On August 15, 2009, the Philippines Department of Health announced that all drug dispensing outlets in the country are to provide a total of 21 medicines and all their various preparations at half-price. This news comes after President Gloria Macapagal-Arroyo signed Executive... Read More
The Association of Southeast Asian Nations (ASEAN) countries gathered for five days from May 25-29, 2009 for the 16th Meeting of the ASEAN Consultative Committee for Standards and Quality-Pharmaceutical Product Working Group (ACCSQ PPWG). The event was held in the Philippines, and... Read More
On April 10, 2009, the Association of Southeast Asian Nations (ASEAN) Economic Ministers signed the ASEAN Sectoral Mutual Recognition Arrangement (MRA) for Good Manufacturing Practice (GMP). When implemented, GMP certification and inspection reports received in one ASEAN member nation (in accordance with... Read More
Navigating global regulatory markets can be a challenge, particularly when multiple countries in a region differ in their rules. Playing by a common set of rules for medtech regulation is about to get a little easier in Southeast Asia, as a group... Read More
Managing Asian cultural and business diversity can be very complex for Western companies. Each country has its own culture, history, ideology, language and philosophy: a strategy in Taiwan may not work in China, and vice versa. Understanding the local mentality, beliefs, and... Read More
The Association of South East Asian Nations (ASEAN) is preparing for the upcoming implantation of the ASEAN Common Technical Dossier (ACTD) in January 2009. Drafted by the Pharmaceutical Product Working Group (PPWG) of the ACCSQ (ASEAN Consultative Committee on Standards & Quality),... Read More
President Gloria Macapagal-Arroyo of the Philippines signed Republic Act no. 9502 on June 6, 2008. This Act is officially titled the “Universally Accessible Cheaper and Quality Medicines Act of 2008,” and was originally proposed in October 2007. The new law amends the... Read More
ASEAN industry members assembled in the Philippines in January 2008 to announce committee members of the new ASEAN Medical Device Industry Association (AMDIA). AMDIA is focused on representing the common regulatory interest of the medical device industry in ASEAN. It will also... Read More
The Asian Harmonization Working Party (AHWP) has finalized two documents on the Safety Alert Dissemination System (SADS) on January 23, 2008. The main goals of SADS are the following: To define a structure for disseminating medical device safety alerts among AHWP members;... Read More
When medical companies think of bringing their products to the Asian markets, they typically think of larger countries like China, Japan, or Korea first. However, other smaller Asian countries such as Singapore and Malaysia can be worthwhile destinations as well. Although they... Read More