CHINA CONTINUES TO CRACK DOWN ON MEDICAL MARKET
China’s State Food and Drug Administration (SFDA) has recently issued various laws to regulate more stringently quality control in the medical market. The US Department of Health and Human Services (HHS) is also helping China improve its medical market. The HHS and China are currently in negotiation to establish memoranda of agreements on food, drugs, and medical devices.

The SFDA has already issued registration procedures for imported medical devices, to clarify the product registration process and establish evaluation of the application at each stage. From application acceptance to final approval, technical details, safety and efficacy will be checked and reviewed. The application and technical evaluation will be verified to ensure that everything has been administered properly. The SFDA has also established time limits for each stage of the product registration and approval process.

To address issues of corruption, the SFDA has also issued prohibitive rules for personnel involved in food and drug supervision. These rules prohibit such activities as direct or indirect ownership of stocks of medical-related companies, collecting any fees for lectures, and receiving gift vouchers or expensive gifts. Depending on the misdemeanor, violators may be internally reprimanded, face disciplinary action, or be turned over to the judicial authorities.

In addition to new regulations, the SFDA has also proposed systems for supervising and revising medical device industrial standards and requirements on recalls. Manufacturers failing to recall defective or unsafe medical devices will be subject to fines and possible production license seizure. Manufacturers may also face criminal charges if unrecalled products result in serious adverse events.

MALAYSIA PROPOSES A MEDICAL DEVICE REGULATORY SYSTEM
Malaysia’s Ministry of Health (MOH) has been working for several years on gradually establishing a medical device registration system. In February 2005, they announced the Medical Device Voluntary Establishment Registration program, abbreviated MeDVER. Implemented in January 2006, this is a system where medical device companies can voluntarily register lists of their devices (not registering devices individually).

To establish MeDVER more fully in the near future, the MOH has recently drafted a proposed medical device regulatory system. The proposal encompasses the monitoring and supervision of medical devices from the pre-marketing to post-marketing stage. This medical device regulatory system would strive for global harmonization.

Medical devices would be divided into four risk classes. 16 rules would be used to determine the risk class of the medical device.

All phases of the medical device would be monitored, from design and development to adverse event reporting. Pre-market review would involve safety and performance checks in addition to checking compliance with labeling requirements.

Product registration would be required for all medical devices except those classified as low-risk (Class A). The MOH has listed three possible options for demonstrating the safety, effectiveness, and quality of a medical device. These options include regulatory approval from the US, EU, Australia, Canada, and Japan, submission of a certificate issued by a conformity assessment body, or submission of technical documentation and clinical data for assessment.

Class A products would only require a notification without a pre-market assessment. Manufacturers would need to maintain and let the Ministry know of the list of Class A products they have placed into the market.

All local manufacturers who manufacture or re-package devices sold in Malaysia will need to be licensed. Manufacturers will be required to perform post-market surveillance and adverse event reporting. Manufacturers must also establish a system to collect post-market surveillance data of high-risk medical devices to receive product approval and ensure product safety.

Local representatives (of imported Class B or higher devices) must also be registered, and can be any private company appointed to represent the manufacturer.

Quality systems will also be required, though the MOH has not decided the specifics on the structure. Audits, either by the government or third party agencies, may occur to review the quality system and ensure product quality.

The currently operating MeDVER allows online registration at www.medicaldevices.gov.my.

INDIA TO WITHDRAW LICENSES OF IRRATIONAL COMBINATION DRUGS
Based on a meeting of State drug controllers organized by the Drug Controller General of India (DCGI), over 30 combination drugs have been ordered for removal from the market. In addition, the review of over 1,000 other combinations drugs has also been proposed.

Combination drugs are considered new drugs in India and require prior marketing approval from the DCGI. The DCGI has issued lists outlining the banned drugs, which includes pain-killers, gastro-intestinal medicines, and central nervous system drugs. Manufacturing licenses would also be withdrawn for these banned products.

The DCGI has ordered immediate removal of these banned products without allowing companies the opportunity to establish “rationality” of their combination products. The Indian Pharmaceutical Alliance, an organization consisting of major pharmaceutical firms in India, has proposed an assessment system for these banned drugs. This way, companies would have the chance to present quantitative data and expert opinions to support their combination product. At this point, the DCGI has not made any comments on this assessment system.

The review of over 1,000 combinations would consist of those drugs approved by the State and not the main DCGI. The list includes drugs in various fields, from anti-microbials, cardiovascular, gastro-intestinal, cough and cold, and central nervous system. Many of the companies listed are Indian, though there are a few multinationals such as Merck and GlaxoSmithKline also under review. The Central Drugs Standard Control Organization (CDSCO) has said only irrational combinations would be removed after review.

CLINICAL TRIAL MEDICINES FOR INCURABLE DISEASE PATIENTS IN KOREA
The Korean Cabinet recently passed a bill to allow the use of clinical trial drugs for patients suffering from serious illnesses having no alternative treatment options. This bill is a revision to the current Pharmaceutical Affairs Law and was approved August 28, 2007.

After approval from the Korea Food and Drug Administration (KFDA), patients with serious diseases will have access to drugs still undergoing clinical trials and that have not yet been approved by the KFDA. The government hopes to maximize treatment options for patients suffering from AIDS or the last-stages of cancer.

This process would require manufacturers to register the production specifics. In addition, the government would review the safety and potency of new drugs before product registration.

In addition, the government also passed a bill to reduce administrative barriers for treatment for patients with diseases caused by defoliants.