JAPAN PAL UPDATE FOR FOREIGN MANUFACTURERS OF MEDICAL DEVICES
The Japanese Ministry of Health, Labor and Welfare recently issued an update to Notification No. 0709004, released last year, which outlined the dossier requirements for obtaining a foreign manufacturer certificate. According to the 2002 Pharmaceutical Affairs Law (PAL), any foreign medical device manufacturer must apply and be approved for a foreign manufacturer certificate before it can produce goods for sale in Japan.

The original PAL included a requirement for a doctor’s letter verifying that the foreign manufacturing plant manager did not have a mental disorder and did not use illegal drugs. The updated PAL now allows the plant manager to submit a “self-declaration” attesting to the above statements if it is impossible or difficult to get a doctor’s letter. However, the plant manager would also be required to explain why the doctor’s letter could not be obtained.

The dossier file for obtaining the foreign manufacturer certificate must also include information on the plant manager’s work experience and background, detailed descriptions of the goods to be exported to Japan and their manufacturing process, a list of all manufacturing equipment to be used, and any domestic licenses held in the manufacturer’s home country. Once granted, the foreign manufacturer certification is valid for five years.

HONG KONG HOSPITAL AUTHORITY IMPLEMENTS NEW DRUG FORMULARY
In July 2005, the Hong Kong Hospital Authority began implementation of its Drug Formulary, a list of over 1,200 standard drugs to be prescribed by doctors in public hospitals and clinics. Most drugs will not be affected by the Formulary, but there are approximately 70 non-standard drugs not on the Formulary that will no longer be subsidized by the Hospital Authority (HA). These include drugs that provide marginal benefits over currently available drugs at much higher cost; “lifestyle” drugs like impotence medication; drugs supported only by preliminary evidence; and drugs, such as cancer treatments, that have great benefit but are too expensive to be subsidized by a public health program. Patients who choose to take drugs not on the Formulary will either have to pay for them on their own or seek financial assistance from the Samaritan Fund, a government-funded safety net.

The Drug Formulary was created “to ensure equitable access to cost-effective drugs of proven efficacy and safety” while maintaining rational use of public resources. Between FY2003-04 and FY2004-05, the HA increased its drug spending by about HK$200 million (US$26 million), due in part to the rising costs of newly developed drugs and an aging population that incurs high medical expenses. It is too expensive for the HA to subsidize every new drug on the market. Standardization of drug policy and usage in HA hospitals and clinics will serve the public interest. Although a select minority of patients will be negatively impacted, the majority of the Hong Kong population will still have access to affordable, effective drugs. The Formulary will be implemented in phases across all HA hospitals over the next several months, and will be subject to review on a regular basis.

CHINA: MINISTRY OF HEALTH ANNOUNCES PROGRAM TO STRENGTHEN MONITORING AND REGULATION OF COSMETIC HYGIENE
The Chinese Ministry of Health announced the implementation of a supervisory program to strengthen the monitoring and regulation of cosmetics hygiene, beginning in April 2005 and lasting until the end of the year. The provincial health administrations will supervise more closely the enforcement of cosmetics hygiene in all production and marketing companies. They will also provide improved training for hygienic administrative authorities at all levels.

Health administrations will monitor cosmetics production companies to ensure that they have valid hygiene licenses. Companies that hold hygiene licenses are responsible for ensuring that their plants and warehouses are supervised and managed in accordance with the “Hygienic Standard of Cosmetics Production Enterprises.” In particular, they must refrain from any illegal use of cosmetic materials, and from the use of any forbidden materials as outlined in the Hygienic Standard.

Health administrations will also closely supervise cosmetics marketing enterprises such as hair and beauty salons, drugstores, and cosmetics wholesale markets, to examine their cosmetics’ labels and instruction sheets for any false or exaggerated claims. They will also perform periodic spot checks on key cosmetic products to assess their hygienic quality.

All health administrations are required to submit progress reports on the supervisory program to the Hygienic Supervision Center by the end of September 2005, and summary reports by the end of December 2005.

INDIA'S GOVERNMENT TO CREATE INDEPENDENT DRUG REGULATORY AUTHORITY
The Indian government has announced that it will create a new independent drug regulatory authority, to be called the Central Drug Administration or the National Drug Authority, which will be structured similarly to the U.S. Food and Drug Administration (FDA). India’s Minister of Health and Family Welfare, Dr. Anbumani Ramadoss, met with the FDA to discuss this issue during a recent visit to the U.S.

The drug regulatory authority will most likely be composed of around 10 departments each overseeing various issues; for example, drug safety, drug law enforcement, cosmetics, and biological products. It is anticipated to be functioning within two years. The government hopes to eventually set up a cooperative agreement with the FDA whereby regulatory approvals granted in the U.S. would be valid in India and vice versa.

The move to a centralized drug control system overseen by a national regulator is a response to recommendations by the Mashelkar Committee, a group of experts convened to examine the drug regulatory system in India. The regulation of drugs is currently decentralized, with individual state drug authorities reporting to the Drug Controller General of India in the Central Drugs Standard Control Organization. However, this system has led to inconsistency in the enforcement of drug laws and the quality of drug testing throughout the country. The creation of an independent drug regulator will hopefully lead to more rigorous and consistent regulation of drugs and higher quality standards overall.