JAPAN ISSUES GUIDANCE ON MEDICAL DEVICE GCP COMPLIANCE REVIEWS
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has issued guidance (Notification 0715006, July 2005) on GCP compliance reviews of clinical trial documentation for medical device shonin applications. Both the MHLW and the Pharmaceuticals and Medical Devices Agency (PMDA), the consultative arm of the MHLW, will conduct compliance reviews.

The GCP compliance reviews will include examinations of both the reference documents as well as the medical device clinical trial sites to ensure that all clinical trials have been conducted in accordance with Japanese GCP. The document review will encompass all reference documents generated in the clinical trial, including the protocol, reports on monitoring, adverse events, data collection and analysis, and clinical results, as well as the clinical trial summary report. The PMDA will review these documents when the shonin application is submitted to the PMDA. The MHLW may review these documents in special circumstances where the MHLW questions the credibility of the documentation.

Representatives from the PMDA will travel to the clinical site to conduct a site audit. The government representative will then generate a summary report of the audit. The shonin applicant will then receive a designation of GCP compliance or non-compliance. After receiving a negative ruling of non-compliance with GCP, the applicant may undergo a re-evaluation by submitting additional information to the PMDA in support of the shonin application.

Any applicant that refuses an audit or presents false information will automatically be given a non-compliance judgment. Clinical trial documents that have already been submitted in a previous shonin application dossier, or documents that are part of a dossier that has already obtained shonin approval, are exempt from the review.

VIETNAM ’S NEW PHARMACEUTICAL LAW TAKES EFFECT IN OCTOBER 2005
Vietnam ’s new Pharmaceutical Law, approved by the Vietnamese National Assembly in May 2005, will go into effect October 1, 2005. The Pharmaceutical Law addresses the development of the domestic pharmaceutical industry and State control over drug pricing, in addition to other issues such as advertising and drug testing. The new law prioritizes the transformation of the pharmaceutical industry into a key industry for the Vietnamese economy.

One of the most significant issues addressed by the Pharmaceutical Law is the increased regulation of drug prices. All pharmaceutical importers and distributors must submit their price lists to the Drug Administration, and any plans to increase prices must first be approved by the Drug Administration. In addition, the Drug Administration intends to deny approval of any price increase exceeding those prices in “comparable neighboring states.” Unauthorized price increases will be “severely punished.” Responsibility for overseeing the drug pricing policy will be shared jointly by the Ministries of Health and Finance, in addition to other state authorities.

Drug pricing has been a highly contentious issue between the Vietnamese government and pharmaceutical companies. Drug prices in Vietnam increased by almost 10% between 2003 and 2004, and have risen again in 2005, by anywhere from 5 to 50%. Price stabilization measures have been undertaken by the government in the past to control the rise of drug prices, but they have continued to rise.

The Pharmaceutical Law aims to develop the competitiveness of the domestic drug industry. Former Minister of Public Health, Deputy Do Nguyen Phuong, stated that local production supplies only 40% of domestic demand, leaving 60% to be met by imports. All pharmaceutical companies in Vietnam, domestic and foreign, will be subject to the Pharmaceutical Law.

CHINA PLEDGES TO IMPLEMENT OTC DRUG PRICE CUTS
The Chinese government has pledged to follow through on substantial drug price cuts announced earlier this year as part of a new OTC pricing reform. On October 10 th, prices of 400 medications (mostly antibiotics) will be cut by an average of 40%, with some to be cut by as much as 63%. The National Development and Reform Commission (NDRC) had proposed a plan to cut the retail prices of 22 drug categories that was to begin August 1, 2005, but since then little had been done to implement the plan. The government estimates that the price cut will generate savings of about CNY4 billion (US$494 million). The 22 drug categories were chosen because they are commonly prescribed to patients.

The Chinese government renewed its commitment to lower drug prices in face of increasing unrest and dissatisfaction amongst Chinese citizens who are unable to afford medication or doctor’s visits. Retail drug prices can be substantially higher than wholesale prices, due in part to hospitals’ pricing practices. A substantial portion of hospital revenues comes from drug sales, which can lead to high mark-ups and the prescription of unnecessary drugs.

This price cut is the latest in a series of drug price cuts implemented by the Chinese government in the past several years.

MALAYSIA MINISTRY OF HEALTH OFFERS FURTHER GUIDANCE ON THE MEDITAG SECURITY DEVICE FOR PHARMACEUTICALS
The Ministry of Health in Malaysia has issued further guidance on the requirement for all registered pharmaceutical products to be labeled with a Meditag, a hologram security device. The Meditag was initiated by the government in an effort to combat the flood of unregistered imitation drugs and health products. All products registered with the Malaysia Drug Control Authority, including traditional medicine and health supplements are required to bear the Meditag. Cosmetics and OTC external care products such as antibacterial, oral care, or anti-acne products are currently exempt from this requirement.

Anyone who fails to abide by this law will be subject to a fine, imprisonment, or both. First-time offenders will be fined up to RM25,000 (US$6,632) and/or jailed for up to 3 years. Second-time or subsequent offenders will be fined up to RM25,000 (US$6,632) and/or jailed for up to 5 years. Any corporate entity failing to abide by this law will be charged a fine of RM50,000 (US$13,264) for first-time offenders or RM100,000 (US$26,529) for second-time or subsequent offenders.