Thailand’s Food and Drug Administration (FDA) is planning to increase fines on importers, sellers, and manufacturers of fake drugs. Currently, the FDA is proposing to amend Drug Act of B.E. 2510 where manufacturers can be fined up to 5 million baht (about... Read More
The Asian Harmonization Working Party (AHWP) had its last meeting on October 26 and 27 in Chengdu, China, where it discussed schedules and plans for the Common Submission Dossier Template (CSDT), Post-market Alert Systems (PMAS) and other tasks. For CSDT and PMAS,... Read More
The Medical Device Product Working Group of the ASEAN Consultative Committee for Standards and Quality (ACCSQ-MDPWG) held a meeting from July 30 to August 2, 2007. In this meeting, the ASEAN (Association of Southeast Asian Nations) countries discussed proposals for conformity assessment... Read More
Based on Ministerial Announcement No. 34 B.E. 2549 (2006), certain medical device importers in Thailand must submit, in addition to the required Certificate of Free Sale, proof of manufacturing quality of an imported product. Importers can submit either a GMP certificate or... Read More
The Medical Device Product Working Group of the ASEAN Consultative Committee for Standards and Quality held a meeting from July 30 to August 2, 2007 to discus various topics and strategies to increase harmonization of medical device regulations across the ASEAN countries.... Read More
Recent reports on counterfeit drugs in Thailand have prompted several government agencies, including the Intellectual Property Department, to investigate and crack down on fake drugs. The Food and Drug Administration (FDA) in Thailand said that over 30 sellers of fake drugs were... Read More
The Asian Harmonization Working Party (AHWP) has recently drafted a post-marketing system to harmonize medical device adverse event reporting. AHWP members have varied systems for adverse event reporting, and some have no system at all. The new draft document aims at reducing... Read More
Recently, Thailand has been focusing on upgrading its standards and promoting increased investment in its pharmaceutical industry. By 2008, the government has mandated that all manufacturing companies must update their quality systems to meet Good Manufacturing Practice standards based on the international... Read More
The World Health Organization (WHO) and various international partners came together in Germany November 2006 to develop a task force focused on preventing the global spread of counterfeit medicines. The International Medical Products Anti-Counterfeiting Taskforce, or IMPACT would cover legal, technological, communications... Read More
The Asian Harmonization Working Party (AHWP) has recently drafted a “Common Submission Dossier Template” (CSDT). If adopted, this would allow medical device companies to use one common form when submitting to any of the 13 countries in the AHWP. By adopting this... Read More