According to the Provisions for Drug Recall, the manufacturing enterprise is the main principal part for drug recall. The manufacturer should set up and perfect the system of drug recall, collect relevant information on drug safety, do investigation and evaluation for the drug that possibly exists safety risk., and recall the drug with safety problem.
The manufacturer should set up and perfect quality assurance system and the monitoring system of drug adverse actions, collect and record drug quality problems and adverse action problems, and report the relevant information to drug supervision administration in time.
According the recall grades and sales and using situation, the manufacturer should make scientific recall plan and implement. In the recall plan, the release ways and release areas of the recall bulletin must be included. In the provisions, there are relevants rules on the implement process of voluntary recall and compulsory recall.
In the process of drug recall, drug distributor and medical organization also have relevant responsibility. They should cooperate with manufacturer to announce the recall bulletin, controll and withdrawl the drugs with safety problems.
When finding the safety problems, drug distributor and medical organization should stop saling or using the drugs with safety problems, and report to drug supervision administration.
For the recall of imported drugs, the foreign manufacturer is main principal part. The recall process should accord with relevant rules. According to the provisions, the recall of imported drugs in foreign countries should be reported to SFDA, so that SFDA can better control the risk of imported drugs.