Procedures of the State Food and Drug Administration for Special Examination and Approval of Drugs 2005
The “Procedures of the State Food and Drug Administration for Special Examination and Approval of Drugs”, which were deliberated and adopted at the working meeting of the State Food and Drug Administration on November 18, 2005, are hereby promulgated, and shall come into force on the date of promulgation.
Procedures of the State Food and Drug Administration for Special Examination and Approval of Drugs
Chapter I General Provisions
Article 1 The present Procedures are formulated in accordance with the “Law of the People’s Republic of China on Drug Administration”, the “Law of the People’s Republic of China on Prevention and Treatment of Infectious Diseases”, the “Regulation for the Implementation of the Law of the People’s Republic of China on Drug Administration”, the “Regulation on Responding to Public Health Emergencies” and other relevant laws and regulations for the purpose of effectively preventing, timely controlling and eliminating the dangers of public health emergencies, and safeguarding the physical health and life safety of the general public.
Article 2 The procedures for special examination and approval of drugs shall refer to the procedures and requirements for special examination and approval of drugs needed in responding to the public health emergency whose threat is existing or which has occurred, which is conducted by the State Food and Drug Administration in compliance with the principles of unified command, intervention at the early stage, high efficiency and rational approval, so that the prophylaxis drugs needed in responding to the public health emergency can be approved as soon as possible.
Article 3 Where any of the following circumstances arises, the State Food and Drug Administration may legally decide to follow the present Procedures to conduct special examination and approval on the prophylaxis drugs needed in responding to a public health emergency:
(1) The president of the People’s Republic of China announces the emergent state, or the State Council decides partial areas within a province, autonomous region, or municipality directly under the Central Government to be under the emergent state;
(2) The procedures for responding to the public health emergency are started up in accordance with the law;
(3) The pharmaceutical reserve department or the health administrative department of the State Council proposes to conduct special examination and approval of drugs for which there have already been national standards;
(4) Other circumstances under which the special examination and approval is needed.
Article 4 The State Food and Drug Administration shall take charge of examining and approving clinical trials, manufacture and import, etc. of the prophylaxis drugs needed in responding to public health emergencies.
The (food) drug administrative department of a province, autonomous region, or municipality directly under the Central Government shall, upon entrustment of the State Food and Drug Administration, take charge of making on-site checks of the prophylaxis drugs needed in responding to public health emergencies, and of drawing trial samples, as well.
Chapter II Applications, Acceptance and On-site Checks
Article 5 After the procedures for special examination and approval of drugs are started, the applications for registration of prophylaxis drugs needed in responding to public health emergencies shall be uniformly accepted by the State Food and Drug Administration.
Where a drug needed in responding to a public health emergency or a preventive biological product is not sold on the domestic market, the applicant shall, before filing the application for registration, inform the State Food and Drug Administration of the relevant information on research and development thereof.
Article 6 An applicant shall, pursuant to the relevant provisions and requirements on administration of drug registration, file an application for registration to the State Food and Drug Administration, and submit the relevant technical documents.
The application for registration of a prophylaxis drug needed in responding to public health emergencies may be filed in an electronic method.
Article 7 An applicant may, before submitting an application for registration, file the application for pharmaceutical feasibility assessment first, and submit the comprehensive information and relevant explanations. The State Food and Drug Administration shall only deliberate the scientific and feasibility of project initiation of the declared pharmaceutical, and shall make a reply within 24 hours.
The reply to an application for pharmaceutical feasibility assessment shall not be deemed as the examination and approval opinions, and shall not have legal binding force to the examination and approval result of an application for registration.
Article 8 The State Food and Drug Administration shall establish a special experts’ team to evaluate and verify the application for registration of a prophylaxis drug needed in responding to public health emergencies, and shall make a decision within 24 hours on whether or not to accept the application, and meanwhile notify the applicant.
Article 9 The State Food and Drug Administration shall, after accepting an application for registration, organize the technical review of the declared information for registration within 24 hours, and meanwhile notify the (food) drug administrative department of the province, autonomous region, or municipality directly under the Central Government where the applicant is located to make an on-site check on the pharmaceutical research and manufacture information and conditions, and organize the sampling and test of the trial samples.
The (food) drug administrative department of the province, autonomous region, or municipality directly under the Central Government shall, within 5 days, submit the information on the on-site check and the relevant opinions to the State Food and Drug Administration.
Article 10 The (food) drug administrative department of a province, autonomous region, or municipality directly under the Central Government shall organize the staff from the departments of drug registration and drug safety supervision, etc. to attend the on-site check.
The National Institute for the Control of Pharmaceutical and Biological Products shall be notified to send persons to attend the on-site check and sampling of a preventive biological product.
Article 11 Where there have already been national standards for a prophylaxis drug needed in responding to public health emergencies, and the State Food and Drug Administration considers according to law that the clinical trial is unnecessary, it may directly examine and approve it in accordance with the relevant provisions in Chapter VI of the present Procedures.
Article 12 With respect to an application for registration of a special vaccine, which is filed by the applicant for modifying only the strains used in the original manufacture but not changing the manufacturing techniques or quality indices, the State Food and Drug Administration shall, within 3 days after confirming the modified strains used in the manufacture, make a decision on whether or not to grant the approval.
Chapter III Registration Inspections
Article 13 The drug inspection institution shall, after receipt of the sample drawn by the (food) drug administrative department of a province, autonomous region, or municipality directly under the Central Government, immediately organize the quality standard re-check and laboratory inspection on the sample.
The drug inspection institution shall finish the inspection work within the inspection period of the declared drug.
Article 14 For a drug under the first application for being sold on market, the State Food and Drug Administration may, when considering it necessary, appoint the National Institute for the Control of Pharmaceutical and Biological Products by way of intervention at the early stage to, prior to the registration inspection, communicate with the applicant, so as to timely resolve the technical problems which might arise in the process of quality standard re-check and laboratory inspection.
With respect to the preventive biological products used to prevent and control the epidemic situation of major infectious diseases, the State Food and Drug Administration may, when required by the situation, decide that the registration inspection shall be made simultaneously with the enterprise’s self inspection.
Article 15 After the quality standard re-check and laboratory inspection on a drug have been finished, the drug inspection institution shall issue its re-check opinions within 2 days, and submit them along with the drug inspection report to the State Food and Drug Administration.
Chapter IV Technical Review
Article 16 The State Food and Drug Administration shall, within 15 days after acceptance of the application for registration of a prophylaxis drug needed in responding to public health emergencies, finish the first round of technical review work.
Article 17 Where the State Food and Drug Administration considers that any further information needs to be supplemented, it shall immediately inform the applicant of the contents to be supplemented and the time limit for the supplement.
After the applicant submits the supplementary information within the prescribed time limit, the State Food and Drug Administration shall finish the technical review within 3 days, or may, when required by the situation, organize one more review meeting within 5 days, and finish the review report within 2 days.
Chapter V Clinical Trials
Article 18 After the technical review work is finished, the State Food and Drug Administration shall finish the administrative examination within 3 days, make a decision on whether or not to grant the approval, and inform the applicant.
Where the State Food and Drug Administration decides to issue a proof document on approval of a clinical trial, it shall issue the “Approval Document on Clinical Trial of the Pharmaceutical”; while if it decides not to approve the clinical trial, it shall issue a “Notification on the Examination and Approval Opinions”, and explain the reasons therefore.
Article 19 Where an applicant is approved to make the clinical trial of a pharmaceutical, it shall strictly follow the relevant requirements in the proof document on approval of the clinical trial to carry out the clinical trial, and strictly implement the relevant provisions in the “Good Clinical Practice”.
Article 20 The clinical trial of a pharmaceutical shall be made in an institution legally ascertained to be qualified for clinical trial of the pharmaceutical. If the clinical trial really needs to be undertaken by an institution not ascertained to be qualified for clinical trial of the pharmaceutical, it shall be specially approved by the State Food and Drug Administration.
The application for a clinical trial undertaken by an institution having not been ascertained to be qualified for clinical trial of the pharmaceutical may be filed along with the application for drug registration.
Article 21 The researchers responsible for clinical trial of a pharmaceutical shall, in accordance with the relevant provisions, timely report the adverse incident occurs in the process of the clinical trial to the State Food and Drug Administration. If no adverse incident occurs, the researchers shall gather the relevant information on a monthly basis and report it to the State Food and Drug Administration.
Article 22 The State Food and Drug Administration shall legally supervise and inspect the clinical trials of prophylaxis drugs needed in responding to public health emergencies.
Chapter VI Examination, Approval and Monitoring of Pharmaceutical Manufacture
Article 23 An applicant shall, after finishing the clinical trial of a pharmaceutical, submit the relevant information in accordance with the relevant provisions in the “Measures for the Administration of Drug Registration” to the State Food and Drug Administration.
Article 24 The State Food and Drug Administration shall, within 24 hours after receipt of the information submitted by an applicant, organize the technical review, and meanwhile notify the (food) drug administrative department of the province, autonomous region, or municipality directly under the Central Government where the applicant is located to make on-site check of the pharmaceutical manufacturing situation and conditions, and organize the drawing of and inspection on the trial sample.
The (food) drug administrative department of the province, autonomous region, or municipality directly under the Central Government shall, within 5 days, submit the information on the on-site check and the relevant opinions to the State Food and Drug Administration.
Article 25 For newly initiated drug manufacturing enterprises, newly established drug manufacturing workshops of drug manufacturing enterprises, or newly added types of preparations to be manufactured, the party concerned may apply to the State Food and Drug Administration for certification under the “Good Manufacturing Practice”. The State Food and Drug Administration shall, when making the drug registration review, immediately make an inspection on certification under the “Good Manufacturing Practice”.
Article 26 The drug inspection institution shall, after receipt of the samples of 3 successive production batch numbers as drawn by the (food) drug administrative department of the province, autonomous region, or municipality directly under the Central Government, immediately arrange for the inspection.
After the inspection work is ended, the drug inspection institution shall finish the inspection report within 2 days, and submit it to the State Food and Drug Administration.
Article 27 The State Food and Drug Administration shall carry out the technical review in accordance with Chapter IV of the present Procedures, and shall, within 3 days after the technical review, finish the administrative examination, make an examination and approval decision, and notify the applicant.
Where the State Food and Drug Administration decides to grant a proof document on approval of the drug, it shall issue the “Approval Document on Drug Registration”, and may, if the applicant meets the conditions for manufacturing the drug, meanwhile grant an approval number for the drug; while if it decides not to approve the manufacture, it shall issue a “Notification on the Examination and Approval Opinions”, and explain the reasons therefore.
Article 28 Where a pharmaceutical manufacturing or operation enterprise, or a medical and health institution finds any new or serious adverse drug reaction or group adverse reaction relevant to a specially approved prophylaxis drug needed in responding to public health emergencies, it shall immediately report to the local (food) drug administrative department of the province, autonomous region, or municipality directly under the Central Government, the health administrative department at the provincial level, and the professional institution monitoring adverse drug reactions.
The professional institution monitoring adverse drug reactions shall regard the specially approved prophylaxis drugs needed in responding to public health emergencies as the emphatically monitored varieties, analyze the collected case reports in accordance with the relevant provisions, and timely make a report to the (food) drug administrative department of the province, autonomous region, or municipality directly under the Central Government and to the State Food and Drug Administration, as well.
The State Food and Drug Administration shall strengthen the re-assessment of drugs which are manufactured upon already granted approval and needed in responding to public health emergencies after such drugs have been sold on the market.
Chapter VII Supplementary Provisions
Article 29 The measures for special examination and approval of the medical devices needed in responding to public health emergencies shall be separately formulated by the State Food and Drug Administration with reference to the relevant provisions of the present Procedures.
Article 30 The present Procedures shall come into force on the date of promulgation.
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