity that distinguishes them from other consumer goods and causes the need for special legal regulation of their treatment.
Medicinal products differ from other consumer goods, and this specificity requires special legal regulation of their treatment. We examined the system of medicine regulation as a product throughout the life cycle — from development to retail. We also analyzed the activities of the regulatory and permissive system for quality assurance of medicines, including state registration, permission to use medicine, as well as examination, preclinical and clinical trials, standardization, state control and certification of medicines, medical equipment and medical products. We talked about state quality standards for medicines, which are developed and approved in the following types: general pharmacopoeial article, pharmacopoeial article and pharmacopoeial article of the manufacturer of the medicine.