From October 1st, Shandong will implement the quality management specifications of new revised drugs

Recently, the Shandong Provincial Drug Administration and the Shandong Provincial Health and Health Commission jointly issued a new revised "Specification". The new revised "Specifications" will be implemented from October 1, 2022, and will be valid until September 30, 2027.

Newly revised the General Principles, Institutions and Persons, Pharmaceutical Purchase and Acceptance, Pharmaceutical Storage and Maintenance, Drug Allocation, Systems and Management, and Affiliated, with a total of 70. Compared with the current "Specifications" Modify to different degrees.

The new revision of the "Specifications" is more suitable for the relevant requirements of the newly revised Drug Management Law. For example, the new revision of the "Specifications" emphasizes the management of the traceability of drugs, and in the "General Principles", "drug use people should establish and implement the drug traceability system in accordance with the law, provide traceability information in accordance with regulations, ensure the traceability of the drugs", and "trace the drug traceability of the drug traceability" Management "included in the main content of the quality management system of drug use; in the chapter of" drug purchase and acceptance ", the qualification of the main body of upstream suppliers increases the" drug listing permit holder "and so on.

The new revised "Standards" also further refined relevant regulations such as the "Regulations on the use of Drugs of Shandong Province". According to the "Regulations on the use of Drugs in Shandong Province", the new revised "Specifications" put forward requirements for the purchase inspection of drugs and electronic data. When purchasing medicines for drugs, the drug must strictly review the qualifications of the supplier, the purchase of drugs and sales staff. Establish a supplier file and list the list of information. The new revised "Standards" also in accordance with the relevant requirements of the "Regulations on Anesthesia Drugs and Psychiatric Drug Management" and "Regulations on the Management of Medical Institutional Pharmaceuticals", respectively. Essence

The new revision of the "Specifications" focuses on the role of "three medical linkage". After negotiation, the new revised "Specifications" jointly issued by the Shandong Provincial Drug Administration and the Shandong Provincial Health and Health Commission, and highlights the departments in the work of fake and inferior drug disposal, drug warning investigation, and strictly implement the responsibility for drug quality management of medical institutions. Play active role.

The newly revised "Specification" also absorbs effective experience and practices in the grassroots practice, and refined the content of some terms to facilitate effective grasp and use in grassroots practice. For example, when buying medicines, the qualification requirements of upstream suppliers clearly add "unilateral samples, invoices, seal seals, and public accounts" on the qualification requirements of upstream suppliers; Tools, on the road temperature records and records the relevant vouchers; in the pharmaceutical storage link, it is clearly stored separately for the partitions of non -qualified drugs, increasing the requirements for drug management during the near -effect period, and clearly registering the drugs in time Conditional medicers use information technology for management "and so on.

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