Regulations on the Implementation of Measures for Drug Surveillance of Medical Institutions in Beijing (Consultation Draft)

Chapter I General Provisions Article 1 To strengthen the supervision and administration of drugs in medical institutions and ensure the safe and effective use of drugs, in accordance with the "People's Republic of China Drug Administration Law" (hereinafter referred to as the "Drug Administration Law") and the "Regulations of the People's Republic of China on Drug Administration Law" ( The "Administrative Regulations of the Drug Administration Law", the "Administrative Measures for the Distribution of Drugs", the "Measures for the Supervision and Administration of Drugs for Medical Institutions (Trial)" and other laws, regulations, and regulations shall be hereinafter referred to, and the Detailed Rules shall be formulated in light of the actual conditions in the city.

Article 2 These Rules shall apply to the purchase, storage, deployment, use of pharmaceutical quality management and supervision and management of the above-mentioned behaviors by medical institutions within the administrative regions of Beijing.

Article 3 The Beijing Municipal Drug Administration Bureau (hereinafter referred to as the Municipal Food and Drug Administration) shall be responsible for the supervision and administration of drugs in medical institutions throughout the city. The sub-bureaus of the Beijing Municipal Drug Administration (hereinafter referred to as the “Pharmaceutical Surveillance Branches”) shall be responsible for the daily supervision and administration of drugs in the medical institutions in their respective jurisdictions.

Article 4 Medical institutions shall establish and improve a drug quality management system, establish a pharmacy management organization in accordance with relevant regulations, and have full-time personnel in the pharmacy department responsible for the daily management of drug quality.

Clinics, health clinics, clinics, health clinics, health stations, and Chinese medicine (ethics) clinics may be designated medical personnel by the head of the organization or professional technicians of traditional Chinese medicine (ethnic medicine) to take charge of drug quality management.

Article 5 Medical institutions shall formulate various management systems for ensuring the quality of medicines. Hospitals at or above the second-level (including level 2) and other medical institutions that are eligible shall establish purchase, acceptance, storage, storage, maintenance and export of medicines. Library, deployment and other important aspects of the operating procedures, and clear the staff members of each link in the responsibilities.

Article 6 Medical institutions shall be equipped with appropriate departments or personnel according to the scale of diagnosis and treatment, and be responsible for the specific work of the purchase, storage, deployment and use of drugs.

Article 7 Medical institutions are responsible for the quality of medicines purchased, stored, deployed and used.

The person in charge of the medical institution shall ensure that this institution strictly implements the various laws, regulations and rules of the national drug administration, and bears leadership responsibility for the quality of the drugs within the institution. The person-in-charge, full-time staff or designated staff of the pharmaceutical department shall strictly implement the various management systems of the institution and bear the management responsibility for the quality of the medicine within the institution.

Article 8 Medical institutions shall regularly organize personnel engaged in drug quality management to participate in the training of pharmacy regulations and pharmacy professional knowledge, and establish training files.

Article 9 Medical institutions shall gradually establish an electronic management system covering the whole process of drug purchase, storage, deployment, and use, so that the traceability and destination of drugs can be ascertained.

Chapter II Purchase of Pharmaceuticals Article 10 Medical institutions must purchase medicines approved by the State Food and Drug Administration from pharmaceutical production and trading enterprises that have the Pharmaceutical Production License and the Pharmaceutical Trade License.

A medical institution that has a pharmacy management organization shall be responsible for the procurement of drugs used by its own organization. The pharmacy management organization shall be responsible for the procurement of the drugs used by the organization. If no pharmacy management organization is established, it shall appoint someone to be responsible for the procurement of the drugs used by the institution. Medical institutions must not sell or use medicines purchased through non-normal channels.

If a medical institution urgently needs to import a small amount of drugs for clinical purposes, it shall apply to the State Food and Drug Administration with a “Practice Permit for Medical Institutions” and can only import after approval. Imported drugs should be used for specific medical purposes within designated medical institutions.

Article 11 When a medical institution purchases drugs, it shall obtain the following valid materials from the supplier, and establish archives for preservation:

(1) Copies of the "Drug Production License" or "Drug Business License" stamped with the original seal of the supplier;

(2) A copy of the Business License stamped with the original seal of the supplier;

(3) Copies of the "Pharmaceutical Production Quality Management Practice" or "Pharmacy Business Quality Management Practice" certification stamped with the original seal of the supplier;

(4) Where a drug is purchased directly from a pharmaceutical production enterprise, a copy of the drug approval certificate affixed with the original seal of the production enterprise shall also be obtained, except for the Chinese Herbal Pieces not under the approval number;

(5) The power of attorney signed or sealed by the legal representative of the company, and the power of attorney shall state the identity card number of the variety, territory, time limit, and salesperson authorized to sell;

(6) A copy of the salesperson's ID card and a photocopy of the salesman's certificate stamped with the original seal of the supplier;

(7) Signing quality assurance agreements or contracts with clear quality provisions;

(8) Other materials requested by the drug regulatory department.

Article 12 The medical institution shall conduct an audit of the first supplier, including production and business qualifications and quality assurance capabilities. The legality and quality of the medicines purchased for the first time from drug manufacturers are reviewed. The contents of the review include the validity of drug approval numbers and quality standards, as well as the conformity of the contents and forms of drug packaging, labels, and manuals.

The medical institution shall check the original identity card of the salesperson and the original certificate of the salesman.

Article 13 A medical institution shall periodically review and confirm the qualifications and quality assurance capabilities of its drug supply unit.

Article 14 The medical institutions are encouraged to make full use of the existing drug supervision and management information systems to purchase drugs from drug production and operating companies that have connected product traceability systems. Where drugs are purchased from an enterprise that is connected to the product traceability system, it is not necessary to retain the qualification certification documents required by items (1) to (4) of Article 11 of these Rules.

Article 15: When a medical institution purchases drugs, it must obtain and retain the legitimate bills of the supplier and establish a purchase record so that the votes, accounts, and objects match.

The legal documents include tax invoices and detailed lists. The list must indicate the supplier's name, drug name, specifications, manufacturer, batch number, quantity, price, etc. The period of reservation of the bill shall not be less than 3 years.

Article 16 Medical institutions must establish and implement a purchase acceptance system. Purchased drugs should be approved on a batch-by-batch basis. The main inspection contents and requirements include:

(1) Drug certification documents;

(b) the integrity of pharmaceutical packaging;

(3) The pharmaceutical packaging shall be printed or affixed with the label and attached with the instructions in accordance with the regulations;

(4) The Chinese Herbal Pieces should be packaged, and the name, manufacturer, date of manufacture, batch number, etc. of each package should be indicated;

(5) To purchase medicines that need to maintain the cold chain transportation conditions, it is necessary to check whether the transportation conditions are in compliance with the prescribed requirements, and to make records; if they do not meet the requirements of the transportation conditions, they shall refuse to accept them.

Medical institutions that accept donated drugs and transfer them from other medical institutions should also strictly abide by the provisions of the preceding paragraph and perform inspections and records on a batch basis.

Article 17 Medical institutions must establish a true and complete record of the purchase of drugs. Purchase records must indicate the generic name of the drug, manufacturer, dosage form, specifications, lot number, date of manufacture, date of validity, approval number, supplier, quantity, price, purchase date, acceptance date, acceptance conclusion, and so on.

Purchase records shall be kept for a certain period of time for future reference, and after the expiry of the prescription of the drug in question, they shall be approved and registered by the person in charge of drug quality management at the medical institution and may be destroyed simultaneously with the prescription.

Where drugs are purchased from pharmaceutical production and operating companies that have been linked to the drug traceability system, the accompanying list may be used as a purchase record if the items on the accompanying list are complete. The inspector shall record the acceptance date and acceptance conclusion on the list and sign it for confirmation.

Article 18 Medical institutions shall establish a procurement system for Chinese herbal medicines.

Medical institutions purchasing from TCM decoction pieces must require companies to provide certification documents and quality inspection reports of the purchased products; in addition to requesting certification of the qualifications of the operating companies, they must also request the production of purchased products. The company's "Drug GMP Certificate" and quality inspection report.

Medical institutions may not purchase Chinese Herbal Pieces from the Chinese medicinal materials market or other entities and individuals that are not legally qualified for dispensing.

Chapter III Drug Storage Article 19 A medical institution shall have a drug store or pharmacy suitable for the scale of diagnosis and treatment and the drugs used, equipped with temperature control, moisture protection, light protection, ventilation, fire prevention, pest control, rodent control, and pollution prevention. Facilities and equipment, according to drug properties, categories, storage conditions, store drugs to ensure the quality of drugs.

Article 20 Drug storage in medical institutions must meet the following requirements:

(1) TCM decoction pieces, proprietary Chinese medicines, and chemical drugs are separately stored, and the internal medicine and external medicine are stored separately.

(2) Qualified drugs are placed in green banks (districts), drugs to be tested are placed and returned drugs are placed in yellow libraries (zones), unqualified drugs are placed in red banks (zones);

(3) The varieties of drugs are stored according to the lot number, and the location is relatively fixed. The storage conditions and placement methods must comply with the pictorial symbols and textual requirements for the outer packaging of medicines, and there must be a certain distance or isolation between ground, walls, ceilings and radiators.

Article 21 If a medical institution does not have a drug storehouse, the scale of the pharmacy should be appropriate, the layout is reasonable, the environment is clean and tidy, there is no source of pollution, and it meets the drug storage requirements and safety requirements. Qualified drugs are strictly separated from the drugs to be tested, drugs returned, and drugs that are not qualified. There are measures to prevent drug confusion and to shorten the shelf life of drugs as much as possible.

Article 22 Where a medical institution needs to temporarily store medicines in places such as emergency rooms or ward nurse stations, it shall be equipped with counters and necessary equipment that meet the requirements for drug storage, ensuring that the medicines are stored in accordance with the conditions specified in the package or instructions, and Personnel regularly manage the quality of the medicines stored and their expiration date.

Article 23 Medical institutions shall formulate and implement a drug storage and maintenance management system, provide necessary maintenance equipment, take necessary maintenance measures, and ensure the quality of drugs.

Article 24 Medical institutions shall periodically maintain and inspect stored drugs according to the turnover of drugs, maintain storage facilities and equipment, and establish drug maintenance files.

The quality of unqualified drugs must be managed in a controlled manner, reported and handled in accordance with the prescribed procedures and requirements. The procedures for the reporting and destruction of non-conforming drugs should be improved.

Article 25 A medical institution shall establish a system for the management of the effective period of drugs. When drugs are released, issued and used, the drugs shall be reviewed and quality checked.

Chapter IV Distribution of Drugs Article 26 A medical institution must adjust the prescription of a licensed doctor or assistant practicing physician within the scope of an approved medical treatment subject.

The pharmacy of a medical institution shall deal with internal settings and shall not open a window for selling drugs on the street, nor may it engage in drug business activities.

Article 27 Medical institutions shall be equipped with pharmacy technicians qualified in accordance with the law according to laws and regulations that are in line with the deployment of drugs, and shall be responsible for the examination and allocation of prescriptions.

Article 28 When a medical institution deploys and uses drugs, it shall correctly explain to the users of the drugs such matters as usage, dosage, contraindications and special storage conditions.

Article 29: Clinical departments of medical institutions may not set up pharmacies privately, and medical personnel may not sell drugs and preparations privately.

Article 30: The medical institutions' tools, facilities, packaging supplies and areas for the deployment of pharmaceuticals for the distribution of pharmaceuticals shall meet the requirements for hygiene and quality and shall not cause any pollution to the pharmaceuticals.

Article 31 If a medical institution provides Chinese Herbal Decoction on behalf of the decoct, it shall have a dedicated place and facilities, and shall establish a management system and record for decocting on behalf of the Chinese Herbal Decoction.

Article 32 A medical institution shall establish a management system for the zero-clearing and blending of minimum-packaged drugs to ensure that the quality of drugs can be traced back.

Article 33 Medical institutions shall not sell prescription drugs directly to the public by means of postal sales, Internet transactions, counter-opening, etc., and may not sell drugs by means of free clinics, bazaars or trials.

Chapter V Supervision and Administration Article 34 Medical institutions shall do a good job in drug quality management of their own institutions and strengthen the quality control over the whole process of drug use.

If a medical institution discovers that the drugs used are fake drugs or inferior drugs, they must be immediately stopped from use, sealed on the spot and properly kept, and reported to the drug supervisory office of the place of registration in a timely manner; before the drug regulatory department makes a decision, the medical institution must not handle it without authorization.

If a medical institution discovers that there is a potential safety hazard in the use of a drug, it shall immediately stop and inform the drug manufacturer or supplier and report it to the drug supervisory office of the registered place; if a recall is required, the medical institution shall assist the drug manufacturer to perform the recall obligation.

Article 35 A medical institution shall organize personnel who are in direct contact with the drug to conduct at least one health examination every year, establish a health record, and ensure that it is competent for the position in which it is engaged. Any person found to have a mental illness, infectious disease, or other disease that may contaminate a drug should immediately be removed from the job.

Article 36 A medical institution shall establish an annual self-inspection reporting system for drug quality management. Each year, the organization's drug administration shall be collated and summarized, and the annual self-inspection report shall be submitted to the drug administration office of the registered place before December 31 of each year.

The self-inspection report shall reflect the scale and characteristics of the medical institution and faithfully reflect the pharmaceutical quality management situation of the institution, and at least cover the following contents:

(1) The pharmacological classification and number of drugs used, the route of administration and the number of varieties, the total amount of drugs purchased this year, the number of new varieties added, and the number of varieties cancelled;

(2) The formulation, revision and implementation of the pharmaceutical quality management system;

(3) undertaking or entrusting medical institutions to formulate, transfer or transfer preparations for the preparation of medical institutions, and the use of the above-mentioned preparations;

(4) The number of inspections, problems and rectifications that have been accepted by the Drug Administration Sub-bureau, and the number of batches of inspection drugs, inspection results and handling of non-conformity results received by the supervisory spot checks;

(5) Opinions and recommendations on the work of the drug regulatory department.

Article 37 Each drug administration sub-bureau shall supervise and inspect the overall situation of drug quality management of medical institutions and the specific work of drug purchase, storage, and deployment in accordance with their duties, and shall put forward handling opinions when problems are found.

If the problems found in the inspection need to be handled by other departments, they shall be promptly transferred to the Association for investigation or processing.

Supervision and inspection activities must not interfere with the normal medical treatment activities of medical institutions.

Article 38 Medical institutions shall actively cooperate with the supervision and inspection and random inspections conducted by the drug supervision and administration departments according to law, provide truthfully the articles, records, vouchers and medical documents relating to the matters to be inspected, and shall not refuse or conceal any of them.

Article 39 Each drug administration branch shall strengthen the supervision, random inspection and inspection of drugs in medical institutions, and the result of the random inspection shall be regularly announced by the Municipal Food and Drug Administration. The drug supervisory bureaus may publish the drug quality inspections in the medical institutions in the jurisdiction within the scope of their duties.

Article 40 The drug administration bureaus shall, according to the actual conditions, establish a credit file for drug quality management of medical institutions in the area, record the results of daily supervision and inspection, report complaints, and investigate and deal with illegal activities.

The establishment of drug quality management credit files can be combined with daily supervision and inspection records to reflect the establishment and operation of drug quality management systems in medical institutions, drug administration organizations and personnel, drug purchase, storage, deployment, annual self-inspection and reporting .

Credit files can be saved in various forms such as paper materials, electronic documents, and databases.

Article 41 Each drug supervisory sub-bureau may determine the key supervision and inspection units according to the credit quality of drug quality management of medical institutions, increase the frequency of supervision and inspection, and increase the intensity of spot checks of drug quality.

Article 42 Where a medical institution purchases drugs from an enterprise that does not have a Drug Production License or a Drug Trade License, it shall be punished in accordance with Article 80 of the Drug Administration Law.

Without the authorization of the pharmaceutical administrative organization of a medical institution to procure the purchase of drugs by itself, the medical institution shall be ordered to give corresponding treatment; if it is determined to be a counterfeit and inferior drug, it shall be punished in accordance with the relevant provisions of the Drug Administration Law.

Article 43 Medical institutions selling prescription drugs directly to the public in the form of mail sales, Internet transactions, counter-opening, etc., or selling drugs by means of free clinics, bazaars, trials, etc., shall be handled in accordance with Article 42 of the "Medicine Distribution Supervision and Administration Measures." Article processing.

Article 44 Medical institutions violate the relevant provisions of these Rules and conceal facts, and fail to truthfully provide materials, records, vouchers, and medical documents relating to the items to be inspected, and obstruct or refuse to accept supervision and inspection, in the Drug Administration Law. "and" "Administrative Regulations for the Implementation of Drugs," the penalties imposed by the heavier punishment.

Article 45 If there is a lack of a drug quality management organization or system in a medical institution, and there are quality problems in the purchase, acceptance, storage, maintenance, and deployment of drugs, the local drug administration sub-bureau shall order it to rectify within a time limit. If it is overdue, it shall be recorded as medical expenses. Institutional drug quality management credit files, and inform relevant health administrative departments.

Article 46 Where a medical institution does not violate the relevant provisions of the "Drug Administration Law" and the "Regulations for the Implementation of the Drug Administration Law," and has sufficient evidence to prove that it does not know that the drugs used are counterfeit or inferior, it shall be confiscated. The counterfeit drugs, inferior drugs and illegal income may be exempted from other administrative penalties.

Article 47 Each drug administration department shall strengthen the education, training, and management of its staff members and perform their duties correctly. Any person who fails to perform his duties or abuses his power, neglects his duties, or engages in malpractices for personal gains shall, in accordance with law, give corresponding administrative sanctions to the directly responsible person in charge and other directly responsible persons; if he is suspected of committing a crime, he shall transfer it to the judicial authorities for disposal.

Chapter VI Supplementary Provisions Article 48 The management of medical institutions' preparation of preparations, use of special management drugs, use of vaccines, and monitoring of adverse drug reactions shall be strictly in accordance with the requirements of relevant laws, regulations and rules, and shall be subject to supervision and inspection.

Article 49 The work of prescription management, preparation, adjustment, preparation of Chinese Herbal Medicines, and preparation of herbal medicines in the process of drug administration in medical institutions shall comply with the relevant provisions of the administrative departments of health and the administrative departments of traditional Chinese medicine.

Article 50 These rules shall come into effect on October 12, 2012.