One of the main purposes of the recent revisions in Japan’s Pharmaceutical Affairs Law (PAL), which was passed into legislation in 2002, was to place a greater burden of responsibility for companies to assure quality. The Ministry of Health, Labor and Welfare... Read More
The Institute of Nuclear Medicine & Allied Sciences released a proposal to the Indian government in the summer of 2003 to establish a system to regulate and supervise medical devices in the country. Currently, India does not have a regulatory body to... Read More
As part of the extensive Pharmaceutical Affairs Law (PAL) revisions in Japan, the Japanese government has instituted changes to their current regulations in order to consolidate safety measures for biological products. The regulatory changes for biological products were introduced in July 2003.... Read More
The recent recall of over 200 health care products in Singapore has caused the Health Sciences Authority (HSA) to investigate ways to strengthen their regulatory control of health care products, particularly, health supplements. On May 9, 2003, the HSA recalled products produced... Read More
Japan’s recent food-related scares have prompted the Japanese government to take more serious measures in addressing the country’s food safety. Last year, Snow Brand Food Products Co., was involved in highly publicized scandals involving the distribution of foreign meats labeled as domestic... Read More
In November 2002, China’s State Drug Administration (SDA), which has been replaced by China’s new Food and Drug Administration, issued an official memorandum announcing new regulations related to diagnostic products. The memorandum indicated the following basic guidelines: Both the drug and medical... Read More
A third-party certification system for low-risk medical equipment will be introduced through Japan’s Pharmaceutical Affairs Law (PAL) revisions within the next two years. Products designated by the Ministry of Health, Labor and Welfare (MHLW) as medical equipment requiring controls, or Designated Medical... Read More
The Pharmaceutical Affairs Law (PAL) that passed legislation in Japan last year included four major revisions that are noteworthy to foreign medical device manufacturers: Revision of the measures for safety related to medical devices, Enhancement of the measures for safety after marketing,... Read More
In order to create a more integrated system for Japan’s medical regulatory process, the Ministry of Health, Labor and Welfare signed a bill at the end of 2002 establishing a new independent administrative institution. The new institution will unify the Organization for... Read More
In January 2003, the Shanghai Drug Administration Bureau announced its resolve to tighten controls over pharmaceuticals and drug distribution as well as create more efficient systems for reporting adverse reactions to medication. According to recent reports by the bureau, of 14,980 drugs... Read More