Emerging Markets Regulatory Tracker: Australia, Brazil, China and Japan (Vol. 1 No. 10)
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 issue appeared in PharmAsia News, May 23, 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 issue appeared in (Also see "Emerging Markets Regulatory Tracker: Australia, China, India and Russia (Vol. 1 No. 9)" - Scrip, 23 May, 2011.). The Emerging Markets Regulatory Tracker is prepared for PharmAsia News by RegLink Associates LLC. New Amendments to Australia's Classification of Medicines in June Amendments to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) are to take effect June 1 incorporating the recent decisions concerning classification of medicines - whether pharmacy, pharmacy only, Rx, controlled substance, etc. - including model provisions about containers and labels, and recommendations about other controls on medicines. Medical Devices: a Cornerstone of Brazilian Industrial Development? The 18th edition of the Compendium of Legislation, Health Medical Devices, which provides companies with guidance regarding the standards for the production and marketing of medical devices, was just released by the Brazilian agency Anvisa together with the Agency for Industrial Development (ABDI) and the Service to Support Micro and Small Enterprises (Sebrae). Health Reform Prompts Revised ADR Reporting and Monitoring Procedures China State FDA's Revised Adverse Drug Reaction Reporting and Monitoring Procedures will officially be implemented July 1. The revised procedures are touted as a major initiative in the ongoing implementation of health reform and the safe use of drugs. SFDA's Closer Cooperation with the UK's MHRA The May 23 bilateral discussions in Beijing between SFDA's Shao Mingli and Kent Woods, the British Secretary for the Medicines and Healthcare Products Regulatory Agency (MHRA), focused on China's new good manufacturing practices regulations and the next steps needed to advance the memorandum of understanding between the two agencies. PMDA's Oral Hypoglycemic Clinical Guidance Administrative Record Now in English Japan's Pharmaceuticals and Medical Devices Agency published English translations of the complete administrative record concerning the clinical evaluation guidance for oral hypoglycemics including notifications, administrative notices as well as a Q&A regarding the guidance for "the convenience of stakeholders." 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. |