Last November, the State Food and Drug Administration launched a pilot evaluation of drug safety responsibility system work.digital blood pressure monitor Schedule according to the pilot, the first half of this year, the pilot provinces (autonomous regions and municipalities) should complete and implement the development program, 10 pilot concluded before the end of the experience, and for 2012, organized and implemented in a wider context.
From the eight pilot cities and five pilot cities to promote the work of independent point of view, although the pilot start-up time is not long, but the pilot areas of related work has been underway to advance.
Safety responsibility system evaluation is one of the key elements to strengthen the corporate self-examination. digital thermometer manufacturer Jinhua, Zhejiang Province, the only drug safety is the responsibility system evaluation of the pilot cities, the city Food and Drug Administration last month issued the first "drug quality and safety of medical device risk management (tentative)"digital thermometer (hereinafter referred to as the "Rules"), and strengthen risk management and control link.
Focus on troubleshooting the source
Currently, supervision is still facing more serious challenges. In 2010, Jinhua year investigation of drugs and medical devices 526 illegal cases, major cases of 19, seven transferred to the judiciary, banned the use of non-drug dens posing as a drug sales, the Internet without a license and selling dens 1 .
It is understood that the "measures" After extensive research, adhere to prevention is a matter of control and after sound principles, covering the potential impact of Medical Device manufacturing, operation and use of quality and safety aspects for the implementation of drug safety responsibility system, the establishment of an effective carrier .
"Measures" the eight kinds of business units as a risk object, that the credit rating of "basic and trustworthy" rating (inclusive), and the supervision and inspection last year found serious flaws in the project, the new start-up, electronic online monitoring process to identify critical staff positions do not post more than 3 times the enterprises. Medical Device as a risk to nine kinds of species, varieties of essential medicines list, like high-risk injection varieties, special medicines and drugs with a special compound, to be stored refrigerated drugs, drug quality announcement substandard medicines, medical devices based on "National monitor directory "contains sterile, implant, life support, free trial varieties, imported medical equipment, medical equipment and other new listings. The 8 kinds of situations as the risk period, that the new products to market within five years, serious adverse events during the investigation, without obtaining GMP certification period and so on.
"Measures" were the production of pharmaceuticals and medical devices and medical institutions' risk management made a clear link refinement. Among them, the risk of drug production areas including materials management, production management, quality management and authentication management; pharmaceutical distribution according to the specified risk areas include supply units and audit the legality of purchasing drugs, according to the specified storage conditions, drugs, do not have the line Drug characteristics required transport capacity; risk areas, including medical device manufacturing system management, equipment management, production management, quality management, adverse event monitoring and management; medical equipment business risk areas include the employees, storage, purchase and sales; medical risk Medical Device sectors including inspection, storage, use and monitoring.
Jinhua Zhang Xinhua, said the Secretary for Food and Drug Administration, "measures" introduced, will further strengthen the quality and safety of the source of Medical Device risk management, all possible risks to the point of investigation, the establishment of a full range of risk management and control system, protection of fundamental Medical Device quality and safety.
The key in the implementation
"To protect drug safety is a complicated systematic project, the" measures "to implement a major refinement 'overall responsibility for local government, regulatory duties, the firm is primarily responsible for' drug safety responsibility system." Zhang Xinhua said.
"Approach" proposed by the "risk set for duty, the system was built for duty, the responsibility fell on people" requirements, and to post to point to sector block, process-line systems as the surface, interlocking risk control mechanisms, including risk awareness education system, commitment to risk management and control mechanisms, the risk of accountability mechanisms, risk supervision and inspection mechanisms.