Registering a medical product in Japan, from initial application to final approval, is known to be a very lengthy process, and could potentially become even more drawn out due to growing conflict over personnel issues at the PMDA. Many argue that one... Read More
The Marketing Authorization Holder (MAH) system in Japan came into effect with the new Pharmaceutical Affairs Law (PAL) in April 2005. It was designed to set up a specific structure for companies handling the importation, market release, and postmarket surveillance of medical... Read More
The Hong Kong Medical Device Control Office (MDCO) is planning to introduce a conformity assessment (CA) framework as part of its its Medical Device Administrative Control System (MDACS). The framework is intended to improve the quality management of medical devices. The CA... Read More
Amid discontent over Japan delay-ridden drug approval process, its regulatory authorities are making greater use of an instrument known as conditional approval. According to the Pharmaceutical Affairs Law, the Ministry of Health, Labor and Welfare (MHLW) can require the marketing authorization holder... Read More
In recent years, cancer has become a more salient issue in China. Currently, 1.5 million Chinese die of cancer annually, more than any other disease, and this number is growing fast. Chinese make up one quarter of all cancer sufferers in the... Read More
As a number of Singapore-based companies move into medical device production, government agencies are identifying the sector as a key growth area. Products which local companies have moved into recently include airway devices, infusion pumps, and gas detection equipment. These companies are... Read More
On March 1, 2006, a set of guidelines on the import and manufacture of medical devices, issued by the Drug Controller General of India (DCGI), became effective in India. (Subsequently, the effective date was postponed to June 30, 2006) Ten common sterile... Read More
On June 8th, 2006, the Japanese Diet passed an amendment to the Pharmaceutical Affairs Law concerning pharmacies sale of nonprescription OTC drugs. Prior to this amendment, the PAL rules on distribution had not been significantly amended since 1960, when the law was... Read More
A law that would allow the government to determine the prices of pharmaceuticals is close to being approved by the Philippine Congress, backed by consumer groups, health workers, clergy, and others. The Drug Prices Regulation Act of 2005 would create a board... Read More
In an effort to speed the approval process for foreign drugs in Japan, hospitals at six national universities, including Tokyo University, have come to an agreement to conduct clinical trials jointly. Under this agreement, called the “University Hospital Clinical Trial Alliance,” foreign... Read More