MEDICAL DEVICE COMPANIES BLACKLISTED IN CHINA
The State Food and Drug Administration (SFDA) of China has blacklisted 13 companies manufacturing unapproved medical devices. SFDA ran a spot check of 17 provinces, including Beijing, Shanghai, Guangdong, and others.

The unapproved medical devices included single-use transfusion machines, metal bone and joint implants, and endoscopic devices. For five companies, 80 percent of photonic cosmetic machines were unqualified, while over 40 percent of high frequency electric knives in general were unapproved. Over 10 percent of the medical devices checked were unqualified.

The companies will be subject to fines or complete shut down if they do not change their manufacturing methods and improve their quality control.

Starting in September 2007, China has launched a six-month project to inspect medical device licenses and make sure that all information submitted during the registration process is accurate. The SFDA will blacklist and publicly expose any companies supplying false information.

SFDA is also planning to improve its recall system for medical devices. SFDA has already implemented a recall system for drugs.

INCREASED PENALTIES FOR COUNTERFEIT DRUGS IN THAILAND
Thailand’s Food and Drug Administration (FDA) is planning to increase fines on importers, sellers, and manufacturers of fake drugs. Currently, the FDA is proposing to amend Drug Act of B.E. 2510 where manufacturers can be fined up to 5 million baht (about US$168,000) while importers and sellers can be fined up to 2 million baht (about US$67,000).

Based on the current Drug Act of B.E. 2510, fake drug manufacturers can be imprisoned for life with a maximum fine of 50,000 baht (about US$1,681). Fake drug importers and sellers can be jailed for up to 20 years with a maximum fine of 10,000 baht (about US$336). The new amendment would not change the jail terms, but would increase the maximum fines as outlined above.

According to Thailand’s FDA, almost $30 million worth of counterfeit drugs are sold in the country each year. The most common fake drugs are those indicated for treating AIDS, bird flu, malaria, tuberculosis, anti-obesity, and erectile dysfunction. However, fake drugs account for a very small percentage of the market – drug consumption in Thailand is about $3 billion with $1.4 billion worth of imported drugs.

Thailand’s focus on counterfeit drugs follows its participation in a regional ASEAN-China conference in November 2007. The conference, with the aid of Interpol, the World Health Organization and other groups, aimed at increasing enforcement of WHO’s IMPACT program.

IMPACT, standing for International Medical Product Anti-Counterfeiting Taskforce, started in 2006. It will have its first global forum in February 2008 in Singapore. IMPACT is working on legislation and enforcement against counterfeit drugs globally by drafting up guidelines and establishing five working groups.

WHO estimates that counterfeit drugs make up more than 25 percent of the medical market in developing countries.

SINGAPORE ISSUES DRAFT GUIDANCE DOCUMENTS FOR FIRST PHASE OF HEALTH PRODUCTS ACT
The Health Sciences Authority (HSA) of Singapore has recently issued various Guidance Document drafts on their website. As described in Volume 7, Issue No. 10, Singapore passed its Health Products Act in February 2007 to regulate all medical products, including medical devices.

The first phase primarily deals with implementing certain duties and obligations on medical device dealers, as well as regulating advertisements and promotions. In HSA's proposed documents, advertisements should not carry testimonials or recommendations by health professionals. Advertisements should also be accurate, truthful, and supported by scientific data when necessary.

Registrants, manufacturers, importers, and wholesalers (including exporters) would all be required to maintain distribution records of each device product. As of now, HSA has proposed basic information requirements, such as batch numbers, date shipped, and quantity of devices shipped. HSA has also proposed definitions for reportable adverse events and timelines. All persons who register, manufacture, import, and supply device products in Singapore would be required to report adverse events involving medical devices placed on the market.

HSA also drafted Guidance Notes on preparing a Site Master File. The proposed requirements include general information on the site, personnel, layout and description of the facilities, inventory control, documentation, handling recalls, etc.

HSA issued these draft documents at the end of October 2007 and asked for comments by November 2007. As of now, there have been no revised, formal updates posted by the HSA on their website.

JAPAN TO INCREASE DRUG PRICE RATES FOR INNOVATIVE PRODUCTS
Chuikyo, Japan’s Central Social Insurance Medical Council, plans to increase the National Health Insurance drug price premium rates for certain drugs. These products include drugs that are innovative, drugs that demonstrate increased usefulness, pediatric medicines, orphan drugs, and kits.

The premium rate for innovativeness will increase from 50-100% to 70-120%. Examples of innovative products include those demonstrating increased efficacy or safety compared to similar products, or those containing a clinically useful new mechanism of action.

The premium rate for usefulness group (I) will increase from 25-40% to 35-60% while the premium rate for usefulness group (II) will increase from 5-20% to 5-30%. The difference between the two groups is that drugs under usefulness (I) will have to satisfy two of three requirements while drugs under usefulness (II) only have to satisfy one or more requirements. These requirements are very similar to those outlined for innovative products.

The premium rate for pediatric medicines will increase from 3-10% to 5-20%. Chuikyo also plans to revise the requirements for drugs listed under this category. The first requirement stating that the indications and efficacy are specifically for children will not change. However, the second requirement will be revised. Drug products must also have comparable products that did not receive any pediatric medicine reimbursement in the past. Drugs must fulfill both of these requirements to be categorized into this group.

The category for orphan drugs also has two subgroups. The premium rate for orphan drugs (I) will increase from 10% to 10-20% while the premium rate for orphan drugs (II) will increase from 3% to 5%. The main difference between the two groups is that drugs under orphan drug (I) must satisfy Article 77-2 of the Japan Pharmaceutical Affairs Law, while drugs under orphan drug (II) must satisfy a drug efficacy classification listed in the Japan Standard Commodity Classification.

The premium rate for kits will increase from 3% to 5%. Products under this category should reduce the chance of infection, reduce risk of mistakes during drug preparation, increase ease of use or increase quality of treatment when administered compared to similar products.