JAPAN: NEW AGENCY FOR FASTER DRUG APPROVAL
Three major agencies responsible for drug and medical device approval in Japan merged into one organization called the Pharmaceuticals and Medical Devices Agency (PMDA), on April 1, 2004. Previously, the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), Organization of Pharmaceutical Safety and Research (OPSR) and the Japan Association for the Advancement of Medical Equipment (JAAME) were separate organizations, all in charge of the drug and medical device approval process. The creation of the PMDA will consolidate the work of the these three organizations and will make the drug and medical device approval process, including managing consultations for clinical trials, product reviews of approval and licensing applications, and side-effects monitoring, much more timely and efficient in Japan.

Akira Miyajima, the head of OPSR, believes that the new agency will put Japan on the same level as the U.S. FDA and European Agency for the Evaluation of Medicinal Products, approving drugs in an average of 12-16 months. Previously, Japan’s drug approval process could take up to 20 months. By 2009, the PMDA hopes to approve about 80% of drugs within a 12 month period, up from the current rate of 50%.

Additionally, under the PMDA, a fast-track approval process has been initiated for all orphan drugs and devices. Applications for fast-track approval will need to be submitted before any pre-approval consultations can take place and will cost about 751,500 yen (US $6,900). Drugs and devices meeting fast-track criteria – drugs or devices used to treat deadly, life-threatening diseases – will be eligible for this expedited review and approval process.

However, the new agency has a long way to go before it reaches the same approval level as the U.S. and Europe. The agency currently has a shortage of qualified staff and is aiming to boost its staff members from 317 to 357 employees in the next several years. Moreover, it is possible that drug approval fees could double, increasing fees to as much as 16 million yen (US $150,000) per drug. However, analysts say that these higher fees will not hurt a company’s profits, as a drug will be able to hit the pharmaceutical market much sooner with the PMDA’s speedier approval process.

VIETNAM: INCREASED OPPORTUNITIES FOR FOREIGN DRUG MANUFACTURERS
Increasing drug prices in Vietnam prompted Vietnam’s Ministry of Health (MoH) to adopt a series of measures to efficiently control drug prices and drug imports and stabilize the country’s pharmaceutical market. Beginning in June 2004, foreign pharmaceutical companies holding operating licenses in Vietnam could begin supplying pharmaceuticals to any local import-export company in Vietnam, so long as the local distributors or manufacturers could not supply the drug, or could only supply it at a very high price. Previously, foreign firms were only permitted to sell their products to local Vietnamese companies holding registered drug trademarks. This new regulation will help end the monopoly on foreign imports held by local trademark-holding companies and enable foreign companies to increase their presence in the Vietnamese pharmaceutical market.

The MoH will implement additional regulations for the importation and distribution of foreign drugs in Vietnam. For instance, in April 2004, the MoH established a panel, which will meet once a week to review license applications for the approval of drugs not yet registered for distribution in Vietnam. This new panel should help speed up the license application review process. Additionally, plans have been drafted for several projects which will help ensure an adequate drug supply for the domestic market, expand the domestic drug market and improve the management of drug trading and production. Moreover, the number of pharmaceuticals imported into Vietnam should increase from its current 60% with the introduction of these new drug regulations.

HONG KONG LAUNCHES CENTER FOR HEALTH PROTECTION
On June 1, 2004, Hong Kong’s Department of Health launched the Center for Health Protection (CHP) under the recommendation from the SARS Expert Committee Report. The CHP will help strengthen Hong Kong’s ability to prevent and control communicable diseases. In order to pool professional knowledge and expertise on communicable diseases, the CHP set up a Board of Scientific Advisors, a panel of local and international experts. Through the establishment of the CHP, Hong Kong will be better able to handle health threats and outbreaks of diseases.

The Board of Scientific Advisors is supported by six committees, each responsible for a different function within the CHP. These committees will encourage communication between local healthcare professionals, community members, academics, Hong Kong government departments, and international healthcare authorities. The six branches are as follows: Program Management and Professional Development Branch, Public Health Laboratory Services Branch, Public Health Services Branch, Surveillance and Epidemiology Branch, Emergency Response and Information Branch and the Infection Control Branch. Some of the key functions of these committees include disease surveillance, risk communication, training in infection control for all healthcare professionals, and the establishment of an emergency preparedness plan to tackle the outbreak of a disease. Additionally, the CHP committees will also provide for the creation of a central communicable disease information system, offering healthcare professionals regular reports on the latest communicable diseases and infections of concern in Hong Kong.

MALAYSIA’S MINISTRY OF HEALTH INTRODUCES THE TRADITIONAL AND COMPLEMENTARY MEDICINE ACT
In May 2004, Malaysia’s Ministry of Health announced the drafting of the Traditional and Complementary Medicine Act. This Act will provide guidelines to better regulate traditional and complementary medicine (TCM) practices in Malaysia by integrating them into the country’s National Healthcare System.

The use of traditional and complementary medicine is widespread among developing nations and is gaining popularity among developed countries. According to the World Health Organization (WHO), approximately 66% of the population in developing countries uses TCM on a regular basis, and about 50% of the global population in developed countries.

In accordance with the TCM Act, all TCM practitioners will be required to register with the Ministry of Health. Currently, 3,000 TCM practitioners have already voluntarily registered, even though the Traditional and Complementary Medicine Act will not go into effect until 2006.

Once the TCM Act is implemented, registration with Malaysia’s Ministry of Health will become mandatory for all TCM practitioners. However, registration alone will not guarantee automatic approval or endorsement by the Ministry of Health. The practitioner will still be required to meet certain standards and many aspects of the practitioner’s operation will be monitored, such as the products used to treat patients, quality of the products, methods of treatment, safety, and scientific evidence showing effectiveness of these TCM’s. A standing committee made up of representatives from the Ministry of Health, Malaysian Medical Association (MMA), and various practitioner’s groups and universities in Malaysia, is working to create a module which will cover the issues of TCM education, consultation and monitoring.