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TABLE OF CONTENTS CHAPTER I GENERAL PROVISIONS CHAPTER II APPLICATION, EXAMINATION AND APPROVAL CHAPTER III USE THROUGH ADJUSTMENT CHAPTER IV SUPPLEMENTARY APPLICATION AND RE-REGISTRATION CHAPTER V SUPERVISION AND CONTROL CHAPTER VI SUPPLEMENTARY PROVISIONS CHAPTER I GENERAL PROVISIONS Article 1. For the purposes of intensifying the management of pharmaceutical preparations of medical institutions, regulating the application for and examination and approval of pharmaceutical preparations of medical institutions, 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 Regulation on the Implementation of the Drug Administration Law of the People's Republic of China. Article 2. These Measures shall apply to the applications for the confection and adjusted use of pharmaceutical preparations of medical institutions within the territory of the People's Republic of China as well as the relevant examination, approval, inspection, supervision and control thereof. Article 3. The term "pharmaceutical preparations of medical institutions" refers to the fixed prescription preparations that are subject to approval and are confected by medical institutions for their own use in light of the clinical needs. The pharmaceutical preparations made by medical institutions shall be those unavailable in the market. Article 4. The State Food and Drug Administration (SFDA) shall be responsible for the supervision and control of the pharmaceutical preparations of the medical institutions throughout the country. The state (food) and drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the examination, approval, supervision and control of the pharmaceutical preparations of the medical institutions within their respective jurisdiction. Article 5. The applicant of a pharmaceutical preparation of medical institution shall be a medical institution that holds a Medical Institution Practicing Permit and has obtained a Pharmaceutical Preparation Certificate for Medical institution. A "hospital" medical institution which fails to acquire a Pharmaceutical Preparation Certificate for Medical Institution or whose Pharmaceutical Preparation Certificate for Medical Institution doesn't specify the corresponding type of pharmaceutical preparation may apply for the preparation of traditional Chinese medicines of the medical institution, but it shall simultaneously file an application for the entrustment of confection of the preparation. The entity that accepts the entrustment to confect the preparation shall be a medical institution that has obtained a Pharmaceutical Preparation Certificate for Medical Institution or a drug manufacturing enterprise that has obtained an accreditation certificate of Norms for the Quality Control of Drug Manufacturing. The type of preparation confected upon entrustment shall be conform to the scope as stated in the Pharmaceutical Preparation Certificate for Medical Institution or the Norms for the Quality Control of Drug Manufacturing of the entrusted party. Article 6. The pharmaceutical preparation of a medical institution can only be used by the practicing doctors or assistant practicing doctors upon prescriptions within this medical institution and shall conform to the diagnosis and treatment scope as stated in the Medical Institution Practicing Permit. CHAPTER II APPLICATION, EXAMINATION AND APPROVAL Article 7. When applying for a pharmaceutical preparation of medical institution, the applicant shall conduct the corresponding pre-clinical study, including the screening of prescriptions, confection techniques, quality indicators, and pharmacologic and toxicological study. Article 8. The application materials submitted for the registration a pharmaceutical preparation of medical institution shall be authentic, complete and standard. Article 9. The chemical raw material medicines, which are used in the pharmaceutical preparation as applied for registration, and the traditional Chinese medicinal materials and herbal medicines for decoction, which are subject to the registered number of approval, shall have the registered number of approval of the drug and shall conform to the statutory drug standards. Article 10. For the pharmaceutical preparation applied for registration or the prescription, techniques or uses of the pharmaceutical preparation, the applicant shall provide its patent or the patent of any other person in China as well as an explanations on its ownership. If any patent of any other person exists within China, the applicant shall submit a statement of no infringement upon the patent of others. Article 11. A pharmaceutical preparation of medical institution shall be named in accordance with the principle of the SFDA on drug names rather than using any commodity name. Article 12. The supplementary materials used by a medical institution for the confection of a pharmaceutical preparation, and the packaging materials and containers that have direct contact with the pharmaceutical preparation shall be in line with the relevant provisions of the SFDA governing the supplementary materials and packaging materials and containers that have direct contact with the pharmaceutical preparation. Article 13. The specifications and packing labels of a pharmaceutical preparation shall, in light of the materials submitted by the applicant, be subject to the examination and approval of the (food) drug administration of the province, autonomous region or municipality when the pharmaceutical preparation application is approved. The specifications and packing labels of a pharmaceutical preparation of medical institution shall be printed and produced in pursuance of the provisions of the SFDA governing drug specifications and packing labels, which shall not contain any words or graphics beyond the approved scope and shall be marked by words like "The Pharmaceutical Preparation Is Limited to the Use by This Medical Institution". Article 14. No application for a pharmaceutical preparation of medical institution may be filed if the pharmaceutical preparation is under any of the following circumstances: (1) It is already available in the market; (2) It contains any active ingredients without approval of the SFDA; (3) It is a biological product with the exception of an allergen; (4) It is an injection preparation of traditional Chinese medicine; (5) It is a compound preparation that comprises traditional Chinese medicines and chemical medicines; (6) It is a narcotic, psychotropic drug, toxic drug for medical use or radioactive drug; or (7) It is a preparation of any other type that doesnĄ¯t meet the relevant provisions of the state. Article 15. When applying for the confection of a pharmaceutical preparation of medical institution, the applicant shall fill out an Application for the Registration of Pharmaceutical Preparation of Medical Institution and submit it, as well as the relevant materials and actual samples, to the (food) drug administration of the province, autonomous region or municipality directly under the Central Government where it is located, or to its authorized (food) drug administration of the districted city. Article 16. After the (food) drug administration of the province, autonomous region or municipality directly under the Central Government, or its authorized (food) drug administration of the districted city receives an application, it shall conduct a formal examination over the application materials and shall accept them if they meet the relevant requirements; if they don't meet the relevant requirements, it shall, within 5 days after it receives the application materials, give a written notice to the applicant and make an explanation; if it fails to do so, it shall be deemed to have accepted them as of the date of receipt. Article 17. The (food) drug administration of the province, autonomous region or municipality directly under the Central Government, or its authorized (food) drug administration of the districted city shall, within 10 days after it accepts an application, organize an on-the-spot inspection, shall randomly take testing samples of 3 successive batches and notify the designated institute for drug control to test the samples and conduct a technical verification of the quality standards. After the authorized (food) drug administration of the districted city finishes the above-mentioned work, it shall submit its examination opinions, inspection report and the application materials to the (food) drug administration of the province, autonomous region or municipality directly under the Central Government and shall notify the applicant of the relevant information. Article 18. The institute for drug control that receives a test notice shall, within 40 days, finish the testing of samples and technical verification of quality standards, issue a testing report and standards verification opinions, submit them to the (food) drug administration of the province, autonomous region or municipality directly under the Central Government and send a copy to the (food) drug administration that notified it to test the samples, and to the applicant as well. Article 19. The (food) drug administration of the province, autonomous region or municipality directly under the Central Government shall, within 40 days after it receives the complete set of application materials, finish the technical review. If the application meets the relevant requirements, it shall issue the applicant an Approval of Clinical Study of Pharmaceutical Preparation of Medical Institution. If, for the chemical preparation applied for confection, the applicant has obtained the registered number of preparation approval of the same type, the prepration may be exempt from clinical study. Article 20. A preparation for clinical study shall be confected in accordance with the Criterions for the Quality Control of Confection of Pharmaceutical Preparations of Medical Institutions or the Criterions for the Quality Control of Drug Manufacturing. The confected preparation shall be in line with the quality standards examined and approved by the (food) drug administration of the province, autonomous region or municipality directly under the Central Government. Article 21. After an Approval of Clinical Study of Pharmaceutical Preparation of Medical Institution has been granted and after the letter of acknowledgement and consent of the experimented persons and the permit of the ethics committee have been obtained, the clinical study of pharmaceutical preparation of medical institution shall be carried out in accordance with the requirements in the Criterions for the Quality Control of Drug Clinical Trials. Article 22. The clinical study of a pharmaceutical preparation of medical institution shall, under the clinical study scheme, be carried out within this medical institution and the number of experimented persons shall not be less than 60. Article 23. After the clinical study is finished, the application shall submit the summary materials of clinical study to the (food) drug administration of the province, autonomous region or municipality directly under the Central Government, or to its authorized (food) drug administration of the districted city. Article 24. The (food) drug administration of the province, autonomous region or municipality directly under the Central Government shall, within 40 days after it receives the complete set of application materials, finish the technical review and make a decision of approval or disapproval. If the application meets the relevant requirements, it shall issue to the applicant an Approval of the Registration of Pharmaceutical Preparation of Medical Institution as well as the registered number of the pharmaceutical preparation, and shall simultaneously report them to the SFDA for archival purposes. If the application doesn't meet the relevant requirements, it shall give a written notice to the applicant and shall make an explanation and simultaneously notify the applicant of the right to apply for administrative reconsideration or lodge an administrative lawsuit. Article 25. The format of the registered number of approval of a pharmaceutical preparation of medical institution shall be: X Pharmacists words H (Z) + 4-digit year number + 4-digit sequential number. X refers to abbreviation name of a province, autonomous region or municipality directly under the Central Government; H, chemical preparation; Z, preparation of traditional Chinese medicine. CHAPTER III USE THROUGH ADJUSTMENT Article 26. Generally speaking, a pharmaceutical preparation of medical institution shall not be used through adjustment. Where a disaster, epidemic disease or emergency occurs, or where it is badly needed for clinical use but it is unavailable in the market, if it is necessary to use the pharmaceutical preparation through adjustment and if the adjustment of this pharmaceutical preparation of medical institution is to be made within the jurisdiction at the province level, then the adjustment shall be subject to the approval of the (food) drug administration of the province, autonomous region or municipality directly under the Central Government. If the pharmaceutical preparation falls within the scope of special pharmaceutical preparations as provided for by the SFDA, or if the adjustment of pharmaceutical preparation of medical institution is to be made between different provinces, autonomous regions and municipalities directly under Central Government, the adjustment shall be subject to the approval of the SFDA. Article 27. When applying for using a pharmaceutical preparation of medical institutions through adjustment within the jurisdiction at the province level, the user shall file an application to the (food) drug administration of the province, autonomous region, municipality directly under the Central Government where it is located, shall state the reasons for use, time period, quantity and scope and submit the relevant materials thereto. If the adjustment of pharmaceutical preparation of medical institution is to be made between different provinces, autonomous regions and municipalities directly under Central Government, or if the pharmaceutical preparation falls within the scope of special pharmaceutical preparations as provided for by the state, the medical institution that holds the registered number of approval of the pharmaceutical preparation shall file an application with the (food) drug administration of the province, autonomous region or municipality directly under the Central Government where it is located and shall state the reasons for use, time period, quantity and scope. Upon examination and approval of the aforesaid (food) drug administration, the user shall submit the examination opinions and the relevant materials to the (food) drug administration of the province, autonomous region or municipality directly under the Central Government where it is located, and upon examination and approval thereof, the user shall submit the application to the SFDA for examination and approval. Article 28. The medical institution that holds the registered number of approval of pharmaceutical preparation shall be responsible for the quality of the pharmaceutical preparation to used through adjustment. The medical institution that accepts the pharmaceutical preparation through adjustment shall use it in strict compliance with the specifications thereof and shall be held liable for the bad consequences, if any, resulted from its use beyond the scope or misuse. Article 29. The use of a pharmaceutical preparation of medical institution shall not exceed the prescribed time period, quality and scope. CHAPTER IV SUPPLEMENTARY APPLICATION AND RE-REGISTRATION Article 30. When confecting a pharmaceutical preparation, the medical institution shall strictly comply with the approved quality standards, shall not illegally change the techniques, prescription, confection place or entrusted confection entity. If it is necessary to make a change, it shall file a supplementary application and submit the relevant materials, and may not make the change until it obtains an approval. Article 31. The valid period of the registered number of approval of a pharmaceutical preparation of medical institution shall be 3 years. If it is necessary to continue the confection after the expiration of the valid period thereof, the applicant shall, 3 moths prior to the date of expiration, file a re-registration application by following the original confection application procedures and submit the relevant materials. Article 32. The (food) drug administration of a province, autonomous region or municipality directly under the Central Government shall, within 30 days after it receives a re-registration application, decide to approve or disapprove the re-registration. If it approves the application, it shall notify the applicant within 10 days after it make a decision, change the Approval of the Registration of Pharmaceutical Preparation of Medical Institution of the applicant with a new one, and report it to the SDFA for archival purposes. If it decides to disapprove the re-registration, it shall give a written notice to the applicant and make an explanation, and simultaneously inform the applicant of the right to apply for administrative reconsideration or lodge an administrative lawsuit. Article 33. Under any of the following circumstances, the (food) drug administration of the province, autonomous region or municipality directly under the Central Government shall disapprove the re-registration and shall cancel the registered number of approval of the pharmaceutical preparation: (1) It is already available in the market; (2) The registered number of approval shall be revoked in accordance with these Measures; (3) No re-registration application is filed within the prescribed time limit; or (4) Other inconformity circumstances. Article 34. Where the registered number of approval of a pharmaceutical preparation of medical institution is canceled, the pharmaceutical preparation shall not be confected or used, and the already confected preparation shall be destroyed or disposed of by the local (food) drug administration. CHAPTER V SUPERVISION AND CONTROL Article 35. A medical institution that confects and uses a pharmaceutical preparation shall closely observe its adverse reactions and shall report and deal with them in accordance with the relevant provisions of the SFDA. Article 36. The (food) drug administration of each province, autonomous region or municipality directly under the Central Government shall order the medical institution to stop confecting any pharmaceutical preparation of medical institution that does harm to the health of human body for its unstable quality, unknown curative effect, serious adverse reactions or for any other reason, and shall revoke the registered number of approval of the pharmaceutical preparation. Where the registered number of approval of a pharmaceutical preparation of medical institution is revoked, the pharmaceutical preparation shall not be confected or used, and the already confected preparation shall be destroyed or disposed of by the local (food) drug administration. Article 37. The method of random testing of a pharmaceutical preparation of medical institution shall be adopted in accordance with the relevant provisions of the SDFA on random testing of drugs. Article 38. Where a medical institution loses the qualifications or conditions for confecting a pharmaceutical preparation, its corresponding registered number of approval shall be automatically invalidated and shall be canceled by the (food) drug administration of the province, autonomous region or municipality directly under the Central Government, but with the exception of a registered number of approval of a pharmaceutical preparation of traditional Chinese medicine that allows entrusted confection. If it needs to continue to confect the pharmaceutical preparation of traditional Chinese medicine that allows entrusted confection, it may file a supplementary application for entrusted confection by referring to the provisions of Article 30 of these Measures on changing the entrusted confection entity. Article 39. If a medical institution uses the pharmaceutical preparation confected by another one without approval, it shall be punished in accordance with Article 80 of the Drug Administration Law. Article 40. Where a medial institution confects a pharmaceutical preparation by any of provisions of Articles 48 and 49 of the Drug Administration Law, it shall be punished in accordance with the provisions of Articles 74 and 75. Where a medical institution fails to confect a pharmaceutical preparation according to the standards as approved by the (food) drug administration of the province, autonomous region or municipality directly under the Central Government, if the circumstance coincides with Item (6) of Paragraph 3 of Article 49 of the Drug Administration Law: "The medicine that fails to meet the prescribed standards in other respects as mentioned", the medical institution shall be punished in accordance with Article 75 of the Drug Administration Law. Article 41. Where an applicant applies for an approval or certification document by providing false certification document, application materials and samples, or by any other fraudulent means, the (food) drug administration of the province, autonomous region or municipality directly under the Central Government shall reject its application and shall give it a admonition. If the applicant has obtained the approval or certification document, the aforesaid (food) drug administration shall revoke its approval or certification document, may not accept its application within 5 years, and shall fine it 10, 000 up to 30, 000 yuan. Article 42. No medical institution may sell the pharmaceutical preparation confected by it in the market or do so in any disguised form, or release any advertisement of pharmaceutical preparation. Where a medical institution sells the pharmaceutical preparation confected by it in the market or does so in any disguised form, it shall be punished in accordance with Article 84 of the Drug Administration Law. Article 43. Where the (food) drug administration of a province, autonomous region or municipality directly under the Central Government makes an administrative act by violating these Measures, the SFDA shall order it to make corrections within a time limit; if it fails to make corrections within the time limit, the SFDA shall change or revoke the administrative act. CHAPTER VI SUPPLEMENTARY PROVISIONS Article 44. The time limits as mentioned in these Measures for the administrative organs to implement the administrative licensing shall be calculated on the basis of working days, excluding the legal holidays. Article 45. The term "fixed prescription preparations" as mentioned in these Measures refers to the pharmaceutical preparations that can be used to treat certain clinical diseases for a long term, of which the prescriptions remain unchanged and the confection techniques are mature. Article 46. The (food) drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government shall, in light of the present Measures, formulate detailed implementing rules by taking their respective circumstances into consideration. Article 47. These Measures shall be come into force as of August 1, 2005. LIST OF THE ANNEXES: (1) The Requirements for the Pharmaceutical Preparation Registration Application Materials of Medical Institutions; (2) The List of Application Materials for the Adjusted Use of Pharmaceutical Preparation of Medical Institution; (3) The List of Application Materials for the Re-registration Application of Pharmaceutical Preparation of Medical Institution; (4) The Application Forms and Approval Formats Relevant to Pharmaceutical Preparations of Medical Institutions. |
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