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Notice of the Comprehensive Department of the State Drug Administration on Doing a Good Job in the Filing of Drug Clinical Trial Institutions

Notice of the Comprehensive Department of the State Drug Administration on Doing a Good Job in the Filing of Drug Clinical Trial Institutions

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  • Time of issue:2021-07-08
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(Summary description)The Drug Administration of all provinces, autonomous regions, and municipalities directly under the Central Government, and the Drug Administration of Xinjiang Production and Construction Corps:

Notice of the Comprehensive Department of the State Drug Administration on Doing a Good Job in the Filing of Drug Clinical Trial Institutions

(Summary description)The Drug Administration of all provinces, autonomous regions, and municipalities directly under the Central Government, and the Drug Administration of Xinjiang Production and Construction Corps:

  • Categories:Company News
  • Author:
  • Origin:
  • Time of issue:2021-07-08
  • Views:0
Information

  The Drug Administration of all provinces, autonomous regions, and municipalities directly under the Central Government, and the Drug Administration of Xinjiang Production and Construction Corps:

  The "Regulations on the Administration of Drug Clinical Trial Institutions" (hereinafter referred to as the "Regulations") have been issued and will come into force on December 1, 2019. In order to do a good job in the filing of drug clinical trial institutions, the relevant matters are hereby notified as follows:

  1. Fully understand the importance of the filing of drug clinical trial institutions

  In order to implement the requirements of the "Pharmaceutical Administration Law of the People's Republic of China" (Presidential Order No. 31 of the People's Republic of China) and the Vaccine Administration Law of the People's Republic of China (Presidential Order No. 30 of the People's Republic of China), drug clinical trial institutions were adjusted from qualification accreditation to record management . This measure is conducive to the release of clinical trial resources and better meets the needs of drug research and development for drug clinical trials. It is of great significance to encourage drug innovation and promote the healthy development of the industry. The provincial drug regulatory administrations should attach great importance to the implementation of the "Regulations", strengthen supervision and guidance, and do a good job in the record management of drug clinical trial institutions within their administrative regions.

  2. Do a good job in publicity, implementation, training and record management

  The provincial drug administrations should strengthen coordination and cooperation with the health authorities at the same level, promote the publicity, implementation and training of the "Regulations", and guide the medical institutions, disease prevention and control institutions and related organizations that intend to conduct drug clinical trials within the administrative area. The unit uses the drug clinical trial institution filing management information system for filing in accordance with relevant requirements.

  Starting from December 1, 2019, relevant institutions and units can log on to the website of the National Medical Products Administration (http://www.nmpa.gov.cn) and click on "Drug and Medical Device Clinical Trial Institution Recording Management Information System ( Hereinafter referred to as the filing system)” for filing. The filing system is open to the public, and drug clinical trial sponsors can log in to the filing system to select drug clinical trial institutions that have been filed to carry out clinical trials; relevant units and individuals can log in to the filing system to inquire about drug clinical trial institution filing information.

  The filing system is organized and established by the State Drug Administration, and the daily maintenance and management work is in the charge of the Food and Drug Inspection Center of the State Drug Administration.

  3. Do a good job in the transition period

  From December 1, 2019 to November 30, 2020, drug clinical trial institutions that have been previously qualified by the national drug regulatory authority in conjunction with the national health authority shall complete the filing through the filing system, and the drug clinical trial sponsor can still continue Select corresponding drug clinical trial institutions to carry out clinical trials. Starting from December 1, 2020, sponsors should select drug clinical trial institutions that have been filed in the filing system to carry out drug clinical trials. Only medical institutions and disease control institutions that have completed the filing in the filing system can carry out clinical trials.

  4. Strengthen the supervision and inspection of drug clinical trial institutions

  All provincial drug regulatory administrations must earnestly implement their territorial regulatory responsibilities and organize daily supervision of drug clinical trial institutions. Strengthen the coordination and information communication with the health authorities at the same level; supervise and urge drug clinical trial institutions to regularly fill in annual drug clinical trial summary reports as required. Organize the formulation and implementation of the supervision and inspection plan, strengthen the supervision and inspection of drug clinical trial institutions in the administrative area; organize investigations and punishments in accordance with the Drug Administration Law, the Vaccine Administration Law and other relevant regulations for violations found.

  Regarding the situations and problems encountered during the implementation of the Regulations, attention should be paid to collection and timely communication, and major issues should be reported to the Drug Registration Management Department of the State Drug Administration in a timely manner.

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