JAPAN PLANS TO CHANGE RULES ON CLINICAL TRIALS
The Japanese government has announced that it plans to change the clinical trial requirements for new drug approval in Japan. In a March 2006 interview, Akira Miyajima, the Chief Executive of the Pharmaceutical and Medical Devices Agency (PMDA), stated that the PMDA is considering issuing new guidelines that would reduce the amount of clinical data on ethnic Japanese required before a new drug may be considered for approval. If implemented, these new rules could expedite the approval of new drugs in Japan, which is known to be a very lengthy process.

Currently, any new drug requesting approval by the PMDA must first undergo clinical trials, in which a certain minimum proportion of subjects must be ethnic Japanese. This requirement is in place because of concern for the potential variance in a drug’s effect depending on the subject’s ethnicity. This is one of the reasons that the Japanese government is wary of accepting significant foreign clinical data for approval of a new drug.

Mr. Miyajima has suggested that the PMDA may consider accepting data on other Asian subjects in lieu of requiring data on people of Japanese descent only. In addition, the relaxed clinical data requirements could be supplemented with stronger post-market surveillance to monitor any side effects of new drugs. Mr. Miyajima stated that the PMDA hoped to issue the new guidelines within the next year.

CHINA’S STATE FOOD AND DRUG ADMINISTRATION LAUNCHES CRACKDOWN ON COMMERCIAL BRIBERY
At a national conference in April 2006, the SFDA announced the launch of a new anti-corruption campaign targeted at drug and device manufacturers and distributors in order to crack down on commercial bribery. The main objective of the campaign is to provide education on the importance of complying with the law and honest business activities. In addition, the SFDA will begin blacklisting any drug or medical device companies that engage in bribery in their business activities. Blacklisted companies that do not take immediate steps to rectify the situation will be penalized, and could ultimately lose their production license. The SFDA has also set up a hot line for whistleblowers to report any complaints or suspicious activity.

Corruption in the medical sector in China is rampant, as evidenced by the arrests of several SFDA officials on charges of bribery earlier this year. SFDA officials responsible for approving new drugs, including the director of the department of Drug Registration, have been accused of accepting bribes from drug companies wanting to push through approval of their drugs. Drug companies that sell drugs whose prices have been cut by the National Development and Reform Commission’s have also been known to register the same drug under a different name. In doing so, they are able to get around the price cuts, marketing the so-called “new” drug at a higher price. Corruption throughout the drug industry and the government resulted in the approval of some thousands of new drugs in 2004, compared to about 150 new drugs in the U.S. Drug companies also bribe doctors, hospital administrators, and health officials to ensure that their drugs are used or prescribed. Hospitals have the incentive to cooperate because they generate most of their income from drug sales.

The Chinese Minister of Health will lead the team responsible for overseeing the crackdown on commercial bribery in the medical sector. In addition to this new campaign, the SFDA has gotten tough on corruption in the past year, withdrawing over 60 licenses and destroying over 450 illegal drug factories.

INDIAN GOVERNMENT EXTENDS DEVICE REGISTRATION DEADLINE
On April 28, 2006, the Indian government extended the last date for device registration from April 30, 2006 to June 30, 2006. This extension gives medical device manufacturers, who have devices that now require registration in India, about 2 more months to submit their dossiers.

As mentioned in last month’s newsletter, there are a number of items that need to be provided in the dossier, which are outlined in Form 40 and Schedules I and II. Providing only partial data in the application (with the rest to be submitted later) will not work, according to our local sources in India. One of the risks of submitting partial data is that the manufacturer would have paid the application fees of $1,500 per factory and $1,000 per product, and then the application may be rejected. The manufacturer might need to start the process all over again (and perhaps have to pay the fees again).

Despite this extension until June 30, the consequences of a late application are not spelled out yet. In addition, no one can commit that a late application will or will not be accepted.

CHINA CREATES ADMINISTRATIVE SERVICE CENTER TO OVERSEE LICENSING FOR NEW MEDICAL DEVICES AND DRUGS
In April 2006, the Chinese government opened a new Administrative Service Center to handle license applications for new medical devices and drugs in China more efficiently. This center, which is part of the State Food and Drug Administration (SFDA), will undertake administrative functions such as administrative acceptance, certificate making and delivery, and announcements. The center will also screen the registration applicants and their respective products to ensure that they are qualified to apply for product licenses.

Until now, the administrative acceptance, technical evaluation, and approval processes were “bundled.” The new Administrative Service Center separates the administrative process from the evaluation and approval processes, and will only perform “format” checks instead of substantial content checks. The new center will serve as a one-stop shop for these administrative services and will be held accountable for processing applications within certain time limits. The stated goal of the new center is to provide open, transparent, efficient, and convenient services to the applicants. It is also hoped that the increased transparency and accountability promoted by the new service center will help to minimize the opportunity for corruption in the SFDA.