SFDA Unveils Five-Year Plan To Raise Drug Supervision Standards
This article was originally published in PharmAsia News
Executive Summary
SHANGHAI - China's State FDA aims to raise drug quality and supervision standards over the next five years to reach international levels and to control risks associated with traditional Chinese medicines, according to Wu Zhen, deputy director of SFDA
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SHANGHAI - China's State FDA aims to raise drug quality and supervision standards over the next five years to reach international levels and to control risks associated with traditional Chinese medicines, according to Wu Zhen, deputy director of SFDA. Wu said during a national SFDA gathering on food and drug supervision on Jan. 14 that regulators would revise and upgrade pharmaceutical GMP guidelines this year. The SFDA will also issue GMP guidelines for medical devices in 2009. He also said the drug watchdog would undertake five primary missions in 2009, which were outlined as follows: 1. Improve the drug review process; 2. Raise drug quality standards; 3. Enhance monitoring on drug safety; 4. Strengthen monitoring of adverse drug reactions; and 5. Improve the drug approval system. SFDA will establish a system to rapidly remove drugs with serious safety risks from the market. Chinese drug regulators will step up post-market reevaluations of all drugs, especially high-risk pharmaceuticals and injectable products, Wu said. He also urged drug companies to submit ADR reports following any adverse event. Earlier this month, the SFDA unveiled a new fast track procedure for drug approvals, and will issue regulations on drug technology transfers (Also see "China Issues Fast-Track Registration Procedure For Drugs To Balance Innovation And Risk: SFDA Press Conference" - Scrip, 12 Jan, 2009.). SFDA also intends to bring about regulatory changes to better promote drug innovations and to reduce the copying of drugs, the deputy director said. Shao Mingli, director of SFDA, said that the organization uncovered 297,500 cases of drugs and medical devices that violated its regulations during inspections in 2008. Those drugs and devices were collectively valued at RMB 595 million ($86.9 million). New GMP Guidelines For Medical Devices China will issue new GMP guidelines on medical devices this year, along with provisions on the recall of devices, said Zhang Jingli, deputy director of SFDA. Zhang, who is in charge of medical device supervision, said during the Jan. 14 meeting that the SFDA will also revise its provisions on medical device registration in 2009, but he did not provide any details. SFDA started drafting new medical device GMP guidelines in 2006, and published draft procedures for the recall of devices in March of 2008. Yang Chen, who leads the China life sciences team at the Beijing office of international law firm Sidley Austin, recently outlined regulatory changes in the works on medical devices, along with new laws that will impose a higher level of legal responsibility on foreign device makers and their Chinese partners (Also see "China’s 2009 Regulatory Changes Will Affect Makers of Drugs, APIs and Devices" - Scrip, 5 Jan, 2009.). SFDA has drafted new regulations on the supervision of medical devices, and has sent the proposed measures for review by China's State Council, or premier's office, Zhang said. Meanwhile, the SFDA is creating a new committee this year to set out quality and safety standards for medical devices, according to Zhang. - Dai Jialing ([email protected]) |