When applying for a Certificate for Clinical Trial/Medicinal Test in Hong Kong, a summary of the pre-clinical studies (or alternate similar information) is now required as part of the application packet. The registration and payment may be submitted Monday through Friday, between... Read More
Effective January 1, 2004, the Singapore Health Sciences Authority (HSA) launched a consolidated Center for Drug Administration (CDA). The center was formed as a result of a merger between two of HSA’s former professional centers responsible for the regulation and evaluation of... Read More
Japan's complex medical marketplace has been significantly deregulated in the past several years. The government has also taken some measures to be more open to foreign businesses, thus allowing more foreign companies to enter Japan's medical market. Several business and regulatory strategies... Read More
From June 2003, registrations of new pharmaceutical products in Malaysia can be done online. The Malaysian government, through the National Pharmaceutical Control Bureau (NPCB) has established a comprehensive online registration system which allows manufacturers, license holders, and resellers of pharmaceutical products to... Read More
The Asian medical market is facing rapid changes as modernization greatly enhances the development of new and improved medical devices. Japan's recently revised Pharmaceutical Affairs Law (PAL) has maintained its basic purpose since 1948: to guarantee safety, efficiency and quality of medical... Read More
Many regulatory authorities in Asian countries are choosing to allow medical device product registration submissions to be done in electronic form. Previously, all governments required product registration applications to be completed in paper form, however, technical advances and the advent of a... Read More
Once a company registers its medical device product in Japan, there is often a question of whether to register its new or upgraded products as partial amendments to its existing Shonin or under a new me-too product application. According to the Ministry... Read More
The Ministry of Public Health in Thailand announced in late 2002 that it is drafting a new Medical Device Act. The new act will include revised registration requirements as well as regulations on product liability. The act will also outline the licensing... Read More
Indian drug manufacturers and the International Federation of Pharmaceutical Manufacturers Association (IFPMA), which represents multinational, research-driven, pharmaceutical companies around the world, recently clashed over the production of counterfeit drugs in India. In late January 2003, IFPMA accused the Indian pharmaceutical industry of... Read More
This article covers some of the changing dynamics of the regulatory scene in Asia for pharmaceuticals and medical devices, with information and updates from China, Korea, Japan and Taiwan. Drug prices and reimbursement rates have been cut as governments take steps to... Read More