Asia Medical eNewsletter
January 2010
SFDA Issues Good Manufacturing Practice (GMP) for Medical Devices
China's State Food and Drug Administration (SFDA) issued various medical device GMP regulations in December 2009. These regulations include detailed GMP rules for sterile and implantable medical devices and GMP inspection standards for sterile and implantable medical devices. All of these regulations have been marked as interim and could be subject to change.
SFDA has also issued notices on standardizing the production quality management systems and supervision and inspection of sterile/implantable medical devices.
For non-sterile/implantable medical devices, SFDA has formulated Good Manufacturing Practice for Medical Devices (interim) and Requirements for Medical Device GMP Inspection (interim). These regulations will standardize quality management systems, intensify supervision on manufacturing, and strengthen the management of medical device GMP inspection.
The Good Manufacturing Practice for Medical Devices (interim) is made of 13 chapters, 69 articles and will take effect as of January 1, 2011. The 13 chapters include management responsibilities, files and record requirements, design and development, manufacturing management, inspections, sales and services, adverse events, etc.
China-Japan-Korea Working Group (WG) on Drug Clinical Trials
On December 17, 2009, China, Japan, and Korea participated in the second WG meeting on drug clinical trials. This meeting included China's SFDA, Korea's Food and Drug Administration (KFDA), and Japan's Ministry of Health Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA). SFDA's Director-General of the Drug Registration Mr. Zhang Wei, KFDA's Director-General of the Drug Evaluation Department Dr. Sun-Hee Lee, MHLW's International Planning Director Mr. Shinobu Uzu, and PMDA's Chief Executive Dr. Tatsuya Kondo were the main representatives from each country.
The representatives agreed on the Terms of Reference of the WG. The Terms outline WG's objectives, prospective projects, procedures, participants, and other rules. The two projects the WG works on are (1) research on ethnic factors in clinical data from the three countries, and (2) information exchange on drug clinical trials.
Project 1 is primarily focused on pharmacokinetic data from the three countries. The hope is that this analysis will determine the possibility of clinical data sharing within East Asia. MHLW/PMDA will be the coordinator of this project and will propose a detailed work plan to WG.
The second project will involve the three health authorities exchanging information on drug clinical trials both on a regular and ad-hoc basis. KFDA will coordinate this project and will provide a detailed work plan.
KFDA announced its plan to host the next WG meetings next year.
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Hong Kong Starts Class D IVD Medical Device Listing in December 2009
Starting from December 1, 2009, Hong Kong has now set up the process to list Class D In Vitro Diagnostic (IVD) Medical Devices under the Medical Device Administration Control System.
IVD medical devices are classified in Hong Kong similar to the guidelines outlined by the Global Harmonization Task Force, GHTF. There are four classes according to risk level (Class A to D) where Class A is the lowest risk and Class D the highest. Examples of Class D IVD medical devices include Hepatitis B and HIV tests.
To list a Class D IVD medical device, applicants will submit Application Form MD-IVD and the Essential Principles Conformity Checklist. Both forms are available on the Medical Device Control Office's website athttp://www.mdco.gov.hk. Applicants will need to fill in information about the device, details on the Local Responsible Person in Hong Kong, marketing approvals overseas, quality management system information, etc.
The detailed guidelines are listed under GN-06: Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices and TR-006: Principles of In Vitro Diagnostic (IVD) Medical Devices Classification. Listing of other classes of IVD medical devices will be launched at a later stage.
India to Ramp Up Drug Pharmacovigilance Program
The Drug Controller General of India (DCGI) plans to revive the pharmacovigilance program initially launched in 2004, after holding a workshop on December 29 and 30, 2009. About 20 centers were open to record adverse drug reactions but the program has been neglected for the past five years.
Now, the national pharmacovigilance program will be headquartered at the All India Institute for Medical Sciences (AIIMS) in Delhi. The DCGI office (Central Drugs Standard Control Organization, CDSCO) will provide administrative and financial support to AIIMS. The four CDSCO zonal offices located in Chennai, Ghaziabad, Kolkata, and Mumbai will act as branch offices of the program.
40 of 294 medical colleges in the country will be involved in the first phase of this program. Eventually, the hope is to have all 294 medical colleges participate in pharmacovigilance. In addition, there are plans to have pharmacovigilance centers in hospitals to keep track of adverse drug reactions. The AIIMS center would then collect all the data from the medical colleges, hospitals, and the public to make sure appropriate, corrective action is taken.
The pharmacovigilance program would work to ensure that fake drugs were not circulated in the market, and outdated and banned drugs are not sold. In addition, certain controversial drugs would also be under close watch. India's Drugs Technical Advisory Board recommended such drugs as nasal decongestant phenlypropanolamine, fertility drug letrozole, non-steroidal anti-inflammatory nimesulide, and antibiotic gatifloxacine to be on this list. Some of these drugs have been sold in the India market for years but there is no record of adverse drug reactions.
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