Some of the changes included reimbursement price increases to support additional safety checks of medical devices. For example, the MHLW will have clinical engineers involved in evaluating the following medical devices:

• Heart-lung Machines
• Blood Circulation Machines
• Artificial Respirators
• Blood Purifiers
• Defibrillators
• Closed Incubators

To support this additional service, the MHLW proposes increasing the reimbursement prices for these medical devices by 50 points.

In addition, the MHLW has also picked 42 out of 681 proposed new medical device categories to prioritize for reimbursement. Examples of these medical devices include stents for the carotid artery, medical devices placed in the C2 reimbursement category (a product with a new function and a new technology), and vessel sealing systems.

The MHLW has also proposed increased reimbursement for medical imaging equipment such as CT scanners, MRIs, and X-rays.

Medical device manufacturers have the opportunity to comment on these draft reimbursement prices before the MHLW finalizes these changes.

TAIWAN'S PLANS TO ADOPT INTERNATIONAL GUIDELINES FOR DRUG MANUFACTURERS
Taiwan’s Department of Health (DOH) has mandated that local drug manufacturers comply with the “Guideline for International Standard Site Inspection,” based on the Pharmaceutical Inspection Cooperation Theme (PIC/S). As of now, the DOH has sent requests to over 160 local drug manufacturers to comply with the new requirement.

To comply with PIC/S, manufacturers will need to produce certain drugs in dedicated facilities to avoid cross-contamination. These drugs include antibiotics, hormones, and anti-cancer drugs. Local manufacturers must comply with these requirements by 2009. Those companies who fail to do so may not get their licenses renewed by the DOH.

Currently for drug registration in Taiwan, applicants must submit a detailed Plant Master File before submitting the actual dossier. However, if Taiwan becomes an official member of PIC/S, the DOH will allow a Site Master File plus a PIC/S inspection report to fulfill this requirement. As of now, Taiwan has been unsuccessful in becoming a signatory to PIC/S.

ASIAN HARMONIZATION WORKING PARTY ISSUES FINAL DOCUMENTS ON SAFETY ALERT DISSEMINATION SYSTEM
The Asian Harmonization Working Party (AHWP) has finalized two documents on the Safety Alert Dissemination System (SADS) on January 23, 2008. The main goals of SADS are the following:

• To define a structure for disseminating medical device safety alerts among AHWP members;
• To define roles and responsibilities of regulatory authorities in receiving and disseminating safety alerts; and
• To define roles and responsibilities of manufacturers or their representatives in case of safety alerts.

To avoid an influx of information, AHWP has stated that only events resulting in imminent risk of death, serious injury, or serious illness should be reported.

Medical device manufacturers or their representatives would be responsible for filling out a SADS Form provided on the AHWP website. This form should be completed in English and submitted to the local regulatory authority. The local regulatory authority would then be responsible for disseminating this safety alert to other regulatory authorities via an e-mail system.

Manufacturers/representatives would also be responsible for the following under this SADS:

• Cooperating with the regulatory authority to conduct investigations on adverse events, performing remedial actions and disseminating safety information;
• Developing and implementing a procedure for communicating with the regulatory authorities on adverse events and safety information;
• Maintaining distribution records of products in all AHWP member economies; and
• Developing an efficient communication channel among all offices in the different AHWP member economies to ensure concerted remedial actions together, if appropriate.

In addition, AHWP is also conducting a survey on the post-market surveillance and vigilance system for AHWP Member Economies. AHWP plans to develop harmonized post-market surveillance and vigilance systems.

THAILAND TO HOST MEETING ON HARMONIZING DRUG CLINICAL TRIALS
As a member economy of the Asian-Pacific Economic Cooperation (APEC), Thailand will be hosting a workshop as part of APEC’s “Capacity Building for Drug Regulatory Agencies on Clinical Trial and Good Clinical Practice” on March 17-21, 2008.

Thailand proposed this project to strengthen drug regulatory authorities’ capacity to handle new therapeutic life sciences innovations and to promote harmonization of Good Clinical Practices. The workshop includes discussions on the clinical trial environment in respective countries, drug development, and clinical trial assessments.

Thailand plans to hold another workshop in August to review drug development in clinical trials. Thailand has also proposed two additional workshops on GCP inspection to ensure that drug regulatory authorities in each APEC member economy can appropriate assess compliance with GCP.

MEDICAL DEVICE EXPERTS TO HELP CHINA'S STATE FOOD AND DRUG ADMINISTRATION
China’s State Food and Drug Administration (SFDA) has decided to select medical device experts to enforce its “Regulations for Supervision and Administration of Medical Devices” and “Provisions for Medical Device Registration.” These experts will help standardize the technical examination of medical devices and ensure fair and efficient evaluation procedures. These experts will be available to the SFDA for medical device evaluation.

The SFDA issued draft revisions to these regulations in September 2007. Major changes included a new system on medical device recalls, increased checks during product registration, and standardizing manufacturing processes.