Article 4 Medical institutionsshould be establishedPharmaceutical quality management system, for the unit of drugsPurchase, storage, useThe whole processis responsible for the quality management of drugs. Where radiopharmaceuticals and other drugs under special management are used, relevant use permits shall be obtained in accordance with regulations.
Other drug users other than medical institutions, shall comply with the provisions of these measures on the drug quality management of the whole process of drug purchase, storage and use in medical institutions.
Interpretation of Provisions:
This article is a regulatory requirement for the use of drugs by medical institutions and other drug users.
Highlighting the "drug quality management system" and "the whole process of drug quality management is responsible" two requirements, it looks like a very strict requirement, but combined with the division of regulatory responsibilities in the second paragraph of Article 6, the quality management of drug use in medical institutions is borne by the municipal and county-level drug regulatory departments, and the responsibility part is with reference to retail pharmacies, the highlights of this article are not easy to say in reality. Whether the country's well-known public hospitals can really implement supervision is still a big question mark.
The use of radiopharmaceuticals requires a separate license, which is also done nowadays, and is generally used in the nuclear medicine department of the hospital.
Article 5 Drug marketing authorization holders, drug dealers and medical institutions shall comply with the unified drug traceability standards and specifications formulated by the State Drug Administration, and establish and implement themDrug traceability systemProvide traceability information in accordance with regulations to ensure the traceability of drugs.
Interpretation of Provisions:
This article is about the continued implementation of the "drug information traceability system". The drug traceability system is also mentioned many times in the Measures for Online Sales of Drugs.
Information traceability has always been the work that NMPA has vigorously promoted, and every code must be scanned, although in recent years, in addition to special drugs, blood systems, and centralized procurement, there seems to be no new type of variety required to scan the code. This system is good, but in reality there is still a lot of resistance, and the illegal circulation of drugs (hospitals to pharmacies) still exists.
Article 6 The State Drug Administration is in charge of the supervision and administration of the quality of drug operation and use nationwide, and supervises the drugs of provinces, autonomous regions and municipalities directly under the Central GovernmentThe management department shall guide the supervision and management of the quality of drug operation and use.
The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the supervision and management of the quality of drug operation and use within their respective administrative regions, and are responsible for the licensing, inspection and punishment of drug wholesale enterprises and drug retail chain headquarters, as well as the inspection and punishment of the sales behavior of drug marketing authorization holdersAccording to their duties, guide the supervision and management of drug operation and use quality of the departments of the people at the municipal and county levels divided into districts and counties (hereinafter referred to as the municipal and county-level drug regulatory departments).
The drug regulatory departments at the municipal and county levels are responsible for the supervision and management of the quality of drug operation and use within their respective administrative areas, and are responsible for the licensing, inspection and punishment of drug retail enterprises, as well as the inspection and punishment of the quality of drug use.
The State Administration for Market Regulation is to strengthen the guidance of the comprehensive law enforcement team for market regulation in accordance with relevant provisions.
Interpretation of Provisions:
This article is about the division of responsibilities of the ** drug regulatory departments at all levels.
NMPA: Nationwide Supervision + Guidance for Provincial Supervision;
Provincial Bureau: Responsible for the inspection and punishment of MAH, drug wholesale enterprises, and drug retail chain headquarters + guidance at the city and county levels.
Municipal and county bureaus: responsible for the supervision of drug retail enterprises and the supervision of drug use.
SAMR: Strengthen the guidance of the comprehensive law enforcement team for market regulation.
Article 7 The State Drug Administration formulates the good management standards for drug operation and the guiding principles for on-site inspection. The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government may formulate inspection rules in accordance with these measures, the drug business quality management standards and their on-site inspection guidelines, and the actual situation of their respective administrative regions.
Interpretation of Provisions:
This article is a provision that gives local drug regulators the right to formulate their own inspection rules.
The "Good Manufacturing Practice for Pharmaceutical Operations" here refers to the GSP specificationThe on-site inspection guidelines refer to the "Guiding Principles for On-site Inspection of Good Manufacturing Practices for Pharmaceutical Operations" issued by the former CFDA, which is often referred to as "Article 256" in practice.
"Article 256" is the guiding principle of inspection at the national level, and due to different circumstances, various localities will make certain changes to "Article 256" in actual operation, but there are no laws, regulations and rules and policies that explicitly allow local regulatory authorities to change the implementation of "Article 256", which leads to the fact that local regulatory departments do not dare to publish their own regional regulatory rules, and more in the form of window guidance, internal documents, etc., which actually violates the principle of the rule of law.
After the promulgation of the "management measures", the local regulatory authorities have been given the right to formulate inspection rules, and can openly publish the regulatory rules in the region, which is actually beneficial to the industry.
In addition, the local inspection rules can be higher than the inspection rules stipulated by the state, but not lower than the inspection rules stipulated by the state.
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