Chapter I General Provisions
Article 1 These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law) and the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Regulations for the Implementation of the Drug Administration Law) for the purpose of strengthening the management of preparations for medical institutions and standardizing the declaration and approval of preparations for medical institutions.
Article 2 These Measures shall apply to the application for the preparation and transfer for use of preparations for medical institutions within the territory of the People's Republic of China*** and the State of China, as well as to the related approval, inspection and supervision and management.
Article 3 The preparations of medical institutions refer to the fixed prescription preparations prepared and used by medical institutions for their own use with approval according to the clinical needs of the institution.
The preparations prepared by the medical institutions, should be the market is not available varieties.
Article IV of the State Food and Drug Administration is responsible for the supervision and management of the preparation of the national medical institutions.
Provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration is responsible for the approval and supervision and management of preparations for medical institutions under its jurisdiction.
Article V. The applicant for the preparation of medical institutions shall be a medical institution that holds a Medical Institution Practice License and has obtained a Medical Institution Preparation License.
Not obtaining a "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 can apply for medical institutions of traditional Chinese medicine preparations, but must be entrusted with the preparation of the application. The unit that accepts the entrusted preparation shall be the medical institution that obtains the "Preparation License for Medical Institutions" or the pharmaceutical manufacturer that obtains the certification of "Good Manufacturing Practice". The commissioned preparation of the dosage form should be consistent with the entrusted party to hold the "preparation license for medical institutions" or "pharmaceutical production quality management standard" certificate of authentication of the scope of the same.
Article VI of the preparation of medical institutions can only be used in the medical institution with a licensed physician or physician assistant prescription, and with the "medical institutions license" contained in the scope of treatment.
Chapter II Declaration and Approval
Article 7 The application for the preparation of medical institutions should be carried out the appropriate preclinical studies, including prescription screening, preparation process, quality indicators, pharmacology, toxicology research.
Article 8 The information submitted for application for registration of preparations for medical institutions shall be true, complete and standardized.
Article 9 The chemical raw materials used in the application for the preparation and the implementation of the approval number management of Chinese herbal medicines, traditional Chinese medicine tablets must have a drug approval number, and in line with the statutory drug standards.
Article 10 The applicant shall, for the preparation for which registration is sought or for the prescription, process, use, etc., provide a description of the patent and its ownership status of the applicant or others in China; where a patent exists for another person in China, the applicant shall submit a statement that it does not constitute an infringement of the patent of the other person.
Article XI of the name of the preparation of medical institutions shall be named in accordance with the principles of drug naming promulgated by the State Food and Drug Administration, shall not use trade names.
Article XII of the medical institutions to prepare preparations for use of excipients and direct contact with the preparations of packaging materials, containers, etc., should be consistent with the State Food and Drug Administration on excipients, packaging materials in direct contact with drugs and containers, the management of the regulations.
Article XIII of the instructions and packaging labels of the preparations of medical institutions by the provinces, autonomous regions and municipalities directly under the Central Government (food) drug supervision and management department based on the information declared by the applicant, in the approval of applications for preparations together to be approved.
The instructions and packaging labels of medical institutions should be in accordance with the State Food and Drug Administration on drug instructions and packaging labels printed in accordance with the provisions of the management of the text, the pattern shall not exceed the approved content, and need to be marked with "this preparation is limited to the use of this medical institution".
Article XIV of the following circumstances, shall not be declared as a medical institution preparations:
(a) the market has been supplied with the varieties;
(b) containing the active ingredients of the varieties not approved by the State Food and Drug Administration;
(c) In addition to allergic reactions to biological products;
(d) Chinese medicine injections;
(d) the Chinese medicine injections;
(e) the Chinese medicine injections;
(f) the Chinese medicine injections. /p>
(e) Chinese medicine, chemical composition of the compound preparation;
(f) narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive drugs;
(g) other preparations that do not comply with the relevant provisions of the State.
Article 15 Application for the preparation of medical institutions, the applicant shall fill out the "application form for registration of medical institutions," to the location of the provincial, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department or its commissioned municipal (food) drug supervision and management agencies, submit the relevant information and the actual samples of preparations.
Article XVI of the application received by the provincial, autonomous regions, municipalities directly under the Central (food) Drug Administration or its commissioned municipal (food) drug supervision and management agency for the declaration of information on the form of review, in line with the requirements to be admitted; does not meet the requirements, it shall be received from the date of the application within five days of the applicant in writing and explain the reasons for the notice, the late notice of the receipt of the material from the date of acceptance. From the date of receipt of the material is accepted.
Article XVII of the provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration or its commissioned municipal (food) drug supervision and management agencies should be in the application within 10 days of acceptance of the organization's on-site inspection, take three consecutive batches of samples for testing, notification of the designated pharmaceutical testing laboratory for sample testing and technical review of quality standards. Commissioned by the municipal (food) drug supervision and management agencies shall complete the above work will be reviewed, inspection reports and reporting information to the provincial, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments, and notify the applicant.
Article XVIII received a notice of inspection of the drug testing laboratories should be completed within 40 days of sample testing and quality standards and technical review, issued a test report and standards review comments, reported to the province, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments and copy the notification of its test (food) drug supervision and management agencies and the applicant.
Article 19 Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department shall receive all the information within 40 days after the completion of the organization's technical review, in line with the provisions of the issue of "medical institutions, clinical research approvals of preparations.
Application for the preparation of chemical preparations have been the same species to obtain the approval number of preparations, can be exempted from clinical research.
Article 20 of the clinical research preparations, shall be prepared in accordance with the "medical institutions preparation preparation quality management standard" or "drug production quality management standard" requirements, the preparation shall comply with the provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department of the validation of the quality standards.
Article 21 The clinical research of the preparations of medical institutions shall be carried out in accordance with the requirements of the "Code for the Quality Management of Pharmaceutical Clinical Trials" after obtaining the "Approval for Clinical Research of Preparations for Medical Institutions", obtaining the informed consent of the subjects as well as the consent of the Ethics Committee.
Article 22 The clinical research of the preparation of medical institutions shall be conducted in accordance with the clinical research program in this medical institution, and the number of subjects shall not be less than 60 cases.
Article 23 After the completion of clinical research, the applicant to the local province, autonomous region, municipality directly under the Central Government (food) drug supervision and management department or its commissioned municipal (food) drug supervision and management agencies to submit a summary of clinical research information.
Article 24 of the provinces, autonomous regions and municipalities (food) drug supervision and management departments to receive all the declarations within 40 days after the completion of the organization's technical review, to make a decision on whether to grant permission. Comply with the provisions of the decision to grant permission shall be made within 10 days from the date of issuance to the applicant, "the medical institution preparations registered approvals" and preparation approval number, while reporting to the State Food and Drug Administration for the record; does not comply with the provisions of the applicant shall be notified in writing and explain the reasons for the applicant and inform the applicant of the right to apply for administrative reconsideration according to law, or to bring an administrative lawsuit.
Article 25 The format of the approval number of the preparation of medical institutions:
X drug H (Z) + 4 years + 4 running number.
X-province, autonomous region, municipality directly under the Central Government abbreviation, H-chemical preparations, Z-Chinese medicine preparations.
Chapter III transfer for use
Article 26 of the medical institutions preparations generally shall not be transferred for use. Disasters, epidemics, emergencies or clinical emergency and the market does not supply, the need to transfer the use of the provincial jurisdiction of medical institutions within the preparation of the transfer must be approved by the location of the provincial, autonomous regions, municipalities directly under the Central Government (food) Drug Administration; is the State Food and Drug Administration of the provisions of the special preparations, as well as provinces, autonomous regions, municipalities directly under the Central Government of the transfer of medical institutions between the preparations, it must be approved by the State Food and Drug Administration. Drug Administration approval.
Article 27 of the provincial jurisdiction to apply for medical institutions to transfer the use of preparations, should be used by the unit to the location of the provincial, autonomous regions, municipalities directly under the Central (food) drug supervision and management department to apply, explaining the reasons for the use of the period, quantity and scope, and submit the relevant information.
Provinces, autonomous regions, municipalities directly under the central medical institutions between the transfer of preparations for use, as well as the State Food and Drug Administration provides for the transfer of special preparations for use, should be approved by the preparation of the medical institutions to the location of the province, autonomous region, municipality directly under the central (food) drug supervision and management department to apply, explaining the reasons for the use of the period, quantity and scope of the province, autonomous region, municipality directly under the central (food) drug supervision and management department review and approval by the province, autonomous region, municipality directly under the central (food) drug supervision and management department. (Food) drug supervision and management department for review and approval, by the use of the unit will review the comments and related information submitted to the use of the unit's location in the provinces, autonomous regions, municipalities directly under the Central Government (Food) drug supervision and management department for review and approval, reported to the State Food and Drug Administration for approval.
Article 28 of the approved preparation number of medical institutions should be transferred to the use of medical institutions responsible for the quality of the preparation. Acceptance of the transfer of medical institutions should be strictly in accordance with the instructions for the use of preparations, and the use of the scope of use or improper use of the adverse consequences bear responsibility.
Article 29 The transfer and use of preparations of medical institutions shall not exceed the prescribed period, quantity and scope.
Chapter IV Supplementary Application and Re-registration
Article 30 The preparation of medical institutions shall be strictly enforced by the approved quality standards, and shall not change the process, prescription, preparation location and commissioned preparation unit. Need to change, the applicant shall submit a supplementary application, submit the relevant information, after approval before implementation.
Article 31 The validity of the approval number of the preparation of medical institutions for three years. The expiration of the validity of the need to continue to formulate, the applicant shall, three months before the expiration of the validity period in accordance with the original application procedures for the formulation of re-registration application, submit the relevant information.
Article 32 Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department shall accept the application for re-registration within 30 days, to make a decision on whether to approve the re-registration. Granted re-registration, the decision shall be made within 10 days from the date of notification to the applicant, to be replaced by the "medical institution preparation registration approvals", and reported to the State Food and Drug Administration for the record.
Decision not to re-register, the applicant shall be notified in writing and explain the reasons, while informing the applicant of the right to apply for administrative reconsideration according to law or the right to file an administrative lawsuit.
Article 33 of the following circumstances, the provinces, autonomous regions, municipalities directly under the Central (Food) Drug Administration shall not approve the re-registration, and cancel the approval number of the preparation:
(a) the market has been supplied with the varieties;
(b) in accordance with these measures shall be revoked the approval number of the following:
(c) failure to re-register within the prescribed time to submit applications
(d) Other non-compliance.
Article 34 The preparations of medical institutions whose approval numbers have been canceled shall not be prepared and used; if they have been prepared, they shall be destroyed or disposed of under the supervision of the local (food) drug supervision and management department.
Chapter V Supervision and Administration
Article 35 The preparation and use of preparations for medical institutions shall pay attention to the observation of adverse reactions to preparations, and in accordance with the relevant provisions of the State Food and Drug Administration to report and deal with.
Article 36 Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments of the quality of unstable, inaccurate efficacy, adverse reactions, or other reasons harmful to human health preparations, shall order medical institutions to stop preparation, and revoke its approval number.
Has been revoked the approval number of the medical institution preparations, shall not be formulated and used; has been formulated, by the local (food) drug supervision and management department to supervise the destruction or disposal.
Article 37 The sampling and testing of preparations for medical institutions, in accordance with the relevant provisions of the State Food and Drug Administration drug sampling and testing.
Article 38 of the medical institutions no longer have the qualifications or conditions of the preparation, the corresponding preparation of its own approval number abolished, and by the provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments to be canceled, but allows the commissioning of the preparation of the approval number of the preparation of traditional Chinese medicine, except. Allowed to entrust the preparation of Chinese medicinal preparations need to continue to prepare, can refer to Article 30 of this approach to change the entrusted preparation unit of the provisions of the entrusted preparation of additional applications.
Article 39 Unauthorized use of other medical institutions without approval of the preparation, in accordance with the provisions of Article 80 of the Drug Administration Law shall be punished.
Article 40 A medical institution that dispenses preparations in violation of the provisions of Articles 48 and 49 of the Drug Administration Law shall be punished in accordance with the provisions of Articles 74 and 75 of the Drug Administration Law, respectively.
Failure to formulate preparations in accordance with the standards approved by the provincial, autonomous region, municipality directly under the Central Government (food) drug supervision and management department, belonging to the "Drug Administration Law" Article 49, paragraph 3, subparagraph 6 of the other non-compliance with the provisions of the drug standard, in accordance with the provisions of Article 75 of the "Drug Administration Law" shall be punished.
Article 41 Where false supporting documents, declaration information, samples or other deceptive means are provided to apply for a certificate of approval, the provincial, autonomous region or municipality directly under the Central Government (food) Drug Administration shall not accept the application, and the applicant shall be given a warning, and the application shall not be accepted for a period of one year; where the certificate of approval has been obtained, the certificate of approval shall be revoked, and the application shall not be accepted for a period of five years, and a penalty of not less than 10,000 yuan and not more than 10,000 yuan shall be imposed. And impose a fine of 10,000 yuan or more than 30,000 yuan.
Article 42 The preparations formulated by medical institutions shall not be sold on the market or sold in disguise, and advertisements for preparations of medical institutions shall not be published.
Medical institutions shall be punished in accordance with the provisions of Article 84 of the Drug Administration Law if they sell or disguise their prepared preparations on the market.
Article 43 Provinces, autonomous regions, municipalities directly under the Central Government (food) Drug Administration in violation of the administrative behavior of these measures, the State Food and Drug Administration shall order it to make corrections within a certain period of time; overdue corrections, the State Food and Drug Administration to change or revoke.
Chapter VI Supplementary Provisions
Article 44 The administrative organ of the administrative measures to implement the administrative licensing period calculated in working days, excluding statutory holidays.
Article 45 of these Measures "fixed prescription preparations" refers to the preparation of fixed prescription, preparation process is mature, and can be clinically used for a long time in a particular disease preparation.
Article 46 Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments can be based on this approach, combined with local practice to develop implementation details.
Article 47 These Measures shall come into force on August 1, 2005 .
Attachments: 1. Requirements for the registration of preparations for medical institutions (omitted)
2. Items for the declaration of preparations for transfer and use in medical institutions (omitted)
3. Items for the declaration of preparations for re-registration in medical institutions (omitted)
4. Forms of application for preparations and approvals in medical institutions (omitted)