NEW ASSOCIATION OF SOUTHEAST ASIAN NATIONS (ASEAN) MEDICAL DEVICE INDUSTRY ASSOCIATION
ASEAN industry members assembled in the Philippines in January 2008 to announce committee members of the new ASEAN Medical Device Industry Association (AMDIA).

AMDIA is focused on representing the common regulatory interest of the medical device industry in ASEAN. It will also be committed in promoting an optimal regulatory environment for the continued development of the medical device industry. This new association will also help facilitate ASEAN harmonization initiatives through communications with local regulators and effective dissemination of information to industry members.

Other objectives for AMDIA include partnerships with ASEAN regulators and establishing regulatory convergence in ASEAN. In addition, AMDIA will carry out detailed work activities or deliberate on technical issues to provide recommendations to the ACCSQ MDPWG (ASEAN Consultative Committee for Standards and Quality – Product Working Group on Medical Device).

On January 23, 2008, AMDIA Committee members were announced for Indonesia, Malaysia, the Philippines, Singapore, Thailand, and Vietnam.

AMDIA Committee members will meet twice a year to coincide with ACCSQ MDPWG scheduled meetings. AMDIA is currently working on procedures for general membership, confidentiality issues, websites for posting of documents, and determining key areas for cooperation.

DISCUSSIONS ON REVISING REGULATIONS FOR BIOLOGICS IN JAPAN
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) recently held their second International Symposium on Biologics in January 2008. Summaries of this Symposium were recently made public. Senior Advisor Dr. Takao Hayakawa of the PMDA presented the current regulatory environment for biologics in Japan and also proposed new regulations for biologics.

Japan’s Ministry of Health, Labor, and Welfare (MHLW) currently regulates cell/tissue-based products based on two notifications. One is MHLW Notification No.266 (issued March 28, 2001) titled, “General Principles for the Handling and Use of Cells/Tissue-Based Products.” The other is MHLW Notification No.1314 (issued November 26, 2000) titled, “Guideline on Ensuring Quality and Safety of Products Derived from Processed Human Cells/Tissue.”

Dr. Hayakawa proposed revising these current guidelines. Specifically, he suggested developing specific guidelines for autologous cells/tissue-based products (same donor and recipient) compared to allogeneic ones and establishing a “kakunin shinsei” document. This “kakunin shinsei” document would provide data to confirm the quality and safety of a product before the product underwent investigational clinical trials.

As of now, there are no official guidelines for subsequent-entry protein products in Japan. “Subsequent-entry protein products” means any protein product that is produced using a new manufacturing process by a subsequent-entry manufacturer. This manufacturer may claim that their product is comparable or similar to an already existing protein product developed by an innovator. However, the new product has not been established as comparable or similar.

To demonstrate that subsequent-entry protein products are indeed comparable or similar, Dr. Hayakawa emphasized providing extensive CMC (Chemical Manufacturing and Controls) data and well-known established data. Subsequent-entry protein products cannot be defined as comparable or similar a priori.

Dr. Hayakawa also suggested extensive identification and characterization studies demonstrating the safety, purity, potency, identity and stability of the product. To ensure safety, Dr. Hayakawa also proposed that post-approval clinical studies may be necessary as data from pre-approval non-clinical and clinical studies may be insufficient.

PROPOSED OVERHAUL OF CHINA HEALTHCARE SYSTEM TO IMPACT MEDICAL INDUSTRY
With increasing out-of-pocket expenses and little to no support from the government, many people in China choose to not receive any medical care. Based on a national health survey taken in 2003, nearly 50 percent of people who should seek medical care do not. About 47% of urban citizens and 31% of rural inhabitants self-medicate instead of going to hospitals.

The vast majority of hospitals in China are still state-run and the costs for general medical supplies and services are controlled by the government. However, these state-run hospitals received minimal funding from the government for medical supplies and services.

Now China is planning to increase government spending so that more residents can afford medical care. The Chinese government is planning to expand and increase funding for clinics in both the rural and urban areas. In addition, the government would pay the salaries of doctors and staff. These clinics would be more primary-care focused and smaller than the larger state hospitals. Also, central and local government subsidies will be increased from about $5 to about $10 per person.

Increased government funding would lead to increased demand for various medical products, especially more basic, Class I medical devices.

THAILAND TO IMPLEMENT COMPULSORY LICENSING FOR CANCER DRUGS
Thailand’s Public Health Minister Chaiya Sasomsab has announced his decision to push forward with compulsory licensing for drugs. Despite protests from industry members such as the Pharmaceutical Research and Manufacturers Association (PreMA) to implement this decision, Chaiya plans to push forward on this policy.

Chaiya believes that compulsory licensing will save money for the benefit of patients to get access to quality drugs at a cheaper price. Compulsory licensing would allow the country to produce or import generic versions of patented drugs for emergency use. However, opponents believe that this compulsory licensing could end up hurting the country’s trade and eventually affect the economy. In addition, PreMA believes that compulsory licensing should only be used as a last resort when all other options are not viable.

NEW REGULATIONS FOR PHARMACEUTICAL PRODUCTS IN MALAYSIA
Both local and foreign drug manufacturers will have to obtain pre-market approval with stringent testing to be certified fit for sale. Manufacturers must submit a document listing the benefits and function of the drug, including ingredients.

Malaysia’s Health Ministry Food Safety and Quality Control division has said that drugs will not be allowed on the shelves until they meet these requirements.

In addition, approved drugs will receive a serial number for easy tracking. Drugs will also require proper labeling and no false advertising with exaggerated will be allowed. The Health Ministry will also not allow any products claiming to be recommended for those with cancer, kidney problems, diabetes, and hypertension without proper scientific support.

Malaysia plans to implement this system in stages.