Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) recently reached an agreement with the U.S. Pharmacopeia (USP) in February 2010 and consequently has sent out one of its executive employees as a liaison officer to the USP. This liaison officer will be responsible... Read More
The Asian Harmonization Working Party (AHWP) posted their summary report on December 31, 2009 about their latest meeting in Hong Kong. The 14th AHWP meeting took place on November 6-7, 2009. During the meeting, AHWP members discussed their work plan and targets... Read More
Asia is emerging from the global recession faster than other regions in the world. This article goes through some of the major regulatory updates in various Asian countries. Read More
Japan 's Ministry of Health, Labor, and Welfare (MHLW) with the Pharmaceuticals and Medical Devices Agency (PMDA) concluded confidentiality agreements with the European Commission's Directorate General Enterprise and Industry and Health Canada. Both these agreements were signed in October 2009. The United... Read More
Japan ‘s Ministry of Health, Labor, and Welfare (MHLW) with the Pharmaceuticals and Medical Devices Agency (PMDA) concluded confidentiality agreements with the European Commission’s Directorate General Enterprise and Industry and Health Canada. Both these agreements were signed in October 2009. The MHLW... Read More
The Certificate of Pharmaceutical Products (COPP) and Good Manufacturing Practice (GMP) under World Health Organization (WHO) certification will be taken over by the Drug Controller General of India (DCGI). Previously, State Drug Controllers were responsible for issuing these two certificates. However, the... Read More
China's State Food and Drug Administration (SFDA) continues to ramp up plans to improve quality and increase regulations in the medical device arena. After setting up a trial Good Manufacturing Practice (GMP) scheme for sterile and implantable medical devices, SFDA issued the... Read More
More and more medical device companies are sourcing and manufacturing their products in China. However, given recent problems with heparin, di-ethylene glycol and melamine poisoning, quality issues have become paramount. What do you need to know about QA in China to be... Read More
Under Republic Act 9711 or the Food and Drugs Administration Act of 2009, the new FDA (former BFAD) will have expanded authority and increased regulatory capacity in the Philippines. The new law will help make it easier for the government to make... Read More
Despite the global economic downturn, the Indian medical devices market is growing at an impressive rate. India has a relatively young population of over 1.1 billion, and its economy has fared relatively well through the global economic crisis. Prime Minister Singh projects... Read More