When applying for a Certificate for Clinical Trial/Medicinal Test in Hong Kong, a summary of the pre-clinical studies (or alternate similar information) is now required as part of the application packet. The registration and payment may be submitted Monday through Friday, between... Read More
The race is on among foreign pharmaceutical manufacturers to meet the needs of Japan’s increasingly aging female population. Demand for treatments for osteoporosis, breast cancer, and other post-menopausal ailments is expected to grow in line with the rising number of women suffering... 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 Ministry of Culture and Information and the Ministry of Health have jointly issued two updated guidelines on health and medical products advertising. The guidelines apply to advertisements for health-related matters, such as check-ups and treatment, medications, cosmetics that influence health, vaccines,... Read More
A Ministry of Health, Labor and Welfare (MHLW) panel has recommended reclassifying 350 drugs and allowing them to be sold as over the counter (OTC) medications at convenience stores. Types of drugs include intestinal remedies, gargles, antiseptics, vitamin-based remedies and cough rubs.... Read More
From July 1, 2004, the sale of over the counter antibiotics will be severely limited in China. Antibiotics not included in a list of legitimate OTCs can only be sold with a doctor’s prescription. Popular drugs like penicillin and sulphonamide, now commonly... Read More
The Singaporean government plans to institute new laws by the middle of 2004 to regulate the sale of health supplements in the country. This decision was made in response to two deaths, one of a local actress, occurring in 2002 as a... Read More
To curtail a shortage in pharmacists at government hospitals, Malaysia has instituted a new law requiring pharmacy graduates to spend three years working in the public sector before being allowed to move on to the private sector. Only about 19% of practicing... Read More
Home to a booming population and low costs, India is rapidly becoming a preferred destination for drug companies to conduct clinical trials quickly and cheaply. Performing clinical trials in India can be 50%-60% cheaper than in North America or Europe. Other practical... Read More