New Quality System: Pharmacopoeia plus
Self-Regulation
Prof. Dr. V.V. Pomazanov, Professor, State Humanitarian University of Technology, Moscow, Russia, allya2005@yandex.ru
Dr. V.A. Kiseleva, Dean, Faculty of Pharmacy, State Humanitarian University of Technology, Moscow Region,
Orekhovo-Zuevo, Russia
N.I. Lidyaeva, Deputy Head, Research Laboratory of Automation Management, MAI (National Research University), Moscow, Russia
Dr. E.I. Shol’, Deputy Head of Department, Economic Theory, MAI, Deputy Head of Working Group, Self-Regulation
in Industry, Council of Self-Regulation, RF CCI, Moscow, Russia
key words
pharmaceuticals, pharmacopoeia, self-regulation, guarantees, fair business
References
The state registration body — registration body — the Institute of Pharmacopoeia — is an important part of the mechanism of state regulation in the Russian pharmaceutical market. However, as the state supervision authority while issuing the registration certificate for the product, it guarantees the consumer a minimum level of medicines safety. Experience has shown that market introduction of the serial product does not always correspond to the reference sample, registered in the Pharmacopoeia. We consider it expedient to use the possibilities of self-regulating organizations to solve this problem. In our opinion, the Pharmacopoeia is the pharmaceutical form of certification, solving the problem of food safety prevention, while self-regulation institute provides a financial guarantee of the declared product quality. When combining Pharmacopoeia and self-regulatory institutions it will be possible to form the country’s system ensuring market advantages of fair business.
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