China Releases New Regs To Step Up Quality Control For Essential Drugs; Second Part Of EDL Expected In November
This article was originally published in PharmAsia News
Executive Summary
SHANGHAI - In the latest effort to strengthen drug safety measures in China, China's State FDA issued Sept. 24 a new quality control regulation for drugs listed on the Essential Drug List. The regulation asks local FDAs to conduct at least two inspections every year of all manufacturing sites for drugs listed
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SHANGHAI - In the latest effort to strengthen drug safety measures in China, China's State FDA issued Sept. 24 a new quality control regulation for drugs listed on the Essential Drug List. The regulation asks local FDAs to conduct at least two inspections every year of all manufacturing sites for drugs listed. As a key project of China's $124 billion healthcare reform, the essential drug system was implemented Sept. 21 in 30 percent of the government-run low-tier hospitals and clinics. Issued Aug. 18, the first part of the EDL lists 307 drugs for community health organizations (Also see "China Releases First Part Of Essential Drug List For Community Health Clinics And Rural Hospitals" - Scrip, 19 Aug, 2009.). "The second part of the EDL for large and mid-sized hospitals is expected to be released in November together with the reform plan for public hospitals," Xie Xiaoyu, the director of the Essential Drug System Division under MOH's Drug Policy, said during a forum on government relations and marketing strategies in Beijing Sept. 25. Xie noted that several new regulations will be released by the end of October, which will include a new regulation on distribution management for the EDL and another regulation on usage of the essential drugs. The clinical guidelines for essential drugs and the national formulary will be released in November, added Xie. The draft for the national formulary, which will cover 194 common diseases in China, was published on MOH's website; the public comment period for the draft closed Sept. 30. The formulary lists many drugs that are on the EDL and recommends these drugs as first-line treatments, which is one way the government plans to promote its EDL, according to Bin Li, executive director of the research department at Morgan Stanley (Also see "China Releases Draft Of National Formulary To Address Over-Prescribing, Promote EDL" - Scrip, 22 Sep, 2009.). Stricter Oversight To Ensure Quality Control For Essential Drugs Beyond the two annual inspections of manufacturing sites, SFDA will also increase the frequency of sample testing for drugs on the EDL, which local FDAs will test at least once a year, according to the new regulation. The products on the list will be covered by an electronic drug monitoring system, says SFDA, which will also better compliance and quality data. Under the regulation, manufacturers of essential drugs will be asked to institute a "quality attorney system" to improve manufacturers' quality systems. First piloted in Guangdong province in 2007, the quality attorney system assigns responsibility for drug manufacturing quality to a designated company official (Also see "Chinese Province Implements Pilot Quality System To Strengthen Drug Safety" - Scrip, 30 Jul, 2007.). The government will further encourage mergers and acquisitions among drug distributors for essential drugs in order to consolidate smaller players in the industry. -Dai Jialing ([email protected]) |