DRUG MAKERS TARGET JAPANESE WOMEN
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 from such diseases.

Increasing demand has prompted manufacturers to step up their efforts in conducting gender-specific research and developing female-only drugs. The Japanese arms of Eli Lilly and Pfizer, both of the U.S., and Schering, of Germany, are all actively working on gaining approval for new women’s medication. The market for female-only products is recognized as largely untapped and a source of potential growth. Schering, for example, currently derives 10% of its overall Japanese sales from female products, but has a stated goal of raising that figure to 30%.

Interest in gender-specific medication from drug makers mirrors an escalating interest in women’s medical issues among healthcare professionals. Research has shown that women are prone to different diseases and react to medication differently than men. Europe and North America discovered this in the 1980s, but Japan was slow to recognize the phenomenon. However, the establishment of several women’s clinics and hospital departments in recent years has provoked awareness for female health concerns as well as the potential market for female-only drugs.

CHINA: GMP CERTIFICATION REQUIRED BEGINNING JULY 1, 2004
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, and requires that all of the country’s 6,000 drug manufacturers comply with GMP regulations.

In 1998, China introduced but did not insist on GMP authentication, emphasizing a quality approach to manufacturing by promoting the production of safe and effective pharmaceuticals. However, concerns have arisen due to numerous medical accidents and legal issues resulting from unqualified manufacturers. Compliance with GMP regulations will allow Chinese drug makers to increase productivity, quality and safety through the modernization of manufacturing equipment and technology.

Approximately half of Chinese drug manufacturing companies have met Chinese GMP standards to date. An additional 1,000 companies are in the process of upgrading their technology, and thereby receive a six month grace period to meet the GMP requirements. If the minimum technology requirements are not met by December 31, 2004, the company will lose its license and be forced to close. Therefore, it is possible that approximately 20-30% of Chinese drug manufacturing companies could be closed down by the end of this year, due to non-compliance with GMP regulations.

INDIA REVISES BIOEQUIVALENCE GUIDELINES
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 Cosmetics Act and new drug applications will have to meet these requirements.

The revisions indicate how a comparative study should be executed, the design requirements, study population, the characteristics that need to be studied, facts of the bioanalytical methodology required, and parameters for statistical evaluation of the results.
Drugs subject to bioequivalence tests include: oral immediate release drug formations with systemic action; non-oral and non-parenteral drug formulations designed to act by systemic absorption; sustained or otherwise modified release drug formulations designed to act by systemic absorption; fixed-dose combination products with systemic action; and non-solution pharmaceutical products which are for non-systemic use and intended to act without systemic absorption.

VIETNAM GETS STRICT ON HEALTH PRODUCTS ADVERTISING
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, bio-products, medical equipment, and food, chemicals, insecticides and antiseptics used in household appliances or the health sector.

The guidelines are:

• Advertisements for medical check-ups and treatment must not overstate the qualifications of the health professionals involved. Furthermore, only procedures and practices approved by the Ministry of Health can be advertised.
• Advertising is not allowed for pharmaceutical products and medical equipment that is prohibited in Vietnam, as well as poisons, addictive drugs, prescription drugs, and centripetalneurotropic substances.