The National Food and Drug Administration Law [2009] 632 was released on September 22, 2009

Food and Drug Administration (Drugs and Drugs Supervision Bureaus) of provinces, autonomous regions, and municipalities directly under the Central Government:

In order to implement the "Opinions of the Central Committee of the Communist Party of China on Deepening the Reform of the Medical and Health Care System" and the "Notice of the State Council on Printing and Distributing the Immediately Implementing Plan for the Reform of the Medical and Health Care System (2009-2011)", we will strengthen supervision and management of essential drug quality and ensure the quality of essential drugs. According to laws and regulations such as the "Drug Administration Law" and "Regulations for the Implementation of the Drug Administration Law," the State Administration has formulated the "Regulations on Strengthening the Supervision and Management of the Quality of Essential Medicines." Is now issued, please follow the implementation.

Annex: Regulations on Strengthening the Supervision and Management of the Quality of Essential Medicines

State Food and Drug Administration September 22, 2009

annex:

Regulations on Strengthening the Supervision and Management of the Quality of Essential Medicines

The first article is to implement the "Opinions of the CPC Central Committee and State Council on Deepening the Reform of the Medical and Health Care System" and the "Notice of the State Council on Printing and Implementing the Immediately Implementing Plan for the Reform of the Medical and Health Care System (2009-2011)" to strengthen the supervision and management of essential drug quality. The basic drug quality is based on the "Drug Administration Law" and the "Regulations for the Implementation of the Drug Administration Law" and other laws and regulations.

Article 2 The State Food and Drug Administration is responsible for organizing, coordinating, supervising, and supervising the supervision and administration of essential drug quality throughout the country; the provincial food and drug supervision and administration department is responsible for organizing the implementation, guidance, and coordination of the supervision and administration of essential drug quality within its jurisdiction; The supervision and management department is responsible for the specific implementation of the quality supervision and management of the production, distribution, and use of essential drugs.
The food and drug supervision and administration departments at all levels shall, according to the principle of division of responsibilities and management of territories, assume their respective responsibilities, earnestly strengthen the supervision and management of the quality of essential drugs, and ensure the quality of essential drugs.

Article 3 The provincial food and drug supervision and management departments shall cooperate with each other to strengthen communication and coordination, establish and improve the information notification mechanism, and strengthen the supervision and management of essential drug quality.

Article 4 The local food and drug supervision and administration departments at all levels shall further strengthen the supervision and management of basic drug quality in urban communities and rural areas, and give full play to the role of the rural drug supervision network in ensuring the supervision and management of essential drug quality.

Article 5 The term "essential pharmaceutical manufacturing enterprises and distribution companies" as mentioned in the present Provisions refers to the pharmaceutical production and business enterprises that have won the bids for the procurement of essential drugs and the distribution of public tenders organized by the organizations designated by the provincial people's government.

Article 6 The essential drug manufacturing enterprises shall actively carry out research and revision of drug standards, and improve and improve drug standards.
The State Food and Drug Administration organizes the evaluation of standards for essential drugs one by one, and accelerates the promotion of basic drug standards. For those who need to improve the standards, the basic pharmaceutical manufacturing enterprises shall complete the revision of the standards as required; if there are different standards for the same medicine, the State Food and Drug Administration shall, in accordance with the principle of the advanced nature of the standards, make unified improvement.
The Ministry of Health prioritized the criteria for essential drugs into the "Pharmacopoeia of the People's Republic of China."

Article 7 A basic pharmaceutical production enterprise shall, based on the characteristics of the drugs used by the primary health care institutions and other medical institutions at different levels, adopt proper packaging and facilitate the use of the basic drugs while ensuring the quality of essential drugs.
Changes in basic drug dosage form and specifications must be handled in strict accordance with the provisions of the "Drug Registration Regulations."

Article 8 The basic pharmaceutical manufacturing enterprises shall carry out self-examination of prescriptions and processes, aim at the characteristics of large-scale production of basic drugs and lots of batches, organize production in strict accordance with the “Standards for Quality Control of Pharmaceutical Production,” establish and implement a system of quality rights-holders, and improve Quality management, strengthen risk control system construction, strengthen management of raw material procurement, feed, process control and verification, product inspection, release, and other aspects to ensure the quality of drugs.

Article 9 The provincial food and drug supervision and administration department shall organize the examination of the prescription and technology of the essential pharmaceutical production enterprises, and establish a verification product file for essential drug production. If the verification results do not meet the requirements, the enterprise may not organize production.

Article 10 The provincial food and drug supervision and administration department shall, in accordance with the record of the integrity of the production enterprise and the situation of past supervision and inspection, rationally arrange the supervision resources, increase the efficiency of supervision, and strengthen the supervision and inspection of the essential drug manufacturing enterprises within its jurisdiction. The annual routine inspections are not allowed. Less than twice. To promptly urge enterprises to rectify the problems found during the inspection. Those who have violated the law shall be investigated and dealt with in accordance with the law, and the result of the investigation shall be notified to the provincial basic drug procurement agency.

Article 11 The State encourages and promotes the merger and reorganization of essential drug distribution companies, integrates distribution resources, develops modern logistics, and improves drug distribution capabilities.
The distribution companies of essential drugs shall strictly comply with the requirements of the "Practice of Pharmaceutical Quality Management" and strengthen the management of the purchase, acceptance, storage, delivery, and transportation of essential drugs. For drug distribution in rural areas and remote areas, corresponding measures must be taken in accordance with drug packaging, roads, and weather conditions to prevent adverse factors in the transportation process from affecting drug quality.

Article 12 The provincial food and drug supervision and administration department shall strengthen the supervision and administration of basic medicine distribution enterprises, investigate and deal with the illegal acts found during the supervision and inspection according to law, and notify the basic drug procurement agencies of the province about the investigation results.

Article 13: Medical institutions and retail pharmacies must, in accordance with regulations, strengthen the management of the purchase, acceptance, storage, and deployment of essential drugs and ensure the quality of essential drugs. Retail pharmacies should give full play to the role of pharmacists such as licensed pharmacists and guide patients in rational drug use. The food and drug supervision and administration departments shall strengthen the daily supervision and inspection of the quality of essential drugs of medical institutions and retail pharmacies, investigate violations of the law in violation of law, and promptly report the result of investigation and treatment of medical institutions to the health administrative department at the same level.

Article 14 The State shall implement full-species coverage and random inspection of essential drugs, and shall promptly publish the results of random inspections to the public.
The State Food and Drug Administration organizes sampling tests for essential medicines, and increases the sampling ratio of essential medicines in the annual drug sampling plan.
The provincial food and drug supervision and administration department shall formulate an annual plan for supervised random inspection of essential drugs, organize, coordinate and supervise the supervision and inspection of essential drugs within the jurisdiction, and at least conduct a random inspection of essential drugs produced by the basic pharmaceutical manufacturing enterprises in the jurisdiction. The food and drug supervision and administration department at or above the county level shall, in accordance with the actual conditions of its own jurisdiction, strengthen the supervision and inspection of the essential drug operating companies and users in the jurisdiction.

Article 15 The basic drug production and distribution enterprises, medical institutions and retail pharmacies shall establish and improve reports on adverse drug reactions, investigations, analysis, evaluation and treatment systems, and actively monitor, analyze, handle, and report adverse drug reaction information in a timely manner. Hidden dangers shall be promptly recalled as required.
The food and drug supervision and administration departments at all levels should further strengthen the reporting and monitoring of adverse drug reactions, analyze and evaluate case reports of adverse drug reactions to essential drugs in a timely manner, and improve the early warning and emergency handling mechanisms for drug safety.

Article 16 The State Food and Drug Administration organizes the re-evaluation of essential drug species and promptly informs the Ministry of Health of the re-evaluation results.

Article 17 The State gradually incorporates essential drug varieties into the electronic supervision of drugs. The specific implementation steps shall be separately provided by the State Food and Drug Administration.

Article 18 The provincial food and drug supervision and administration department shall promptly submit to the State Food and Drug Administration the directory of essential drug manufacturing enterprises in their respective jurisdictions and the directory of essential pharmaceuticals and essential drug distribution enterprises produced by them. The list of enterprises and products should be published on the relevant government websites.

Article 19 These regulations shall come into force as of the date of promulgation.