Division of drug operations and quality supervision and management

According to the official website of the State Food and Drug Administration, recently, the State Food and Drug Administration publicly requested the latest revised "drug management and use quality supervision management Measures (Draft for Comment)" (hereinafter referred to as "Opinions").

Among them, the "Opinions" clearly, the drug retail enterprises should comply with the national prescription drugs and non-prescription drug classification management systems, and according to the regulations, the prescription is not less than five years.

Drug retail enterprises may not give drugs to the public to give drugs or buy goods from drugs.

Prescription drugs must not be sold.

"Opinions" is divided into total, business license, management, drug use quality management, supervision and inspection, legal responsibility, and seven chapters of the seven chapters.

The "Opinions" requires that drug management enterprises should establish a drug management system in the whole process of covering drugs. Records, storage conditions, transportation processes, quality control, etc. should be complete and accurate, and must not be built and tampered. The licensee holder of the drug list shall establish and improve the drug traceability system in accordance with the regulations, and the sales packaging units of listed drugs will be traced logo, implement the process of the drug.

According to the "Opinions", drug management enterprises shall not operate drugs from drugs, traditional Chinese medicine formulas, etc. Drug retail companies may not sell narcotics, first-class psychotropic, radioactive drugs, pharmaceuticals, toxic chemicals, protein assimilation preparations, peptide hormones (except insulin), and terminate pregnant drugs.

Pharmaceutical listing license holders, relevant qualification materials and purchase and sales records in drug management enterprises should be preserved for one year, and must not be less than five years. When a sudden public health event or other emergency incidents that seriously threaten public health, the drug retail enterprises shall strictly abide by the emergency disposal requirements of the people’s governments at all levels, and take the following items, suspend sales, and other measures as required.

"The Opinions" also clarified cross-regional supervision responsibility.

Drug listing license holders, drug management enterprises and trusted drug management related activities are not in the same province, autonomous region, municipality, by drug listing license holders, drug management enterprises, autonomous region, municipality, drug supervision and management department Responsible for the supervision and management of drug listing permitholders, drug management enterprises, the provinces, autonomous regions, and municipalities directly under the Central Government, are responsible for supervision and management of the trustee.

The two sides should strengthen information communication, and will not report to each other in a timely manner, and the joint inspection can be carried out if necessary. The State Food and Drug Administration said that in order to implement the "Drug Administration Law of the People’s Republic of China", the State Drug Administration organized the drafting of "Medical Management Supervision and Administration], in September 2019, the State Drug Administration has disclosed opinions on September 2019.

After revision and improvement, "The Administration of Drug Administration and Quality Supervision" is now exposed to the public to discuss advice.