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The Measures for the Administration of Drug Registration have been implemented as of December 1, 2002. In order to further regulate the declaration and examination & approval of imported drugs, we hereby make the following announcement on the issues concerning the examination and approval procedures and the time limit for re-registration of imported drugs, the items concerning the supplementary application for the re-registration, and the serial number of the registration certificates: I. After accepting the re-registration applications of the following situations, this Administration shall, according to Chapter X of the Measures for the Administration of Drug Registration, complete the examination & approval for the re-registration within 100 working days, of which 40 working days shall be spent on the work of checking the original records of the drugs under applications: (1) The packaging, label and written instructions, which are modified according to the relevant provisions of this Administration for the regulation of drug packaging, label and written instructions, have been approved, and the supplementary application, which does not concern the technical evaluation, has been declared at the time when applying for the re-registration; or (2) The packaging, label and written instructions, which are modified according to the relevant provisions of this Administration for the regulation of drug packaging, label and written instructions, have been approved, and the quality standard does not need to be checked again, and no contents of the supplementary application has been declared at the same time. II. Those who file the supplementary applications for the contents prescribed in this Article, which are declared at the time when applying for the re-registration of imported drugs, shall only fill in the "Application Form for Re-registration of Drugs", and give a clear indication of the contents of the supplementary application in the column of "Other Matters Specially Declared", and the data for supplementary application shall be submitted along with the declaration data for re-registration. The examination and approval of this kind of application shall be made within the following time limit: (1) For the imported drugs, for which the following supplementary applications shall be filed at the time when applying for the re-registration, and the packaging, label and written instructions of which need to be modified according to the provisions of this Administration for the regulation of drug packaging, label and written instructions, this Administration will complete the work for the examination & approval within 140 working days, of which the time limit for the technical evaluation shall be 80 working days: 1. The alteration of contents such as the name and address of a company, the name of a manufacturing factory and the name of the drug, which do not involve the technical evaluation; 2. The additions to or improvement on the safety contents of the instructions; or 3. The shortening of the period of validity of the drug; (2) For the imported drugs, for which the following supplementary application shall be filed at the time when applying for the re-registration, and the packaging, label and written instructions of which need to be modified according to the provisions of this Administration for the regulation of drug packaging, label and written instructions, this Administration will complete the work for the examination & approval within 160 working days, of which the time limit for the technical evaluation shall be 100 working days: 1. Change of the place of production; 2. Change of the contents other than the safety contents of the drug instructions; 3. Change of the quality standard; 4. Extension of the period of validity of the drug; 5. Change of the supplementary materials or the processing techniques; or 6. Additions to the drug specifications without changing the usage, dosage or indication. III. The following supplementary applications shall not be declared with the re-registration applications together: (1) Additions to the indications; or (2) Additions to the drug specifications with the indications or usage and dosage being changed at the same time. IV. If the drugs whose packaging, label and written instructions are not in conformity with the provisions prescribed by this Administration for the regulation of drug packaging, label and written instructions, their modifications concerning the packaging, label and written instructions may be applied for beforehand when making the supplementary application, under this circumstance, the certification documents of the government need not be provided. V. The serial number of the registration certificates of imported drugs shall be made in uniform format. The uniform format for the certificate number of the "Registration Certificate of Imported Drugs" shall be: H(Z¡¢S) + year number with four digits + order number with four digits; the uniform format for the certificate number of the "Registration Certificate of Medical Products" shall be: H£¨Z¡¢S£©C+ year number with four digits + order number with four digits, of which "H" means chemical medicine, "Z" means Chinese traditional medicine, and "S" means biological product. Each registration certificate may hold only one packing specification, and the maximum packing specifications to be held shall be two. VI. The following principles shall be adhered to when compiling the number of the imported drug registration certificates for supplementary applications, with the original number of registration certificates being indicated in the remarks column of the new registration certificates. (1) For a supplementary application for additions to the specifications and packing specifications, a new registration certificate shall be issued after the application has been approved, the number of the certificate shall be compiled over again according to the time order of the approval, and the period of validity shall still be that of the original registration certificate. (2) For the registration certificates whose sub-packaging within the territory still uses the big packing specifications, a "B" shall be added to before the number of the original registration certificate, and the period of validity of which shall still be that of the original registration certificate. (3) For the supplementary applications for the change of the place of production, the name of a company or a manufacturing factory, or the name of the medicine, the original certificates shall be withdrawn and revoked after the applications have been approved, and the new registration certificates shall be issued, the certificate numbers shall be compiled over again according to the time order of the approval, and the period of validity shall still be that of the original registration certificates. (4) Other items concerning the alteration of a registration certificate shall be approved in accordance with the form of "Documents of Approval on Supplementary Applications for Drugs" all and singular. VII. If the crude drug, the central part of the preparations, and the imported sub-packaging preparations, are provided specifically for the use of internal pharmaceutical producing enterprises, the name of the production enterprise that has the right of using these drugs shall be indicated in the remarks column of the registration certificate of them according to the requirements of the applicant. VIII. For the applications for the import registration, whose summarizing report for the clinical research had been accepted before November 30, 2002, the time limit for examination & appraisal may still be in accordance with that of the supplementary data. For the applications for the import registration, whose summarizing report for the clinical research was accepted after December 1, 2002, the time limit for the examination & appraisal shall be in accordance with the requirements of the provisions of the Measures for the Administration of Drug Registration. IX. Where an applicant files a re-registration application for the imported drugs, he shall make the documents according to Attachment 5 of the Measures for the Administration of Drug Registration, and the Circular on the Declaration and Acceptance of Drug Registration (No. 240 [2002] of the State Drug Administration), and shall submit two sets of documents and three application forms, among which, at least, one set of documents and one application form shall be the original. |
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