Emerging Markets Regulatory Tracker: Brazil, China, Russia (Vol. 1 No. 25)
This article was originally published in PharmAsia News
Executive Summary
The Emerging Markets Regulatory Tracker is a periodic PharmAsia News feature that summarizes and links to important regulatory developments impacting the biopharma and medical device industries in the Asia Pacific region and other emerging markets. The most recent issued appeared in PharmAsia News, Sept. 5, 2011. The Emerging Markets Regulatory Tracker is prepared for PharmAsia News by RegLink Associates LLC.
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The Emerging Markets Regulatory Tracker is a periodic PharmAsia News feature that summarizes and links to important regulatory developments impacting the biopharma and medical device industries in the Asia Pacific region and other emerging markets. The most recent issued appeared in (Also see "Emerging Markets Regulatory Tracker: Australia, Brazil, China, Russia (Vol. 1 No. 24)" - Scrip, 5 Sep, 2011.). The Emerging Markets Regulatory Tracker is prepared for PharmAsia News by RegLink Associates LLC. Brazil Launches Health Research Platform On September 8, Brazil's Minister of Health announced the government's investment in a platform to strengthen research and innovation in health, and provide greater flexibility and transparency in the approval of drug trials. An integral part of this platform is the national Registry of Clinical Trials (Rebec), the first system of its kind in English that places Brazil among the select group of countries with similar systems. Thus, national researchers no longer need to rely on foreign platforms to register their trials. Brazil Looks To EU Experience To Regulate Cellular Therapies With Europe's Committee on Advanced Therapies as a model, Brazil plans to establish an interinstitutional body - the Technical Advisory Committee on Cellular Therapies - to regulate therapies that result from the cultivation, selection and manipulation of cells. The national drug agency, Anvisa, is convening an October 17-18 technical seminar to discuss the regulatory framework and the ethical standards that should be followed by developers of therapeutic treatments derived from human cells. China's SFDA Meets with Iran On September 6, SFDA's Deputy Director Wu Zhen met with visiting Iranian co-director of the Office of Technology and Innovation, and Technological Cooperation and Iranian presidential adviser Amir Hamid Resa. The two sides discussed ways to enhance bilaterla exchanges, promote Chinese medicine and bio-pharmaceutical and exchanged views on other fields of cooperation. China Focuses On Drugs That Terminate Pregnancy China's State FDA issued a notice to provinces and municipalities on the implementation of the national program on fetus gender identification and sex-selective termination of pregnancy for non-medical purposes, with a focus on the drugs that terminate pregnancy. The program has the support of the All-China Women's Federation, the National Population and Family Planning Commission, and the Ministry of Health. Illegal Chinese Devices On Russian Market Russia's Federal Service on Surveillance in Healthcare and Social Development reported finding unregistered medical devices on the market from China, Thailand and Belarus. The products include eye massagers and surgical gloves and are being withdrawn from the market. RegLink Associates publishes global updates on drug, biologic and medical device regulatory, policy and health technology assessment to save companies time that would otherwise be spent finding, monitoring and translating developments on websites worldwide. |