• The Global Harmonization Task Force (GHTF) has invited the Asian Harmonization Working Party (AHWP) to appoint two of its members to participate in the GHTF Study Group 3 Quality Management Systems. Formed in 1998, AHWP is an organization of Asian medical device regulators and industry representatives with the objectives (a) to forge a common direction for the harmonization of medical device regulation in Asia; (b) to encourage increased understanding on the benefits of harmonization; and (c) to facilitate a linkage with GHTF. Currently, the AHWP members are: Brunei Darussalam; People's Republic of China; Hong Kong, China; Indonesia; Korea; Malaysia; Philippines; Singapore; Chinese Taipei; Thailand; Vietnam; Kingdom of Saudi Arabia; South Africa; Cambodia; Laos and Myanmar.
  • OECD issued an inhalation Toxicity Guideline: http://www.oecd.org/dataoecd/54/24/41761788.pdf
  • The commenting period for the EMEA draft “Guideline On The Investigation Of Bioequivalence” http://www.emea.europa.eu/pdfs/human/qwp/140198enrev1.pdf was closed on 31 January.
  • On 30 January 2009, the FDA and Health Canada’s Health Products and Food Branch hosted a meeting to discuss what is being done to help minimize the levels of bisphenol A (BPA) in food. http://www.fda.gov/bbs/topics/NEWS/2009/NEW01955.html.
  • In late 2008, the Finnish Ministry of Social Affairs and Health and the National Agency for Medicines drafted a proposed legislation that aims to clarify the liability of authorities, businesses and professional users of medical devices in order to improve patient and occupational safety of medical devices. http://www.nam.fi/whats_new/3/new_medical_devices_legislation_proposed_to_improve_patient_safety
  • The European Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, CMD(h) posted on their website a letter intended for all marketing authorisation holders for currently authorised medicinal products presented as pressurised metered dose inhalers. The letter requests a review of dossiers to ensure that studies have been performed to establish whether a storage orientation effect exists and if so to ensure that an appropriate recommendation for storage orientation and or re-priming Is included in the product information . http://www.hma.eu/uploads/media/MAHs_storage_orientation_issue.pdf
  • As part of its ongoing effort to screen chemicals for health and environmental effects, Canada publishes Chemical Substance Public Summaries (a series of short fact sheets about chemical substances that are being (or have been) assessed in Canada for their possible risks to human health and the environment). See http://www.chemicalsubstanceschimiques.gc.ca/en/index.html for more information on the “Challenge.”