WHO and Russian Federation to cooperate toward standards for evaluation and registration of biotherapeutic and biosimilar medicines in Russia
Moscow, May 16,2013. Today several countries have regulatory requirements in place for the development and evaluation of biotherapeutic and biosimilar medicines. The European Union, for example, provides unified standards and guidelines that are effective in the entire region. In Russia, on the contrary, these topics are not yet regulated. This is one of the key points that international and Russian experts are discussing in the context of the two-day workshop Biotherapeutic Medicines – Regulatory Challenges and Current Practices. Approaches for Harmonization.
R-Pharm Group Becomes a New AIPM Member: Integration in the Best Interest of Russians
April 1, 2013, Moscow – The Association of International Pharmaceutical Manufacturers announces extension of the Association member list. On March 27, 2013 the General Meeting of AIPM members decided on the membership of R-Pharm Group. It is an important achievement for the Russian pharmaceutical market confirming the inconvertibility of partnership between Russian and international pharmaceutical companies and their further integration.
The quality of treating Russian patients is at stake
Draft documents limiting the state purchases of foreign medication do not take into account the Russian Federation citizens’ rights for affordable and high-quality treatment. It has been announced by the participants of the press conference devoted to the discussion on the draft RF Government Decree “On introducing additional requirements to order placement participants in case of placing orders for the provision of medications" and draft Law prepared by the Ministry of Industry and Trade of Russia and devoted to the criteria in accordance to which medications can be attributed to medicinal products of the Russian origin.
Introducing company interests, on which share it is necessary about 80 % made and sold in the world of pharmaceutical production and the medical equipment, AIPM considers as the priority cooperation with the Russian bodies of public health services, and also with legislative and executive branches of the power, for the purpose of working out of the program of creation of favorable conditions for sale and-or production of the international pharmaceutical companies in territory of the Russian Federation