Food and Drug Administration: learn the lessons of chromium exceeded the capsule event to improve the means of supervision

BEIJING,

, August 6, according to the State Food and Drug Administration website news, August 2 to 3 days, the medical device supervision management forum held in Taiyuan, Shanxi. Party members of the State Food and Drug Administration, the Deputy Secretary stressed that the side of vibration A chromium exceeded medicinal capsules “event for the alarm, lessons learned, and continue to regulate the regulatory behavior, and improve the means of supervision.

side Zhenjia pointed out that the medical device regulation in the first half of 2012, all the work achieved significant results, further deepening of the daily monitoring. However, the current medical device regulatory work still exists the complexity and uncertainty, to continuously improve medical device related regulations and normative documents, clearly the powers and responsibilities of the relationship. Continuous innovation review and approval mechanisms, improve review quality and efficiency standards, coding, classification, and work to strengthen, consolidate the regulatory basis, and constantly refine day-to-day supervision of procedures, strengthen law enforcement deterrent. Strengthen the monitoring of adverse events, and timely feedback problems, and to accelerate the pace of construction of inspection and testing institutions, technical support capabilities.

side Zhenjia stressed that “chromium exceeded medicinal capsule event alarm, lessons learned, giving top priority to fully find all aspects of medical device regulation in risk awareness, regulatory mechanisms, enforcement and technical support, etc. deficiency, further strengthen the sense of responsibility and mission, to govern the people as the guiding ideology, continue to improve the regulatory style, and continue to regulate the regulatory actions to improve the means of supervision.

side Zhenjia said, to further implement the overall responsibility of local governments, regulators responsible for their own, the firm is the first responsibility requirements, high vigilance against systemic risk, and resolutely crack down on the industry’s unspoken rules. Should continue to strengthen capacity-building and team-building, national drug safety “12th Five-Year Plan” for the full implementation of the medical device regulatory various tasks.

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