In October 2007, the Philippine Senate approved the Quality Affordable Medicine Act. More commonly known as the “Cheap Medicines Bill,” this Act contains many initiatives aimed at lowering drug prices in the Philippines and giving more support to the country’s generic drug... 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
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
In February 2007, the Philippine Senate passed the bill SB2263. This bill shortens the period of patent protection, legalizes parallel importation, allows local generic companies to experiment with drug formulations before patents expire and allows various other actions to help lower drug... Read More
The Philippines’ Department of Health (DOH) has recently issued Administrative Order No. 2007-003 which transfers some medical device regulation responsibilities from the Bureau of Food and Drugs (BFAD) to the Bureau of Health Devices and Technology (BHDT). Joint Bureau Memorandum No. 2007-1... 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
The Philippine Bureau of Food and Drugs has ordered all drug manufacturers, repackers and traders to submit a list of all the products they currently handle, including those still in the registration process. The Bureau is currently revising its documentation procedures and... 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
A law that would allow the government to determine the prices of pharmaceuticals is close to being approved by the Philippine Congress, backed by consumer groups, health workers, clergy, and others. The Drug Prices Regulation Act of 2005 would create a board... Read More