New Medical Device Management Center in China
China’s State Food & Drug Administration (SFDA) officially inaugurated its Management Center for Medical Device Standards March 30. The inauguration was held in the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP). SFDA’s Deputy Commissioner, Zhang Jingli, attended the opening ceremony and delivered speeches.
The main functions of this new Center include committing to develop related standards for medical devices, organizing relevant medical device standardization technical committees to promote and carry out standards in manufacturing, and develop standards for instruments. Other plans include possible improvements to medical device naming, classification, and coding.
Zhang noted the significance of this development, where this Center would standardize medical equipment development, production, management, and supervision to ensure compliance. SFDA will greatly encourage the improvement and innovation of medical device standards, establish and improve the standards system, promote the development of China’s medical device industry and provide more support to the supervision of medical devices to ensure the safety and effectiveness of medical devices for the public.
Thus far, China has issued 180 national standards and 727 industrial standards for medical devices. They have also established 22 medical device standardization technical committees to offer technical support.
Crackdown on drug kickbacks in Vietnam
In Vietnam, it was recently discovered that a major U.S. drug company was involved with Ho Chi Minh City (HCMC) doctors promoting two types of drugs in exchange for commission. These doctors allegedly accepted kickbacks to prescribe drugs made by Schering-Plough, which merged with Merck & Co. Inc. in 2009. In light of this news, Prime Minister Nguyen Tan Dung has ordered the Ministry of Health to impose penalties on any pharmaceutical companies and doctors who engage in kickbacks.
The Drug Administration of Vietnam (DAV) set up a team in March 2010 to investigate prices at drug distributors and manufacturers in HCMC. DAV will submit their findings to the Ministry of Health by April 15. Leaders of HCMC’s medical university and its hospital also held a press conference on March 29, 2010 to discuss the controversy and announce its course of action in regards to its staff. The hospital has suspended the doctors temporarily. In addition, they will block contact between physicians and pharmaceutical representatives on hospital premises.
Commissions can be widespread, where doctors set up private practices to supplement their low state salaries. In the industry, many local pharmaceutical representatives have discussed the common practice of offering gifts, kickbacks, and meeting outside of hospitals.
Medical product harmonization meeting in Japan
Japan recently hosted the APEC Life Sciences Innovation Forum (LSIF) Regulatory Harmonization Steering Committee (RHSC) meeting March 2-4. RHSC was established in 2008 to promote a strategic and coordinated approach to regulatory harmonization and capacity building efforts within the APEC region. A harmonized global regulatory system would eliminate redundant reviews and requirements, improving trade and increasing safety for consumers.
Global Harmonization Task Force (GHTF) training has helped encourage adopting GHTF guidance documents. For example, ASEAN (Association of South East Asian Nations) will most likely continue using these documents in the next three to ten years. Countries such as Malaysia, Singapore, Thailand, etc. have revised or are in the process of revising their medical device regulatory schemes based on GHTF principles.
Future APEC/GHTF trainings are planned, including an APEC funding delegation visit to the US and Canada in August 2010. There are also discussions of a possible future APEC Regulatory Harmonization Project with Asia.
The APEC LSIF also has an anti-counterfeit medical products initiative. The hope is to promote the APEC Anti-counterfeit Medical Products Action Plan, based on the seminars presented by US DOC and USFDA in 2008. In addition to proposing detection technologies, the US is planning to work closely with the World Health Organization International Medical Products Anti-Counterfeiting Task Force (WHO IMPACT) in implementing future APEC anti-counterfeit programs.
Participants in the meeting included health authority representatives from Canada, China, Taiwan, Japan, South Korea, Thailand and the US and from pharmaceutical/medical device industry representatives.
Increasing regulations on drugs in Hong Kong
After a rash of incidents leading to patient deaths in Hong Kong hospitals in 2009, a review committee has developed 75 recommendation points aimed at improving the safety of prescription drugs. Under the Food and Health Bureau (FHB) and Department of Health (DH)’s supervision, a comprehensive review was published in 2010.
One of the first recommendations includes upgrading the current Hong Kong GMP standards to a higher international standard. Currently, Hong Kong is adopting the GMP standard promulgated by WHO in 1995. The Review Committee recommends that the GMP standard be first upgraded to the standard promulgated by WHO in 2007. After approximately two years, the Review Committee suggests upgrading to an even higher standard devised by the Pharmaceutical Inspection Cooperation Scheme (PIC/S).
Other recommendations include microbiological monitoring for non-sterile drugs during the manufacturing process, tightening up the qualifications of the Authorization Person (AP) by increasing the required number of years of industrial experience, requiring all companies involved in repackaging to have a manufacturing license, requiring bioavailability and bioequivalence studies for drug registration, etc. The Review Committee also recommended introducing a Code of Practice for wholesalers, importers, and exporters, and to strengthen the tracking system for drugs imported for re-export purpose.
The government is currently following up on these recommendations to determine actions plans and implementation strategies. FHB will oversee the policy issues, and together with the DH, will take forward the necessary legislative amendments, address the resource needs and requirements involved.
Ames Gross is president and founder of Pacific Bridge Medical, recognized nationally and internationally as a leader in the Asian medical markets. He founded PBM in 1988 and has helped hundreds of medical companies with business development and regulatory issues in Asia. Ames can be reached at email@example.com