Japan’s Ministry of Health, Labor, and Welfare plans to implement a new rule requiring prescription drugs to have bar codes in order to reduce dosage errors. The first phase is planned for the summer of 2005. Later this year, a panel of... 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
A panel headed by Dr. R.A. Mashelkar, Director General of the Council for Scientific and Industrial Research (CSIR), recommended in its report that Phase I clinical trials be allowed in India concurrently as they are being conducted abroad. Phase I clinical trials... Read More
The Ministry of Health, Labor and Welfare (MHLW) and the Ministry of Education, Culture, Sports, Science, and Technology (MECSST) in Japan jointly unveiled their “Three-Year National Drug Clinical Trial Action Plan” on April 30, 2003. The plan, which will run from 2003... Read More
Singapore’s Health Sciences Authority (HSA) has been developing an electronic licensing system to support the regulatory functions of the Centre for Pharmaceutical Administration (CPA) since 2001. The HSA implemented the first part of its electronic system in April 15, 2003 with the... Read More
In July 2003, Hong Kong’s Department of Health (DH) and the Electrical and Mechanical Services Department (EMSD) together released a consultation document entitled “Regulation of Medical Devices in Hong Kong.” Currently, Hong Kong does not have any specific legislation which regulates the... 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
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
One of the main revisions of the Japanese Pharmaceutical Affairs Law (PAL) that was passed in 2002 will be the re-categorization of medical devices. The Japanese medical devices classification system will be revised in the PAL to take into account the risks... 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