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
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
Despite the social hardships, economic stagnation has been a catalyst in Japan for the relaxation of regulatory control in the pharmaceutical industry. In the 1980s and early 1990s, the Japanese government restricted the entry of foreign drugs in order to assist local... Read More
The Japanese Health Insurance Reform Bill was enacted at the end of July 2002. This reform will shift health care cost burdens towards the active workers and the elderly. The main changes as a result of the bill are as follows: Co-payment... Read More
The Ministry of Science and Technology as well as other governmental bodies in China are considering the implementation of a tax break or exemption for companies that invest in new drug development. Up to this time, China has not been a major... Read More
Slowing economies have not stopped Asian countries from moving ahead with medical device regulatory reforms. Asian consumers demand high-quality healthcare products, making it worthwhile for American manufactures to be active in the region. Procedures and practices vary according to country. This article... Read More
Controversy has arisen between US drug manufacturers and the Korean government regarding the reform of South Korea’s national health insurance system and its affects on drug pricing. Proposals have been made by Korea’s Health Ministry to implement a new reference pricing system... Read More
The Japanese House of Representatives passed and enacted the revised Pharmaceutical Affairs Law on July 25, 2002. The revision of the law will facilitate start-up pharmaceutical and medical device companies that do not have production facilities in Japan to enter into the... Read More
Scientists in Singapore will be allowed to withdraw stem cells from adult human tissues, aborted fetuses, and surplus embryos less than 14 years old for research purposes, according to new guidelines approved by the Central Government July 17, 2002. The cloning of... Read More
No drug can be imported, manufactured, stocked, sold or distributed in India unless it meets the quality and other standards laid down in the Drug and Cosmetics Act 1940 (DCA). For patent or proprietary medicines (medicines not listed in the Indian or... Read More