Emerging Markets Regulatory Tracker: Brazil and China (Vol. 2 No. 20)

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.

For a free 30-day trial to RegLink's Global updates, click here.

The previous issue of the Emerging Markets Regulatory Tracker appeared here: (Also see "Emerging Markets Regulatory Tracker: Brazil (Vol. 2 No. 19)" - Scrip, 14 May, 2012.)

Brazil Implements Freedom Of Information Law

Greater transparency is an integral part of the reorganization of Brazil’s national regulatory agency, ANVISA, and the agency will now release, upon written request, copies of all documents in its possession, other than those classified as confidential. The Access to Information Law (Law No. 12.527/2011) establishes as a fundamental principle the constitutional right of public access to public information. The law is now in effect according to the ordinance published May 18 that notes requests for information must be responded to within five working days by the ANVISA organizational unit responsible for the document. The only charge for the service will be the cost of reproduction of the requested documents. Information about the procedure has been posted online here.

Brazil's Criteria For Confidentiality

A notice (Ordinance No. 748-B/2012) published by ANVISA May 18 sets forth the criteria the agency will use for classifying materials as confidential and thus ineligible for release under the Access to Information Act. Examples of what would be classified as non-releasable include information relating to scientific studies and research projects in progress, intelligence activities, ongoing monitoring, and information treated as confidential in connection with other international bodies. The agency also established a Permanent Committee for the Evaluation of secret documents (748-A/2012 Ordinance) that will, among other things, advise the agency on the classification of sensitive information and prepare an annual list of classified and declassified documents, which will be available on the Internet.

Brazil Attends WHO Seminar

The question posed for regulators from 30 countries at the International Seminar on Health Regulation was, “Is it possible to identify a form of cooperation common to drug regulatory agencies of countries?” The seminar, held in Geneva May 18, included representatives from Australia, Argentina, Brazil, France, India, Portugal, South Africa, United States, and the UK. The seminar was a joint initiative of the National Health Surveillance Agency (ANVISA) and the World Health Organization.

China Signs MOU With Ukraine

State FDA Commissioner Yin Li signed a bilateral Memorandum of Understanding with Ukrainian State Drug Administration Deputy Director Andrei Zakharash May 17. The MOU will strengthen bilateral cooperation in regulatory matters, especially those relating to pharmaceuticals. Representatives from SFDA’s International Cooperation Department and the head of SFDA’s Drug Registration Department attended the meeting.

SFDA Certifies Four Device Testing Centers

China’s SFDA has certified the following medical device testing centers to conduct conformity assessments for a period of five years: Anhui Medical Device Testing Center for single use sterile syringes, and 145 other medical device products; China Food and Drug Verification Research Institute for carbon dioxide laser treatment machines and other medical device products; Jiangsu Province Medical Device for electrical equipment, and 152 other medical device products; and Shanghai Food and Drug Packaging for environmental conformity testing on manufacturing clean rooms.