Since China’s State Food and Drug Administration (SFDA) revised its GMPs last year (they became effective Mar. 1, 2011), the agency has been making other improvements to enhance the quality of its pharmaceutical manufacturing industry. Many improvements are tied to the 2015 deadline SFDA has placed on existing domestic drug manufacturers to implement the revised guidelines. Newly created companies are expected to meet the new GMPs from the start.
Recent announcements on the SFDA website note ongoing changes and requirements. For example, SFDA is working to strengthen the way it manages drug GMP inspections by standardizing its inspection and certification procedures and requirements. Along these lines, the agency revised its requirements for appointing and evaluating drug GMP inspectors.
In July, SFDA issued specific requirements regarding contract-manufacturing assignments from foreign pharmaceutical companies. The agency says it will monitor the acceptance of these contracts and regulate them more strictly.
Anticounterfeiting measures also seem to be high on China’s list. To ensure drug safety for the public, SFDA says it is cracking down on Internet and mail-order sales of counterfeit drugs. “Since the establishment of SFDA’s leading group of the special operation against IPR [intellectual property rights] infringement and counterfeiting in November 2010, the SFDA has organized the nationwide food and drug regulatory departments involved in this special operation and has made stage achievements with the support and cooperation from the departments of public security, departments of industry and information technology and other relevant departments,” says a release about the agency’s efforts. Previously, the agency had increased the agency’s technical capacity as well as routine inspections and sampling.
When China released its new GMPs in February of this year, an SFDA press release noted that the revised guidelines borrow from “advanced international experiences” and that they incorporate “the concepts of quality risk management and whole process control of drug manufacturing, [thereby attaching] more importance to the scientific nature, instruction function and maneuverability, so as to [be] consistent with the [World Health Organization] WHO GMP.” It seems that the agency is working to meet these goals.
Of note, INTERPHEX China is taking place Nov. 9-11, 2011, in Nanjing, and will feature a unique program put together by Pharmaceutical Technology on buying and validating GMP-compliant equipment.
The Chinese government’s mandate to improve the quality of the country’s pharmaceutical industry includes manufacturing supplies, from raw materials to equipment. The program is aimed at helping pharmaceutical manufacturers understand the new quality requirements for equipment and offer some information on how to evaluate equipment to determine whether it’s compliant. This program will bring together regulators, equipment vendors, and procurement officers, all offering their perspectives and advice on purchasing and validating quality equipment.
“China’s State Food and Drug Administration Discusses Drug Applications” Pharm. Technol. 34 (11), 66–70 (2010).