HONG KONG TO INTRODUCE CONFORMITY ASSESSMENT FRAMEWORK FOR MEDICAL DEVICES
The Hong Kong Medical Device Control Office (MDCO) is planning to introduce a conformity assessment (CA) framework as part of its its Medical Device Administrative Control System (MDACS). The framework is intended to improve the quality management of medical devices. The CA would demonstrate that a medical device is safe and performs as intended by the manufacturer. When implemented, it would be a necessary stage of being listed in the MDACS.

In the proposal, CA would be conducted by an independent Conformity Assessment Body (CAB). This body must be recognized by the government and based in Hong Kong. The manufacturer must draw up a set of documents to demonstrate its product’s safety and accurate performance, depending on the product’s risk classification. The CAB will not only conduct the assessment but also judge the conformity of products. Alternatively, medical devices which have already undergone CA in countries such as Australia, Canada, Japan, the US, or the EU will be able to receive certification on that basis without going through a CAB.

Listing in the MDACS is not currently compulsory, and is only done on a voluntary basis. However, one of its objectives is to familiarize manufacturers with its requirements for when it becomes a system of compulsory registration in the future. Currently, there is no comprehensive set of legislation to regulate the import or sale of medical devices in Hong Kong. The MDCO launched the MDACS program in November 2004.

The MDCO plans to hold briefing sessions on its proposals on August 10, 2006. The proposed documents to be introduced are available on the MDCO website (http://www.mdco.gov.hk).

JAPAN REGULATORS INCREASE USE OF “CONDITIONAL APPROVALS” ON DRUGS
Amid discontent over Japan’s delay-ridden drug approval process, its regulatory authorities are making greater use of an instrument known as “conditional approval.” According to the Pharmaceutical Affairs Law, the Ministry of Health, Labor and Welfare (MHLW) can require the market authorization holder to conduct more safety and efficacy studies after the initial marketing of the product. If the market authorization holder does not comply with the conditions, the MHLW can revoke or amend the approval. One drug with conditional approval was Remicade (infliximab), approved for rheumatoid arthritis in Japan in 2003. After approval, Tanabe Seiyaku was required to conduct a long-term study of Remicade’s safety and efficacy for all patients taking it. During that study, the number of hospitals that could prescribe Remicade was limited. The results were accepted by the MHLW in 2005.

On July 20th, 2006, Mikio Sasai, a researcher for the Japan Pharmaceutical Manufacturers’ Association (JPMA), presented an overview of the MHLW’s use of conditional approvals over the 141 new drug approvals issued from 2000 to 2005. According to his research, the proportion of conditional approvals increased from 30% in the 2000-2002 period to 50% in 2003-2005. Over the entire period, some subcategories of drugs had more conditional approvals, such as orphan drugs (100%) and drugs using foreign clinical trials (50%). He also found that the average development period for drugs with conditional approvals was 63.1 months, or 16 months less than drugs without conditional approvals. At the same time, drugs with conditional approvals appeared to have higher total development costs.

Sasai commented that regulators seemed to commonly use conditional approvals as a tool to help shorten the long gap between approval in the US or Europe and approval in Japan. Often, they used post-approval clinical studies to help confirm that efficacies were similar between Japanese and non-Japanese test populations. Requiring tests on native subjects has long been a cause of delays in the Japanese approval process. The use of conditional approvals is likely to increase in coming years.

CANCER IN CHINA
In recent years, cancer has become a more salient issue in China. Currently, 1.5 million Chinese die of cancer annually, more than any other disease, and this number is growing fast. Chinese make up one quarter of all cancer sufferers in the world. The country’s population is aging rapidly, and other lifestyle and environmental changes too are contributing heavily to cancer incidence. To deal with this growing disease, the cancer field will need much investment from both the public and private sectors in coming years.

Currently, most cancer treatment in China is still performed by state-run cancer hospitals. These hospitals are overfilled, and the use of bribes and personal connections is commonplace. In general, private hospitals in China tend to concentrate on primary care, not cancer specifically. At the same time, cancer treatment is unaffordable to many lower-income Chinese, with roughly 40% of its estimated 2.5 million annual new sufferers not seeking treatment. The new national health insurance system, which is designed to take contributions from workers, employers, and the government, may eventually increase the number who can obtain treatment.

The Chinese government is also turning its attention to cancer treatment. In one program, it is setting up nationwide breast cancer screening centers to screen over 1 million women over 4-6 years. It is also conducting an anti-smoking campaign. As over 350 million Chinese smoke, and air pollution levels are rising, there were 340,000 deaths from lung cancer in 2005. However, the government’s chief priority in medical funding remains the universal delivery of primary care, rather than cancer treatment.

This situation is creating a wide range of opportunities for foreign medical companies. Roche, for example, predicts its cancer drugs will lead its sales in China over the next five years. Radiological equipment remains relatively scarce outside of major cities. Sales of drugs and devices are just one area of growth in China’s cancer markets. The sheer numbers of cancer sufferers also mean that many subjects are available for pharmaceutical trials, including sufferers of rare forms of cancer. Clinical trials in China are growing very quickly. AstraZeneca recently announced an investment of $100 million on clinical research in China, mostly cancer-related. Other opportunities include an increase in private treatment centers and the training of local professionals in modern treatment methods.

SINGAPORE: MANUFACTURERS WORKING TO DEVELOP MEDICAL DEVICE SOURCING
As a number of Singapore-based companies move into medical device production, government agencies are identifying the sector as a key growth area. Products which local companies have moved into recently include airway devices, infusion pumps, and gas detection equipment. These companies are seeking to establish original equipment manufacturer (OEM) relationships with existing Western medical device firms.

Singapore has not typically been thought of as a likely site for medical device manufacturing, probably because of its high labor costs. However, Singapore’s trade promotion agency, International Enterprise Singapore (IES), believes they have advantages in quality control, intellectual property protection, and engineering talent. Some companies have sought to transfer expertise in other fields, such as electrical engineering and quality control, to help develop high-level medical device capabilities. The government estimates that 15 local companies have now received ISO 13485 certification. IES recommends that manufacturers try to break into the market for parts for large, complex, low-volume devices which are harder to produce in low-wage countries, such as X-ray machines and CT scanners. For simpler devices, where price competition is fierce, it suggests that they also take up engineering, design, and supply-chain functions, forging strategic and comprehensive partnerships.

To help encourage and facilitate sourcing relationships, IES has organized a number of trips between Europe and Singapore to bring together local and Western firms. Also, IES, the Economic Development Board, and the Standards, Productivity, and Innovation Board have created the Medtech Local Supplier Group, which facilitated a number of supply agreements last year.