Emerging Markets Regulatory Tracker: Australia, Brazil, China (Vol. 3 No. 50)
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 Emerging Markets Regulatory Tracker is prepared for PharmAsia News by RegLink Associates, which tracks regulatory, policy and health technology assessments around the world for biopharma and medical device executives.
Read all Breaking News from RegLink.
The previous issue of the Emerging Markets Regulatory Tracker appeared here: (Also see "Emerging Markets Regulatory Tracker: Australia, Brazil (Vol. 3 No. 49)" - HBW Insight, 1 Aug, 2013.)
TGA Releases International Strategy
Australia’s Therapeutic Goods Administration has released an outline of the agency’s goals in the international arena for the next three years. The International Engagement Strategy 2013-2015 links current Australian priorities for international engagement that are necessary to support effective therapeutic goods regulation with the TGA's day-to-day activities and sets clear goals for international engagement activities, including:
• Driving regulatory harmonization to reduce duplication and improve efficiency and effectiveness in pre and post market evaluation of therapeutic goods.• Development of the joint Australia and New Zealand Therapeutic Products Agency (ANZTPA).• Ensuring the integrity of supply chains and overseas manufacturers' compliance with Manufacturing Standards.• Contributing to the delivery of Australia's global and regional public health responsibilities.• Improving mechanisms for exchanging information.• Building greater regulatory capacity in the Asia Pacific region.• Maximizing the value of international activities.
Brazil’s Anvisa Defends Generics
Brazil’s National Agency for Sanitary Surveillance (Anvisa) defended generics in an attempt to counter the negative comments about the effectiveness and quality of generic medicines made on a radio program by a commentator, Edmilson Migowski on July 29. Anvisa countered that new drug marketing approval applications receive priority by the agency, noting that it is not true to say that there is no incentive to produce new drugs in Brazil. Moreover, Anvisa stated that it guarantees the quality of generic manufacturing facilities and generic products, even if a supplier is changed because the new supplier is also inspected by ANVISA.
China Imported Device Recall Notification Issued
China’s FDA issued a notice on Aug. 2 to the provinces and municipalities concerning the recall of imported medical devices due to defects caused by either product design or manufacturing. The notice identified devices by GE Healthcare, Respironics California, Inc., Medtronic PLC and Gambro Kathetertechnik Hechingen (Gambro AB). Local food and drug authorities were asked to strengthen supervision and management of the devices involved in the recall and directed to provide further information in the "Medical Device Recall" column – see below:
Respironics California, Inc. Companies ventilator for recall
GE Healthcare company image archiving and transmission system for recall
Medtronic Inc. Companies implantable neurostimulation electrode recall
Gambro Kathetertechnik Hechingen company indwelling catheter for recall