India’s National Policy for the Containment of Antibiotic Resistance On April 11, 2011, the Indian government released its National Policy for the Containment of Antibiotic Resistance. This is the government’s first policy that regulates the use of antibiotics in India. This policy... Read More
Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has developed an online system for the submission of registration applications for medical devices in Japan. The online portal, known as DWAP (WEB medical application platform), started accepting electronic applications with effect from April 25,... Read More
Malaysia will soon introduce its Medical Devices Act by the end of 2011. This Act is expected to be established when the current Medical Devices Bill 2008 is presented to the Malaysian Parliament either at the end of March 2011 or in... Read More
China has gained economic strength despite the global recession of 2008-2010. As the world's second-largest economy behind the United States, China's gross domestic product growth of 10.3 percent in 2010 was significantly stronger than Organisation for Economic Cooperation and Development (OECD) countries'... Read More
On January 19, 2011, newspapers in Japan published an announcement from the Ministry of Health, Labour and Welfare (MHLW) on an upcoming change to the good manufacturing practice (GMP) compliance audit. It had been previously announced that manufacturers creating products that are... Read More
Following its recent medical device regulation overhaul, Singapore’s Health Sciences Authority (HSA) is planning to carry out further adjustments to the nation’s medical regulations. At present, there are a number of different notifications that collectively operate to control the importation, sales and... Read More
On December 27, 2010, China’s State Food and Drug Administration (SFDA) website was updated with an announcement on 96 new industry standards that will affect medical devices in China. 34 of these new industry standards are mandatory (labeled YY) while the remaining... Read More
On December 21, 2010, representatives from Taiwan and China met to sign a new agreement that supports the bio-technology industries of both territories. Two important outcomes of this agreement include upcoming cooperation on clinical trial standards and vaccine development. With clinical trial... Read More
The SFDA issued “Requirements on Application Dossiers in Common Technical Document (CTD) Format for Pharmaceutical Products” in late September 2010. The release of this CDT format for Pharmaceutical Registration Applications continues China’s trend of integrating with international regulatory standards. Through further integration,... Read More
On October 20, 2010, the Philippines’ Food and Drug Administration (FDA) under the Department of Health requested comments on a draft of the new administrative order for GMP of foreign drug manufacturers. The guidelines serve to establish a formal system of evaluation,... Read More