The State Food And Drug Administration Drug Approval Process

Original Language Title: 国家食品药品监督管理局药品特别审批程序

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(November 18, 2005 national food drug supervision authority makes 21st, announced since announced of day up purposes) first chapter General first article for effective prevention, and timely control and elimination burst public health event of against, guarantees public body health and life security, according to People's Republic of China drug management method, and People's Republic of China infectious diseases control method, and People's Republic of China drug management method implementation Ordinance and burst public health event Emergency Ordinance, legal, and regulations provides, developed this program.
    Second article drug special approval program is refers to, exists occurred burst public health event of threat Shi and burst public health event occurred Hou, for makes burst public health event emergency by needed control drug as soon as possible get approved, national food drug supervision authority according to unified command, and early intervention, and fast efficient, and science approval of principles, on burst public health event emergency processing by needed drug for special approval of program and requirements.
    Article when the following conditions exist, may, in accordance with the State food and Drug Administration decided in accordance with the procedures on public health emergency prevention drugs for special approval: (a) the People's Republic of China President to declare a State of emergency or the State Council decided to provinces, autonomous regions and municipalities when a State of emergency in some areas within the scope of, (ii) public health emergency handling startup programs;
    (C) the drug reserves Department of health Administrative Department in charge of the national standards and drug approval of special proposals and (iv) other circumstances that require special approval.
    Fourth the State food and Drug Administration is in charge of control required for emergency of public health emergency medicine clinical drug trials, production and import matters for approval.
    Provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and administrative departments authorized by the State food and drug administration, responsible for combating drugs required for emergency of public health emergency on-site verification trial samples and sampling.
    Chapter II application processing and field verification started the fifth special drug approval process, required for emergency response to sudden public health incidents prevention drug registration from the State food and Drug Administration is responsible for handling.
    Required for emergency of public health emergency medicine and preventive biological products are not sold in the domestic market, the applicant shall, before his application for registration, on the situation notified the State food and drug administration research and development.
    Article the applicant shall in accordance with the relevant provisions of drug registration and requirements, to the State food and Drug Administration to submit applications for registration, and submit the technical information.
    Emergency response to sudden public health incidents required e-filing an application for registration made to combat drugs. Article before you submit your application for registration of the applicant may initially submit a feasibility evaluation of drug application, and submit the summary information and instructions.
    The State food and Drug Administration to declare the drug only to establish the project's scientific and feasibility evaluation, and give a reply within 24 hours.
    Responses were not as approval for a drug evaluation application, an application for registration of the outcome is not legally binding.
    Eighth State food and Drug Administration to establish a special group of experts on public health emergency prevention drug registration applications required assessments and audits, and to make admissibility decisions within 24 hours, notify the applicant.
    Nineth after accepting an application for registration, the State food and drug administration shall organize the registration documents are in the 24-hour technical review, and notify the applicant location of provinces, autonomous regions and municipalities directly under the (food) on drug development and drug regulatory conditions for on-site verification, sampling, inspection and organize the trial samples.
    Provinces, autonomous regions and municipalities (food) pharmaceutical supervisory and administrative departments shall, in the 5th spot verification and related observations reported to the State food and drug administration.
    Tenth of provinces, autonomous regions and municipalities (food) pharmaceutical supervisory and administrative departments shall organize drug registration, drug safety department personnel to participate in on-site verification.
    Preventive biological products for on-site verification and sampling should be notified of pharmaceutical and biological products are attended.
    11th sudden public health accidents prevention drugs have required standards, the State food and drug administration in accordance with law does not consider the need for clinical trials of drugs, directly in accordance with the relevant provisions of the sixth chapter of this program for approval.
    12th for the applicant to submit changes only original production virus strain without changing the production process and quality indicators for specific vaccine applications for registration of alternation shall be confirmed by the State food and Drug Administration make an approval decision within 3rd after the virus strains used for production.
    Received chapter III examination article 13th to inspect bodies of provinces, autonomous regions and municipalities directly under the (food) after taking the drug regulatory agency of samples, quality standards shall immediately organize the sample reviews and laboratory testing.
    Drug inspection bodies shall perform inspection in accordance with Declaration of drug testing cycle.
    Article 14th listing drugs for the first time, the State food and Drug Administration considers it necessary, early intervention can be taken, prior to assignment of pharmaceutical and biological products which registered communicating with applicants, solve the quality standards for reviews and laboratory testing of technical issues that may arise in the process.
    For the prevention and control of major infectious diseases preventive biological products, according to the State food and Drug Administration needs, you can decide to register test synchronized with enterprise self test.
    15th drug quality standards of review and completion of lab tests, drug testing agencies should review opinions issued by the 2nd, together with the pharmaceutical inspection report be submitted to the State food and drug administration.
    Technical review of the fourth chapter 16th State food and drug administration required to receive public health emergency prevention and drug registration application, should be completed in the 15th round of the technical review process.
    17th the State food and drug administration requires additional information, additional information should be the content and time requirements to inform the applicant immediately.
    The applicant submitted additional information within the prescribed time limit, State food and Drug Administration should be completed in the 3rd technical review, or organized again in the 5th meeting to review as needed, and finished in 2nd review report.
    Fifth chapter article 18th after the completion of the technical review process of clinical trials, the State food and Drug Administration should be completed in the 3rd administrative reviews, according to the decision, and inform the applicant.
    State food and Drug Administration decision to grant approval documents for clinical trials, drug clinical trial approval shall issue decided not to approve clinical trials, the approval notice should be sent, together with the reasons.
    Article 19th applicant for drug clinical trials, clinical trial approval documents shall be in strict accordance with the relevant requirements of carrying out clinical tests and strict implementation of the relevant provisions of the code for quality management of drug clinical trials. Drug clinical trial should be in the article 20th identified by institutions with qualified clinical drug trial.
    Clinical trials required by the adopted drug clinical trials accreditation agency, must receive special approval from the State food and drug administration.
    Without the accreditation of drug clinical trials Agency applications for clinical trials and drug registration application made.
    21st drug clinical trial researchers should be responsible for the clinical trial process in a timely manner in accordance with the relevant provisions in the occurrence of adverse events reported to the State food and drug administration; no adverse event occurred, should report the monthly summary of the situation.
    22nd State in accordance with the food and drug administration required for emergency prevention of public health emergency medicine clinical drug trials carry out supervision and inspection.
    Sixth chapter of drug production, approval and monitoring article 23rd after clinical trials have been completed the applicant, in accordance with the relevant provisions of the administrative measures for the registration of pharmaceuticals and related information submitted to the State food and drug administration.
    24th State food and drug administration after receipt of the information submitted by the applicant, shall organize technical reviews within 24 hours, notify the applicant location of provinces, autonomous regions and municipalities directly under the (food) conditions of drug supervision and administration of drug production and on-site verification, sampling, inspection and organize the trial samples.
    Provinces, autonomous regions and municipalities (food) pharmaceutical supervisory and administrative departments shall, in the 5th spot verification and related observations reported to the State food and drug administration. 25th new drug manufacturer, pharmaceutical production enterprises of new pharmaceutical production plant or released production forms, can be applied to the State food and Drug Administration good manufacturing practices certification.
    State food and Drug Administration drug registration review should at the same time, immediate certification of good manufacturing practices inspections.
    Article 26th drug inspection agencies received from provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and Administrative Department of the 3 after a batch of samples shall immediately organize the inspection.
    Inspection after the drug Inspection Agency inspection reports should be completed in the 2nd, and submitted to the State food and drug administration.
    27th the State food and Drug Administration should be carried out in accordance with the provisions of this program, the fourth chapter technical review and completion of the technical review process completed 3rd administrative reviews, according to the decision, and inform the applicant.
    The State food and Drug Administration decision to grant drug approval documents shall be issued by the drug registration documents, applicants with drug production, and drug approval numbers; decides not to approve the production of, the approval notice should be sent, together with the reasons. 28th of drug production, trading enterprises and medical organizations found approval with sudden public health accidents relating to combating drugs required a new adverse reaction or serious adverse drug reactions, groups, should be immediately to the local provinces, autonomous regions and municipalities directly under the (food) pharmaceutical supervisory and administrative departments, provincial health administrative departments and the specialized agency for monitoring of adverse drug reaction reports.

    Adverse drug reaction surveillance professional institutions of special authorization should be required for emergency prevention and control of public health emergencies focus on drug monitoring, in accordance with the relevant provisions for the collection of case reports to summarize and analyze, and timely reporting of the provinces, autonomous regions and municipalities directly under the (food) the pharmaceutical supervisory and administrative departments and the State food and drug administration.
    Should strengthen the State food and Drug Administration has approved the production of public health emergency listing of the medicines needed after evaluation.
    Seventh chapter supplementary articles article 29th public health emergency required special approval of medical devices, by the State food and drug administration, reference to the relevant provisions of this program separately. 30th article of the program come into effect as of the date.

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