Emerging Markets Regulatory Tracker: Brazil, China, India (Vol. 1 No. 15)
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, June 27, 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 (Vol. 1 No. 14)" - Scrip, 27 Jun, 2011.). The Emerging Markets Regulatory Tracker is prepared for PharmAsia News by RegLink Associates LLC. Brazil To Regulate Compassionate Use Brazil's regulator Anvisa is calling for public comment on its proposal to regulate so-called compassionate use of drugs to allow patients with severe and debilitating diseases with no treatment option available to have access to drugs still undergoing development in Brazil. Nanotechnology And Biotech Focus of Pan American Drug Regulatory Network Representatives from government, the private sector, academia, and consumer groups will tackle issues of regulatory interest, such as nanotechnology, information systems and communication, transparency and biotechnology products at the sixth Pan American Drug Regulatory Network (PARF) conference hosted by Anvisa July 6-8. The Pan American Health Organization (PAHO) is sponsoring the meeting. Ready For China's New ADR Rules? China's State FDA issued a countrywide notice alerting all local drug agencies and health administration departments of the obligations of drug companies to take the initiative to carry out key monitoring and proactive risk management measures to control drug risk. The notice also underscored the need for all local authorities to implement and adhere to the revised Rules for 'Adverse Drug Reaction Reporting and Monitoring' in effect as of July 1, 2011. India's New IV Guidance India's regulatory agency, the Central Drugs Standard Control Organization, issued June 28 new Guidelines for IV fluids that address proper distribution, storage and administration practices. 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. |