Chapter 1 General Provisions
Article 1 The Provisions are formulated for the purpose of strengthening supervision on preparing pharmaceutical preparations in medical institutions 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 Implementation of the Drug Administration Law of the People’s Republic of China (hereinafter referred to as the Regulations for Implementation of the Drug Administration Law).
Article 2 The Provisions apply to the preparing of pharmaceutical preparations in medical institutions and supervision on the preparing.
Article 3 Supervision on the preparing of pharmaceutical preparations in medical institutions refers to supervision activities of examination, permission and inspection on the conditions and process of preparing pharmaceutical preparations in medical institutions, which are conducted by (food and) drug regulatory departments in accordance with law.
Article 4 The State Food and Drug Administration is responsible for supervision on preparing pharmaceutical preparations in medical institutions nationwide.
The (Food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for supervision on the preparing of pharmaceutical preparations in medical institutions within their respective jurisdiction.
Article 5 Medical institutions shall comply with the Good Preparing Practice for Pharmaceutical Preparations in Medical Institutions when preparing pharmaceutical preparations.

Chapter 2 Licensing of Establishment of Pharmaceutical Preparation Laboratory in Medical Institutions
Article 6 For preparing pharmaceutical preparations, a medical institution must have the staff, facilities, testing instruments, sanitary conditions and management systems to ensure the quality of pharmaceutical preparations.
Article 7 To establish a pharmaceutical preparation laboratory, a medical institution shall submit the following materials to the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government, where the medical institution is located.
(1) Application Form for Pharmaceutical Preparation Certificate for Medical Institution (see appendix 1);
(2) Report on conducting self-testing in line with the Good Preparing Practice for Pharmaceutical Preparations in Medical Institutions;
(3) General information about the medical institution and photocopies of the duplicate of the Practicing License of Medical Institution;
(4) Consent of the local health administrative department of the province, autonomous region or municipality directly under the Central Government;
(5) General information about the pharmaceutical preparation laboratory to be established, including conditions such as the investment size, area, surrounding environment and infrastructure of the pharmaceutical preparation laboratory, master plan of the medical institution and master plan of the pharmaceutical preparation laboratory (air cleanliness class shall be marked);
Resumes of the person in charge of the pharmaceutical preparation laboratory, person in charge of the testing laboratory and person in charge of organizing quality management for pharmaceutical preparations (including their name, age, sex, academic qualification, major, position, professional title and number of years of work experience in medicine) and the proportion of technical personnel to the staff of the pharmaceutical preparation work;
The person in charge of the pharmaceutical preparation laboratory, person in charge of the testing laboratory and person in charge of organizing quality management for pharmaceutical preparations shall be on-the-job professionals of the institution, and the person in charge of the pharmaceutical preparation laboratory and the person in charge of the testing laboratory may not be the same one concurrently.
(6) Dosage forms to be formulated, preparation capability, variety and specification;
(7) Process flow chart and quality specifications (or draft) of the dosage form (to be) formulated;
(8) List of main preparation equipment and testing instruments;
(9) List of preparation management and quality management documents.
Article 8 The applicant shall be responsible for the authenticity of the application dossier.
Article 9 After the application is received, the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall handle the application respectively according to the following circumstances:
(1) Where an application item is not subject to the jurisdiction of the concerned department by law，the department shall immediately decide not to accept the application and inform the applicant to file the application with relevant administrative authorities;
(2) Where in the dossier there is an error that can be corrected on-site, on-site correction by the applicant shall be allowed;
(3) Where the dossier is incomplete or not conformed with the requirements of preliminary review，the applicant shall be given an one-off Notice for Supplementary Data or Correction, specifying all contents to be added or corrected, on site or within five days. If the applicant is not informed within the timeline, the application is regarded as accepted on the date the dossier is received.
(4) If the application dossier is complete and in compliance with the requirements of preliminary review or the applicant has submitted all the required supplementary or corrected data, the application of drug registration shall be accepted.
Where the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government accepts or rejects the application for Pharmaceutical Preparation Certificate for Medical Institution, it shall issue a dated Acceptance Notice or Non-Acceptance Notice with its seal for acceptance.
Article 10 The (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days from the date the application is received, organize acceptance inspection according to the Acceptance Standard for Pharmaceutical Preparation Certificate for Medical Institution formulated by the State Food and Drug Administration. If the application passes the acceptance inspection, the department shall approve it and issue the Pharmaceutical Preparation Certificate for Medical Institution to the applicant within 10 working days from the date the approval decision is made; if the application fails the acceptance inspection, the department shall make a disapproval decision, notify the applicant in writing with the reasons thereof, and inform the applicant of the right to apply for administrative reconsideration or to bring an administrative suit by law.
For the application passing the acceptance inspection, the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall, within 20 working days from the date the Pharmaceutical Preparation Certificate for Medical Institution is granted, submit relevant information to the State Food and Drug Administration for the record.
Article 11 The (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall publicize at the workplace the items, basis, conditions and timeline for application for the Pharmaceutical Preparation Certificate for Medical Institution, list of all the data needed to be submitted and model text of the application form.
The (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall give publicity to the decision of issuing the Pharmaceutical Preparation Certificate for Medical Institution , which the general public is entitled to consult
Article 12 When examining the application for establishment of a pharmaceutical preparation laboratory in a medical institution, the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall publicize the process and result of examination and approval. For items directly involving their vital interests, the applicant and interested party may submit written opinions to present their cases and argues.
Article 13 If the application for establishment of a pharmaceutical preparation workshop in a medical institution directly involves the vital interests of the applicant and others, the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall advise the applicant and interested party of their right to apply for a hearing.
In the process of issuing the Pharmaceutical Preparation Certificate for Medical Institution, where there is any permitting matter which the State Food and Drug Administration and the (food and) drug regulatory department of the province, autonomous region and municipality directly under the Central Government deems as vital importance and involving public interests, the matter shall be made known to the general public, and a hearing shall be held.
Article 14 A medical institution shall not share preparation site, equipment and testing facilities with any other organization(s).
Chapter 3 Management of the Pharmaceutical Preparation Certificate for Medical Institution
Article 15 The Pharmaceutical Preparation Certificate for Medical Institution is available as the original and a duplicate. Both the original and the duplicate have the same legal effect and a validity period of five years.
Format of the Pharmaceutical Preparation Certificate for Medical Institution is uniformly prescribed by the State Food and Drug Administration.
Article 16 The Pharmaceutical Preparation Certificate for Medical Institution is a legal document for a medical institution to prepare pharmaceutical preparation and shall include items such as the certificate number, name of the medical institution, type of the medical institution, name of legal representative, name of person in charge of the pharmaceutical preparation laboratory, preparation scope, registered address, address of preparation site, issuing authority, date of issuance and validity period, of which, items to be examined and approved by (food and) drug regulatory departments include the name of the person in charge of the pharmaceutical preparation workshop, address of preparation site, preparation scope and validity period. The certificate number and preparation scope shall be filled in according to the numbering method and type of the pharmaceutical preparation prescribed by the State Food and Drug Administration (see Appendix 2 and Appendix 3).
Article 17 Change of the Pharmaceutical Preparation Certificate for Medical Institution is divided into change of approved items and change of registered items.
Change of approved items means change of the person in charge of the pharmaceutical preparation laboratory, address of preparation site and preparation scope.
Change of registered items means change of items such as the name of the medical institution, type of the medical institution, name of legal representative and registered address.
Article 18 Any medical institution that intends to change the approved items in the Pharmaceutical Preparation Certificate for Medical Institution shall, at least 30 days prior to change of any approved items, apply to the original examination and approval authorities for registration of change. The original certificate-issuing authority shall decide whether to approve the change within 15 days from the date it receives the application.
Any medical institution that intends to extend the preparation scope or change the address of preparation site shall submit relevant materials prescribed in Article 7 of the Provisions. It shall handle the registration of change to the Pharmaceutical Preparation Certificate for Medical Institution in accordance with the first paragraph of this article after passing the acceptance inspection by the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government
Article 19 Any medical institution that intends to change registered items shall apply for registration of change to the Pharmaceutical Preparation Certificate for Medical Institution to the original issuing authority within 30 days after relevant authorities approved the change. The original issuing authority shall handle the change within 15 working days from the date the application for change is received.
Article 20 After the change of the Pharmaceutical Preparation Certificate for Medical Institution, the original issuing authority shall record the changed content and time of change on the duplicate of the Pharmaceutical Preparation Certificate for Medical Institution, reissue a Pharmaceutical Preparation Certificate for Medical Institution with the changed items and withdraw the previous Pharmaceutical Preparation Certificate for Medical Institution.
Article 21 To continue preparing pharmaceutical preparations upon expiration of the validity period of the Pharmaceutical Preparation Certificate for Medical Institution, a medical institution shall, at least six months prior to expiration of the validity period, apply for renewal of the Pharmaceutical Preparation Certificate for Medical Institution to the original issuing authority.
The original issuing authority shall, in view of the medical institution’s performance in complying with relevant laws and regulations, the Good Preparation Practice for Pharmaceutical preparation in Medical Institutions and operation of the quality system, conduct examination in accordance with the conditions and procedures concerning establishment of pharmaceutical preparation laboratory in medical institutions in the Provisions, and decide whether to approve the renewal of the Pharmaceutical Preparation Certificate for Medical Institution upon expiration. For an application in conformity with relevant provisions, the issuing authority shall withdraw the original certificate and issue a new one; for an application not in conformity with relevant provisions, the issuing authority shall make a decision of disapproving the change of the certificate in writing with the reasons thereof, and inform the applicant of the right to apply for administrative reconsideration or to bring an administrative suit by law. If no decision is made within the time limit, the issuing authority shall be considered as approving the change of the certificate and complete relevant procedures.
Article 22 Where a medical institution stops preparing pharmaceutical preparation or is closed, the original issuing authority shall take back the Pharmaceutical Preparation Certificate for Medical Institution for cancellation and report to the State Food and Drug Administration for the record.
Article 23 Where a Pharmaceutical Preparation Certificate for Medical Institution is lost, the certificate holder shall publish a declaration of loss in the media designated by the original issuing authority and apply for reissuing the certificate to the original issuing authority. The original issuing authority shall reissue the Pharmaceutical Preparation Certificate for Medical Institution within 10 working days after the declaration of loss has been published for one month.
Article 24 Where the person in charge of testing laboratory or the person in charge of organizing quality management in a pharmaceutical preparation laboratory of a medical institution is changed, relevant materials including resume and academic certification of the person concerned shall be sent to the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government for the record within 30 days from the date of change.
Article 25 Where the conditions such as key preparation facilities of a pharmaceutical preparation laboratory are changed, the change shall be reported to the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government for the record within 30 days from the date of change. The (food and) drug regulatory department shall carry out an inspection as needed.
Article 26 The (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall collect and report matters concerning issue, change, renewal, cancellation and reissue of the Pharmaceutical Preparation Certificate for Medical Institution in the previous year to the State Food and Drug Administration before the end of March each year.
Article 27 No organization or individual may forge, tamper with, merchandise, rent or lend out the Pharmaceutical Preparation Certificate for Medical Institution.

Chapter 4 Administration of Contract Preparing of
Traditional Chinese Medicine Preparations of“Hospital”-type Medical Institutions
Article 28 While approved by the (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government, a “Hospital”-type medical institution that has obtained a Pharmaceutical Preparation Certificate for Medical Institution and a pharmaceutical preparation approval number for a traditional Chinese medicine preparation may entrust a medical institution with a Pharmaceutical Preparation Certificate for Medical Institution or a drug manufacturer with a certificate of Good Manufacturing Practice for Pharmaceutical Products in the province, autonomous region or municipality directly under the Central Government to prepare the traditional Chinese medicine preparation. The dosage form of the preparation for contract preparing shall be consistent with what is specified in the Pharmaceutical Preparation Certificate for Medical Institution or the certificate of Good Manufacturing Practice for Pharmaceutical Products held by the entrustee.
A “hospital”-type medical institution without a Pharmaceutical Preparation Certificate for Medical Institution shall follow relevant requirements of the Provisions for Registration of Pharmaceutical Preparations in Medical Institutions when applying for contract preparing in its application for approval number of a traditional Chinese medicine preparation.
Article 29 The entrustor shall submit application dossier for contract preparing of a traditional Chinese medicine preparation to the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government in accordance with Article 33 of the Provisions. The (food and) drug regulatory department shall accept the application in accordance with Article 9 of the Provisions.
Article 30 The (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall examine the application in accordance with conditions prescribed in this chapter and make a decision within 20 working days from the date the application is accepted.
For an application in conformity with relevant provisions, the department shall approve and issue an Approval for Contract Preparing of Traditional Chinese Medicine Preparation of Medical Institution within 10 working days upon the written decision of approval; for an application not in conformity with relevant provisions, the department shall inform the entrustor in writing of the decision with the reasons thereof and the entrustor’s right to apply for administrative reconsideration or to bring an administrative suit by law.
Article 31 The validity period of the Approval for Contract Preparing of Traditional Chinese Medicine Preparation of Medical Institution shall not exceed the validity period recorded in approval document of the preparation. The entrustor shall not entrust another institution to prepare the preparation within the validity period of the Approval for Contract Preparing of Traditional Chinese Medicine Preparation of Medical Institution.
Article 32 Where an entrustor needs to continue contract preparing upon expiration of the Approval for Contract Preparing of Traditional Chinese Medicine Preparation of Medical Institution, it shall, 30 days prior to expiration, go through the renewal procedures of contract preparing.
The Approval for Contract Preparing of Traditional Chinese Medicine Preparation of Medical Institution is annulled automatically upon termination of the contract of preparation.
Article 33 The following materials shall be provided for an application for contract preparing:
(1) Application Form for Contract Preparing of Traditional Chinese Medicine Preparation of Medical Institution (see Appendix 4);
(2) Pharmaceutical Preparation Certificate for Medical Institution of the entrustor and a photocopy of the approval document of the pharmaceutical preparation;
(3) Photocopies of the Drug Manufacturing Certificate, certificate of Good Manufacturing Practice for Pharmaceutical Products or Pharmaceutical Preparation Certificate for Medical Institution of the entrustee;
(4) Quality specifications and preparing techniques of the contracted preparation;
(5) Samples of the original minimum package, label and insert sheet of the contracted preparation;
(6) Style and color mark of the package, label and insert sheet to be used for the contracted preparation;
(7) Contract of preparation;
(8) Opinions of the (food and) drug regulatory department in the city consisting of districts, where the entrustee is located, concerning the entrustee’s production conditions and capacity, including technical personnel, plant (preparation laboratory), facilities and equipment as well as its quality assurance systems, including quality testing division and testing equipment.
The following materials shall be provided when applying for renewal of contract preparing.
(1) Photocopies of the Pharmaceutical Preparation Certificate for Medical Institution of the entrustor and the approval document of the preparation;

(2) Photocopies of the Drug Manufacturing Certificate, certificate of Good Manufacturing Practice for Pharmaceutical Products or Pharmaceutical Preparation Certificate for Medical Institution of the entrustor;
(3) The Approval for Contract Preparing of Traditional Chinese Medicine Preparation of Medical Institution approved previously;
(4) Summary of the preparing process and quality of the preparation during the period of the previous contract;
(5) Proof document of change to the previous Approval for Contract Preparing of Traditional Chinese Medicine Preparation of Medical Institution.
Article 34 The original specifications approved shall be implemented for the contracted preparation. Its formulation, process, packaging specification, label and insert sheet shall be identical with those originally approved. Names of the entrustor and entrustee and production site of the entrustee shall be marked on the package, label and insert sheet of the contracted preparation.
After the Approval for Contract Preparing of Traditional Chinese Medicine Preparation of Medical Institution is obtained, the entrustor shall submit the first three batches of the preparation to a local drug testing institute abov municipal level in a city consisting of districts, and shall only put the preparation into use after tested as qualified.
Article 35 The entrustor is responsible for the quality of the contracted preparation; the entrustee shall have the proper conditions for preparing the contracted preparation and quality assurance, conduct preparation in accordance with the Good Manufacturing Practice for Pharmaceutical Products or Good Preparation Practice for Pharmaceutical Preparations of Medical Institutions, issue the batch test report to the entrustor and keep all the documents and records relating to the contract preparing as required.
Article 36 The (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall refer to and implement relevant requirements in Article 11 to Article 13 of the Provisions when examining the application for contract preparing.
Article 37 The (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall report to the State Food and Drug Administration matters relating to their approvals on contract preparing of the preparation.

Chapter 5 Supervision and Inspection
Article 38 “Supervision and inspection” specified in the Provisions mainly refers to on-site inspection and routine supervision and inspection in terms of medical institutions’ implementation of the Good Preparing Practice for Pharmaceutical Preparations of Medical Institutions and renewal of the Pharmaceutical Preparation Certificate for Medical Institution.
Article 39 The (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for supervision and inspection on preparing pharmaceutical preparations of medical institutions within their respective jurisdiction, and shall establish and implement an operation mechanism and management system for supervision and inspection, and define the supervision and inspection responsibilities of the municipal (food and) drug regulatory departments in cities with districts and county-level (food and) drug regulatory departments.
The State Food and Drug Administration may organize supervision and inspection on preparing pharmaceutical preparations of medical institutions as needed ; meanwhile, it shall supervise and randomly check the supervision and inspection of the (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government.
Article 40 When organizing supervision and inspection, the (food and) drug regulatory departments at various levels shall draft an inspection plan, specify an inspection standard, faithfully record information about the on-site inspection, propose items to be rectified and a time limit for rectification, inform the inspected organization of the result in writing and carry out follow-up inspections.
Article 41 A medical institution shall provide relevant information and materials at the time of supervision and inspection.
(1) Information about implementation of self-examination in line with the Good Preparing Practice for Pharmaceutical Preparations in Medical Institutions;
(2) Practicing License of Medical Institution and Pharmaceutical Preparation Certificate for Medical Institution;
(3) Information about change of the person in charge of the drug testing laboratory, person in charge of organizing quality management as well as main preparation conditions and equipment.
(4) Information about supervision and inspection on the pharmaceutical preparation laboratory and its implementation of rectification;
(5) Information about rectification of substandard pharmaceutical preparations published on the quality announcement;
(6) Other materials needed to be examined.
Article 42 After completing supervision and inspection, the (food and) drug regulatory department shall indicate the inspection data on the duplicate/second sheet of the Pharmaceutical Preparation Certificate for Medical Institution and include the following items：
(1) Conclusion of the inspection;
(2) Whether there is any serious quality accident in association with the pharmaceutical preparation; whether there is any substandard pharmaceutical preparation announced on the pharmaceutical quality bulletin.
(3) Whether the pharmaceutical preparation laboratory has committed any illegal act of preparation, and information about investigation and handling;
(4) Whether the pharmaceutical preparation laboratory has prepared any pharmaceutical preparation the same year.
Article 43 Where there is any serious quality accident in association with the pharmaceutical preparation, the medical institution concerned must immediately report the accident to the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government and relevant departments. The (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall report the accident to the State Food and Drug Administration within 24 hours.
Article 44 No (food and) drug regulatory department shall interfere with the normal preparing activities of medical institutions, ask for or accept money or things of value from medical institutions or seek other benefits during supervision and inspection.
Article 45 Any organization or individual who finds that a medical institution is engaged in activities of illegal preparation has the right to report the offence to (food and) drug regulatory departments. The (food and) drug regulatory department receiving the report shall verify and handle the case promptly.
Article 46 For any of the circumstances described in Article 70 of the Administrative Permission Law of the People’s Republic of China (hereinafter referred to as the Administrative Permission Law), the original issuing authority shall cancel the Pharmaceutical Preparation Certificate for Medical Institution in accordance with law.
In cases of canceling a Pharmaceutical Preparation Certificate for Medical Institution, the (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall notify relevant departments and report to the State Food and Drug Administration for the record within five days from the date of cancellation.
Chapter 6 Legal Liabilities
Article 47 In any of the circumstances described in Article 69 of the Administrative Permission Law, the State Food and Drug Administration or the (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government may withdraw the Pharmaceutical Preparation Certificate for Medical Institution at the request of the interested party or according to its responsibilities and authorities.
Article 48 Where an applicant conceals relevant information or provides false application dossier for the Pharmaceutical Preparation Certificate for Medical Institution, the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall refuse to accept or disapprove the application, and give a warning to the applicant. The applicant shall not be allowed to file an application again within 1 year.
Where an applicant has obtained a Pharmaceutical Preparation Certificate for Medical Institution by providing false materials, the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall revoke its Pharmaceutical Preparation Certificate for Medical Institution and impose a fine of no less than RMB10,000 yuan but no more than RMB 30,000 yuan. The applicant shall not be allowed to file an application again within 5 years.
Article 49 A medical institution preparing a pharmaceutical preparation without the Pharmaceutical Preparation Certificate for Medical Institution shall be punished in accordance with the provisions in Article 73 of the Drug Administration Law.
Article 50 Where a (food and) drug regulatory department issues a Pharmaceutical Preparation Certificate for Medical Institution to an institution that is not in compliance with the statutory requirements, punishment shall be imposed in accordance with the provisions in Article 94 of the Drug Administration Law.
Article 51 In cases of contract preparing of a pharmaceutical preparations or accepting the a contract preparing without approval, both the entrustor and entrustee shall be punished in accordance with the provisions in Article 74 of the Drug Administration Law.
Article 52 Any medical institution that violates Article 19 and Article 24 of the Provisions shall be ordered to make corrections by the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government.
Any medical institution that violates Article 25 of the Provisions shall be warned and ordered by the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government to make corrections within a time limit; those who fail to make corrections within the time limit shall be liable to a fine of no less than RMB5,000 Yuan and no more than RMB 10,000 Yuan.
Article 53 Anyone who violates relevant laws and regulations while implementing an administrative permission stipulated by the Provisions shall be punished in accordance with relevant laws and regulations.
Chapter 7 Supplementary Provisions
Article 54 The State Food and Drug Administration is responsible for the interpretation of the Provisions.
Article 55 The Provisions shall go into effect as of June 1, 2005.

Appendix 1: