Chapter 1 General Provisions Article 1 In order to strengthen the management of preparations by medical institutions and standardize the application and approval of preparations by medical institutions, in accordance with the "Drug Administration Law of the People's Republic of China" (hereinafter referred to as "Drug Administration Law") Law) and the "Regulations for the Implementation of the Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Implementation Regulations of the Drug Administration Law"), these Measures are formulated. Article 2 These Measures shall apply to applications for preparation, dispensing and use of preparations by medical institutions within the territory of the People's Republic of China, as well as related approval, inspection and supervision. Article 3 Medical institution preparations refer to fixed prescription preparations prepared by medical institutions for their own use with approval based on the clinical needs of the unit.
Preparations prepared by medical institutions should be varieties not available on the market. Article 4 The State Food and Drug Administration is responsible for the supervision and management of preparations produced by medical institutions across the country.
The (food) drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the approval, supervision and management of preparations by medical institutions within their respective jurisdictions. Article 5 Applicants for medical institution preparations shall be medical institutions that hold a "Medical Institution Practice License" and obtain a "Medical Institution Preparation License".
Medical institutions in the "hospital" category that have not obtained a "Medical Institution Preparation License" or a "Medical Institution Preparation License" that does not have a corresponding preparation dosage form can apply for medical institution traditional Chinese medicine preparations, but they must also submit a commission to prepare the preparations. application. The unit that accepts entrusted preparation shall be a medical institution that has obtained the "Medical Institution Preparation License" or a pharmaceutical manufacturer that has obtained the "Good Manufacturing Practice for Pharmaceutical Products" certification. The dosage forms of preparations entrusted to be prepared shall be consistent with the scope stated in the "Medical Institution Preparation License" or "Good Manufacturing Practice" certification held by the entrusted party. Article 6 Preparations prepared by medical institutions can only be used within the medical institution with the prescription of a practicing physician or a practicing assistant physician, and shall be consistent with the scope of diagnosis and treatment specified in the "Medical Institution Practice License". Chapter 2 Application and Approval Article 7 When applying for preparations from medical institutions, corresponding preclinical research should be conducted, including prescription screening, preparation technology, quality indicators, pharmacology, and toxicology research, etc. Article 8 The information submitted when applying for registration of pharmaceutical preparations by medical institutions must be true, complete and standardized. Article 9 The chemical raw materials used in the preparations being applied for and the Chinese herbal medicines and Chinese herbal pieces managed by approval numbers must have drug approval numbers and comply with statutory drug standards. Article 10 The applicant shall provide a description of the patent of the applicant or others in China and its ownership status for the preparation applied for registration or the prescription, process, purpose, etc.; if someone else has a patent in China, the applicant shall submit a copy of the patent. A statement that other people’s patents do not constitute infringement. Article 11: The names of preparations produced by medical institutions shall be named in accordance with the drug naming principles promulgated by the State Food and Drug Administration, and trade names shall not be used. Article 12 The excipients used by medical institutions to prepare preparations and packaging materials and containers that come into direct contact with the preparations shall comply with the State Food and Drug Administration’s regulations on the management of excipients and packaging materials and containers that come into direct contact with drugs. Article 13 The instructions and packaging labels for preparations produced by medical institutions shall be approved by the (food) drug regulatory authorities of the provinces, autonomous regions, and municipalities directly under the Central Government when approving the preparation application based on the information submitted by the applicant.
Instructions and packaging labels for preparations produced by medical institutions should be printed in accordance with the State Food and Drug Administration’s regulations on drug instructions and packaging labels. Their text and graphics must not exceed the approved content, and must be marked with "this document". Preparations are for use by this medical institution only." Article 14: Preparations for medical institutions shall not be declared under any of the following circumstances:
(1) Varieties already available on the market;
(2) Contains substances that have not been approved by the state Types of active ingredients approved by the Food and Drug Administration;
(3) Biological products other than allergens;
(4) Traditional Chinese medicine injections;
(5) Compound preparations composed of traditional Chinese medicine and chemical drugs;
(6) Narcotic drugs, psychotropic drugs, toxic drugs for medical use, and radioactive drugs;
(7) Other non-compliance Preparations stipulated by relevant national regulations.
Article 15 To apply for the preparation of preparations for medical institutions, the applicant shall fill in the "Application Form for Registration of Preparations for Medical Institutions" and submit it to the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where it is located or the districted municipal (food) drug administration department entrusted by it. The regulatory agency submits an application and submits relevant information and samples of preparations. Article 16 The (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government that receives the application or the district-level (food) drug regulatory agency entrusted by it shall conduct a formal review of the application materials and accept them if they meet the requirements; If the requirements are met, the applicant shall be notified in writing within 5 days from the date of receipt of the application materials and the reasons shall be stated. If the application is not notified within the time limit, the application shall be deemed to be accepted from the date of receipt of the materials. Article 17 The (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government or the district-level (food) drug regulatory agency entrusted by it shall organize an on-site inspection within 10 days after the application is accepted and draw three consecutive batches of samples for inspection. , notify the designated drug testing institute to conduct sample inspection and technical review of quality standards. The entrusted municipal (food) drug regulatory agency divided into districts shall, after completing the above work, submit the review opinions, inspection report and application materials to the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, and notify the applicant.