Chang-Hong Whitney02.27.07
The SFDA suffered its largest public humiliation in 2005 and 2006 with arrests of three top officials—the head of the SFDA, the director of the medical equipment registration department and the director of the drug registration department. All were accused and convicted of accepting bribes from companies. Before and after these arrests, other officials in provincial FDA offices were found guilty of accepting money or other items with large cash values. The entire system went through a period of self-evaluation, correction and replacement of key positions. As result, activities at SFDA slowed to a halt with thousands of registration applications delayed for approvals.
After two years of scandals and indecisions, the SFDA seems to have found its confidence and directions for 2007. This year, the SFDA will focus more attention on market surveillance programs and on assessment of existing medical device manufacturers with the hope of eliminating unqualified producers and inferior products. There are a few signs worth noticing:
1. The SDFA has initiated a trial program to inspect quality systems of Class III sterile and implantable products. This program selected 10 product categories and manufacturers in Shanghai, Beijing, Tianjin, Zhejiang Province, Guangdong Province, Sichuan and Shanxi provinces. The program’s kickoff meeting was held in December, and inspections either are in progress or will be completed by April.
This program is a follow-up of a July 2006 inspection that the SFDA performed on Chinese manufacturers of cardiac stents. Of 17 companies inspected, six were ordered to stop manufacturing immediately; six were required to correct issues within a set period of time; and only five were considered to have adequate quality systems and procedures in place. Besides quality system inspections, the China Clinical Inspection Center has been conducting regular checkups on products on the market and publishes its testing reports.
2. The SFDA is weighing whether to station inspectors at some pharmaceutical companies in the future, with the goal of better monitoring their operations to the established standards.
3. The SFDA has required medical device manufacturers to comply with ISO 13495. There have been talks about other good manufacturing practices guidelines as well. This move is facing resistance as manufacturers complain of increased costs in their regulatory affairs. It is worth noting that good manufacturing practices have been implemented widely in China’s pharmaceutical industry for the past few years.
4. The SFDA drafted a regulation on product recall in December and is asking for public comments on the draft document.
Besides these activities, the SFDA is working hard in other areas. For example, the agency is working on implementing both national and industry standards pertaining to technical and safety product performance at the time of product registration. Close scrutiny on registration documentations and testing results have been observed by testing centers and by consulting firms such as my own.
The SFDA is not alone in its efforts to improve the healthcare system. Other Chinese agencies are joining the efforts on market and product controls. The Ministry of Information Industry implemented its first environmental protection law—China’s regulation on hazardous substances, widely known as RoHS—on March 1 this year. And the China Administration of Quality Supervision and Quarantine, which controls the Chinese customs and CCC certification labs, has set food and medical devices as its focus areas for 2007 to improve the testing and incoming inspections.
Without doubt, 2007 will be another challenging year for medical companies. Besides the anticipated regulations, the entire healthcare market also will be modified based on MOH policies and the initiatives for better healthcare for the masses. High costs in product development and market approvals, as well as the shrinking market size, will drive some weak players out of the market, while the stronger ones will need to reinvent themselves and find a niche to weather through the market downturns.
The positive side of this adjustment, however, is a better managed, better regulated and ethical marketplace with players that follow best business practices, focus attention to quality and customer services as well as seek to expand their international markets. In turn, it is hoped that these improvements will establish a positive reputation for Chinese medical products and, therefore, sustain the Chinese medical device industry. If those of us who are still in the game can keep our faith, there will be a better future to which we can look forward. I will be more than happy to report the positive news in the months to come. Stay tuned.