Japan’s new Pharmaceutical Affairs Law (PAL) will be fully implemented in April 2005. Included in the changes will be the new requirement that all low-risk medical devices, or controlled medical devices, be evaluated by a third party organization. Japan’s Ministry of Health, Labor... Read More
Due to the government’s concern of the manufacturing and importing of counterfeit and unregistered pharmaceuticals in Malaysia, the Ministry of Health has recently issued the “Directive on the Use of the Hologram Security Device.” This regulation will require all pharmaceuticals, including health... Read More
In response to concerns about the safety and effectiveness of pharmaceutical manufacturing in China, the State Food and Drug Administration (SFDA) will require Good Manufacturing Practice (GMP) authentication for all Chinese pharmaceutical manufacturers. The regulation goes into effect on July 1, 2004,... Read More
In a move to ensure standards of quality, efficacy and safety in medical products, India’s Central Drug Standard Control Organization has revised its guidelines on bioequivalence and bioavailability for pharmaceuticals. The revisions will become part of Schedule Y of the Drugs and... Read More
The Drug Import Regulation, issued by the State Food and Drug Administration and in effect since January 1, 2004, allows for the faster sale of imported medicine. Imported drugs can now be sold immediately upon clearing customs. Previously, the sale of imported... Read More
Good Manufacturing Practice (GMP) standards were initially introduced in China in 1992. The standards provide basic rules and requirements pharmaceutical manufacturers in Mainland China must abide by in order to ensure the quality of drug products. In order to obtain GMP certification,... Read More
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