Medical institutions preparation, subject to provincial, autonomous regions and municipalities directly under the Central People's Government of the health administrative department of the provincial, autonomous regions and municipalities directly under the Central People's Government of the drug supervision and management department for approval, issued by the "medical institutions preparation license", no preparation license, not to be prepared preparations.
"Preparations for medical institutions" license, valid for five years, before the expiration of the validity period, the need to continue to formulate preparations, medical institutions should be in the license expires six months before, in accordance with the provisions of the application for reissue of the "Preparations for Medical Institutions License".
Application for approval of preparations for medical institutions:
Basis:
1, "Chinese People's Republic of China *** and the State Drug Administration Law" (Decree of the President of the People's Republic of China *** and the State of China, No. 45, Article 25)
2, "Measures for the Administration of Registration of Preparations for Medical Institutions" (Decree of the Bureau of the 20th)
3, "Drug Packaging, Labeling and Instructions Management Regulations (Interim) (State Drug Administration Decree No. 23)
4, "Drug Packaging, Labeling Specification Rules (Interim)" (State Drug Supervision Note [2001] No. 482)
Charges: Fees
Charges based on:
"The State Planning Commission, the Ministry of Finance on the adjustment of the drug approval, inspection fees Notice" [Price (1995) No. 340]
Total time limit: 20 working days from the date of acceptance (excluding delivery time)
Acceptance scope: the province's administrative area within the medical institutions apply for preparation by the Provincial Food and Drug Administration acceptance.
Licensing procedures:
Medical institutions to formulate preparations, should be the unit's clinical needs and the market does not supply the varieties.
Acceptance
1, the medical institution preparation registration declaration information requirements
2, the medical institution preparation transfer use declaration information items
3, the medical institution preparation re-registration declaration information items
4, the medical institution preparation related to the application form and the approval format
A, the medical institution preparation registration declaration information Requirements
(A), the declaration of information items
1, the name of the preparation and naming basis.
2, the establishment of the title and the market supply of the variety.
3, supporting documents.
4, labeling and specification design samples.
5, prescription composition, source, theoretical basis and the use of background.
6, research information on the preparation process and literature.
7. Experimental information and literature on quality studies.
8. Draft quality standards and drafting instructions for the preparation.
9. Stability test data of the preparation.
10, the sample of the self-test report.
11, the source of excipients and quality standards.
12, direct contact with the preparation of packaging materials and containers based on the selection and quality standards.
13, the main pharmacodynamics test data and literature.
14, acute toxicity test information and literature.
15, long-term toxicity test information and literature.
16, clinical research program.
17, Clinical study summary.
(ii), description
1, information item 3 supporting documents include:
(1) "medical practice license" copy, "medical institution preparation license" copy;
(2) medical institution preparation or use of prescription, process, etc., and its ownership of the patent situation and ownership status statement, as well as other people's patents do not constitute an infringement of the Guarantee;
(3) to provide the legal source of chemical raw materials, including: approval of the raw materials, sales invoices, test reports, drug standards and other information copies;
(4) direct contact with the preparation of packaging materials and containers, a copy of the certificate of registration;
(5) "medical institution preparations for clinical research approvals," a copy of the.
(6) did not obtain the "Preparation License for Medical Institutions" or "Preparation License for Medical Institutions" does not have the corresponding preparation dosage form of "hospital" category of medical institutions applying for medical institutions of traditional Chinese medicine preparations, but also should provide the following information: commissioned to dispense traditional Chinese medicine preparations of the two sides signed a commissioned dispensing contract, the preparations of preparations dispensed by the unit of the "The Preparation License for Medical Institutions" or "Preparation License for Medical Institutions". Preparation License for Medical Institutions" or "Good Manufacturing Practice" certification copy.
2, Chinese medicinal preparations must use Chinese medicine terminology for the expression of the function of the main treatment, Chinese medicine disease name.
3, Chinese medicinal preparations should be compared with the national drug standards contained in the varieties, including:
(1) prescription composition;
(2) rationale and method of characteristics;
(3) the main function.
4, information item 10 samples of the self-examination report, refers to the medical institutions to test the preparation and issued a test report. Reporting preclinical study information should be provided for three consecutive batches of samples of the self-examination report. Medical institutions that have not obtained the "Preparation License for Medical Institutions" or "Preparation License for Medical Institutions" does not have the corresponding preparation dosage form of "hospital" category of medical institutions applying for medical institutions of traditional Chinese medicine preparations, should provide the commissioned preparation unit issued by the self-inspection report on the samples of three consecutive batches of preparations.
5, according to the theory of Chinese medicine prescription, the use of traditional techniques of preparation (i.e., the preparation process does not make the original prescription of the material basis for the treatment of disease changes), and the prescription in the medical institution has more than 5 years (including 5 years) history of use of Chinese medicinal preparations can be exempted from the information items 13-17. However, if one of the following conditions need to be reported Information items 14 and 15:
(1) The composition of the prescription contains herbs that are labeled as toxic in the legal standards and are proven to be toxic in modern toxicology;
(2) The composition of the prescription contains the eighteen contraindications and nineteen contraindications in the compounding of drugs;
(3) The dosage of flavors of the prescription exceeds the provisions of the standards of the drugs.
6, the application for the preparation of chemical preparations are already the same species to obtain the approval number of preparations, can be exempted from reporting information items 13-17.
7, preclinical declaration of information items 1-16.
8, the submission of clinical research summary information, should be submitted at the same time in accordance with the review of the quality standards of three consecutive batches of self-test report.
9, the reporting information shall be printed, A4 paper, in triplicate.?
Two, the use of medical institutions to transfer preparations to declare the use of information items
1, the preparation of the transfer and transfer of both sides of the "Medical Practice License," a copy of the transfer of the party "medical institution preparation license" copy. Approved commissioned preparation of Chinese medicine preparations for medical institutions should provide the preparation preparation unit's "preparation license for medical institutions" or "Drug Production Quality Management Standard" certification copy;
2, to be transferred out of the preparation of the "medical institution preparation registration approval" copy;
3, the contract signed by both sides of the transfer;
4, the reasons for the proposed transfer of preparations, the duration, Quantity and scope;
5, quality standards, instructions and labels of the preparation to be transferred;
6, self-test report on the sample of the preparation to be transferred issued by the transferring party;
7, transferring the two sides belong to different provinces, the transferring party is responsible for the review of the provincial drug supervision and management department of the report, and must be accompanied by the opinion of the transferring party's provincial drug supervision and management department.
Three, the medical institution preparation re-registration of information items
1, supporting documents.
(1) preparation approval documents and (food) drug supervision and management department to approve the change of documents;
(2) "medical institution preparation license" copy. Approved commissioned preparation of Chinese medicine preparation for medical institutions should provide the preparation preparation unit of the "medical institutions preparation license" or "Drug Manufacturing Quality Management Standard" certification copy;
2, a summary of clinical use of preparations within three years and adverse reactions;
3, to provide the preparation of prescriptions, processes, standards;
4, the source of the raw materials used in the preparation of drugs .
D. Application forms and approval forms related to preparations for medical institutions
1. Application form for registration of preparations for medical institutions;
2. Clinical research approvals for preparations for medical institutions;
3. Approvals for registration of preparations for medical institutions;
4. Application form for transferring and using preparations for medical institutions;
5. Use of the approval.