IMPROVING GLOBAL DRUG DEVELOPMENT: CHINA, JAPAN, AND KOREA
The East Asian Pharmaceutical Regulatory Symposium was recently held April 14-15 2008 in Tokyo. At the Symposium, the Health Ministers of China, Japan and Korea agreed to promote increased clinical data sharing and encourage global drug development.

The three Ministers affirmed the importance of the three countries’ cooperation on clinical research, especially in clarifying the ethnic factors on clinical data. The State Food and Drug Administration of China (SFDA), the Korea Food & Drug Administration (KFDA) and the Ministry of Health, Labor and Welfare of Japan (MHLW) plans to establish a Joint Research Project on Ethnic Factors in Clinical Data. These ministries will also develop an Information Exchange Scheme on general pharmaceutical affairs.

To coordinate these projects, each country will have a contact point. For the SFDA, it will be the Department of Drug Safety Inspection. For the KFDA it will be the Pharmaceutical Safety Policy Division, while for the MHLW, it will be the Pharmaceutical and Food Safety Bureau, Evaluation & Licensing Division.

These three countries would work together to make sure information is shared, especially with experiences and direction for improving clinical development. The hope is to provide increased networking and collaboration in the Asian region to develop the best fit drugs for Asian populations.

The symposium also discussed the latest trends and updates in Good Manufacturing Practice (GMP) and clinical trial monitoring.

A working group (WG) will be established to promote these projects. The first WG meeting is scheduled for November 2008 in Japan.

ISSUE OF OVERLAPPING MEDICAL DEVICE BILLS IN INDIA
Medical devices in India are largely unregulated at this point. To address this issue, the Department of Science and Technology (DST) had proposed a Medical Devices Regulations Bill, while the Health Ministry had proposed a similar bill to establish a Central Drugs Authority (CDA).

As reported in earlier newsletter issues, the Medical Devices Regulations Bill proposes setting up a centralized authority to establish standards and ensure compliance for medical devices in India.

The CDA would also be a completely centralized licensing system. It would be responsible for issuing manufacturing licenses for medical licenses, conducting standards and quality monitoring, ensuring compliance, etc.

With such overlap, the Ministry of Health and Family Welfare has asked the DST to not go ahead with its proposed Medical Devices Regulations Bill. As of now, DST has not stated if they will formally withdraw their bill. There have been discussions of making the two bills complementary and combining the two. DST officials have also stated that establishing accredited laboratories to test and certify medical devices could be included so that the new central authority is not overwhelmed.

REFORMS FOR VIETNAM'S PHARMACEUTICAL MARKET
At a recent Vietnam pharmaceutical industry meeting, healthy ministry officials stated that drug regulations needed to be ramped up and drug prices regulated more strictly.

Vietnam’s pharmaceutical companies mostly manufacture generic products for simple illnesses. Many specialized drugs such as HIV and cancer prevention drugs are imported and sometimes illegally smuggled into the country. The Drug Administration of Vietnam found that almost 0.2 percent of drugs on the market were fake, higher than the year before in 2006. In addition, random drug samples revealed that a little more than 3 percent of test drugs did not comply with safety standards.

At the industry meeting, recommendations were raised to increase investment in local drug production. Health minister officials also hope to more strictly manage drug quality and price. One suggestion was to post drug prices online for easy reference and enforcement of pricings. Other plans to improve the local pharmaceutical industry included establishing zone area for growing raw materials for drugs and having the Ministry of Health work with the Ministry of Education and Training to create a qualified human resource pool for this sector. The Ministry of Health also plans to set up research facilities for biotech products and vaccines.

MALAYSIA'S HEALTH MINISTRY TO REVIEW HOSPITAL CHARGES
Malaysia’s Ministry of Health will review private hospitals’ charges for medical devices and pharmaceuticals due to complaints of excessive fees. Currently, the Ministry has the Private Hospital Act to control medical expenditures. However, this Act only regulates doctors’ fees.

The Ministry of Health will also meet with the Malaysian Medical Association, Association of Private Hospitals of Malays and consumers association to get additional feedback.

Though fees may be increasing for some services, Malaysians can receive funding and financial assistance through the Health Ministry’s Medical Assistance Fund and the National Heart Institute Foundation. The fund is available for patients suffering from HIV/AIDS, cancer, Parkinson’s disease, kidney and heart disease and also for long-term medical treatments. Last year, the MAF provided more than $7 million in financial aid.

KOREA'S HEALTH MINISTRY TO ENCOURAGE GROWTH IN MEDICAL INDUSTRY
Korea’s Ministry of Health, Welfare and Family Affairs stated that it would revise regulations and increase support for the medical tourism industry. By October 2008, the ministry plans to revise the current medical law restricting marketing by medical institutions. Medical institutions would be allowed to provide transportation services to foreign patients and also hire and pay partner travel agencies.

In addition, the ministry also plans to build a high-tech medical park by 2011 to promote R&D of new medical devices and pharmaceuticals. The ministry hopes to issue a draft plan of the proposed park before 2009.