Each province、Autonomous Region、Food and Drug Administration (Drug Supervision Administration):

The National Bureau of "Announcement on Strictly Implementing the Appraisal of Medicinal Glipper Capsules and Capsule Drugs" (2012 No. 25) and "Notice on Strengthening the Quality Management of Capsules Drugs and Related Products" (National Food Drug Supervisor [2012] No. 18) After sending it off，Earnestly implement the spirit of the document，Actively promote related My stake betting appwork，Submit statistics on a schedule。Analysis according to the situation reported by localities，At present, there are still some self -inspection levels in some enterprises.、Unbalanced progress of self -inspection and drawing in various places，Requirements for the goal of approval inspection，The task is quite difficult。To further implement the medicinal gelatin、Pharmaceutical Capsule and Capsule Drug Application Inspection Requirements，The relevant matters are notified as follows:

1. Make sure the goal of approval inspection work

Chancing for listed drugs is the responsibility of the enterprise，Implementation of batch inspections is an important measure to ensure the quality of the capsule agent drugs。Must be firm goal without shaking，Complete the task on time。Enterprises must not complete the approval inspection for any reason，Drug supervision and management departments of various places must urge enterprises to propose a job plan for approval inspection。Any company that cannot complete the batch inspection on schedule suspension of the production of capsules drugs，Concentration forces to ensure the completion of batch inspection tasks。All the drug batches that have not been completed on June 1，Try to suspend sales and use。Any enterprise self -examination found that unqualified drugs must take the initiative stake betting appto recall，Those who actively recall can be exempted from administrative punishment，Failure to recall，and the strict punishment of unqualified drugs in the supervision and drawing test。

Strong quality guarantee and inspection ability，Pharmaceutical Capsule Purchasing Channel Fixed、Clear，Capsule drug production enterprises that have been approved after purchasing，Careful investigation by the enterprise，Provide effective inspection data，Make a promise of qualified product，After inspection and inspection data review by the provincial drug supervision and management department，Enterprises can not repeat self -test。The list of these companies must be publicized on the website of the provincial drug supervision and management department，Accept social supervision。

Drug supervision and management departments of various places shall strengthen supervision and inspection，Timely grasp the progress of the self -inspection work of the enterprise，It can give necessary coordination and help for the actual difficulties encountered by the company。

2. Improve the coverage of supervision and draw

Products listed before April 30，Supervise and draw inspection after the self -inspection of the enterprise，The proportion of supervision and drawing should not be less than 3%of the production batch of the enterprise;，Capsule agent drug supervision and drawing ratio should not be less than 20%。

Under the above principle，stake betting appIt can be according to the specific situation of the enterprise，Proper adjustment ratio。Comprehensive quality guarantee system、Strong inspection ability，Enterprises that have no bad records in the past，It can be appropriately reduced to the proportion of pumping tests; poor quality assurance system、Weaker self -test ability、A company that has had problems，then increase the ratio of drawing，But the total batch must not be lower than the ratio of 3%and 20%required by the previous paragraph。

Provincial drug supervision and management departments must arrange drug inspection work reasonably，Implement supervision and drawing task。Drug Inspection Institutes at all levels should focus on the supervision and pumping test，Under the premise of ensuring the completion of the supervision and drawing tasks，Fang can accept the entrusted inspection of the enterprise。

3. Carry out market drug quality evaluation in a timely manner

The State Administration will carry out a market capsule drug quality evaluation work nationwide at the end of May，Take a certain percentage of capsule drugs for test，Compare with the early market testing of the market，To evaluate the quality of market drugs，If there are still chromium limited -edition products，Strictly deal with it according to law。

The above provisions are requested to notify the drug production enterprise stake online sports bettingin time in time，Careful implementation。

　　　　　　　　　　　　　　　　　　　　　　　　　　　　    National Food and Drug Administration
　　　　　　　　　　　　　　　　　　　　　　　　　　　　     May 13, 2012