National Policy for the Cellular Gene Industry (as of September 2023)
Release Date:2023-10-16

Source: Realistic Medicine Society

In order to better support the scale and standardized development of the cell and gene therapy industry, the state and various provinces and cities have introduced policies to support it in 2023. Today, we take stock of the relevant policies and regulations for the development of cell and gene therapy in China in the first half of 2023.

CDE releases "Technical Guidelines for Pharmaceutical Research and Evaluation of Oncolytic Virus Products (Trial)"

2On February 13, 2023, the Center for Drug Examination and Approval (CDE) of the State Drug Administration issued: In order to regulate and guide the pharmaceutical research, production and registration of oncolytic virus products, under the deployment of the State Drug Administration, the Center for Drug Examination and Approval organized the formulation of the Technical Guidelines for Pharmaceutical Research and Evaluation of oncolytic virus Products (Trial). In accordance with the requirements of the Notice of the General Department of the State Drug Administration on the Release procedure of the Technical Guidelines for Printing and Distributing Drugs (Comprehensive Drug Administration 2020) No. 9), the State Drug Administration has reviewed and agreed to issue this document, and it will come into force as of the date of release.

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The central government issued a New Deal to support the development of cutting-edge medical technologies such as stem cell and regenerative medicine, new vaccines, biotherapy, and precision medicine

On March 23, 2023, the General Office of the CPC Central Committee and The General Office of the State Council issued the Opinions on Further Improving the Medical and Health Service System (hereinafter referred to as the Opinions), and issued a notice requiring all regions and departments to conscientiously implement it in light of the actual situation. Among them, the "Opinions" proposed to strengthen the research and development system and capacity building of clinical medicine, public health and medical devices, and develop cutting-edge medical technologies such as omics technology, stem cell and regenerative medicine, new vaccines, biotherapy, and precision medicine.

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CDE issued the "Drug Examination Center to accelerate the Evaluation of Innovative Drug Marketing Authorization Application work Specification (Trial)"

On March 31, 2023, the Center for Drug Administration (CDE) issued: In order to further encourage innovation, the Center for Drug Administration organized the formulation of the Work Specification for Accelerating the Evaluation of Innovative drug Marketing Authorization Applications (Trial), which was reviewed and approved by the State Drug Administration and is now issued and implemented from the date of release.

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The Ministry of Science and Technology issued the draft Measures for the Review of Ethics in Science and Technology (Trial) for soliciting comments

On April 4, 2023, the Ministry of Science and Technology issued: In order to implement the Opinions on Strengthening the Ethical Governance of Science and Technology, strengthen the ethical review and supervision of science and technology, and promote responsible innovation, the Ministry of Science and Technology, led by the relevant departments, studied and drafted the "Measures for the Ethical Review of Science and Technology (Trial)", which is now open to the public for comments.

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CDE issued the Technical Guidelines for the Design of Clinical trials for Gene Therapy Hemophilia

On April 14, 2023, the Center for Drug Evaluation (CDE) of the State Food and Drug Administration issued: In order to guide the design of clinical trials for gene therapy hemophilia, the Center for Drug Evaluation organized the formulation of the Technical Guidelines for clinical Trial Design for gene therapy Hemophilia. In accordance with the requirements of the Notice of the General Department of the State Drug Administration on the Release procedure of the Technical Guidelines for Printing and Distributing Drugs (Comprehensive Drug Administration of the State Drug Administration (2020) No. 9), it is hereby issued with the approval of the State Drug Administration and shall come into force as of the date of promulgation.

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CDE publishes Technical Guidelines for Clinical Trials of Active Immunotherapy Products for Cancer (Trial)

On April 26, 2023, the Center for Drug Evaluation (CDE) of the State Drug Administration issued: In order to guide and regulate the clinical trials of tumor active immunotherapy products and provide referable technical specifications, under the deployment of the State Drug Administration, the Center for Drug Evaluation organized the formulation of the Technical Guidelines for Clinical Trials of Tumor active immunotherapy products (Trial). In accordance with the requirements of the Notice of the General Department of the State Drug Administration on the Release procedure of the Technical Guidelines for Printing and Distributing Drugs (Comprehensive Drug Administration of the State Drug Administration (2020) No. 9), it is hereby issued with the approval of the State Drug Administration and shall come into force as of the date of promulgation.

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CDE releases "Guidelines for Pharmaceutical Research and Evaluation of Human Stem Cell Products (Trial)"

On April 27, 2023, the Center for Drug Administration (CDE) of the State Drug Administration issued: In order to regulate and guide the pharmaceutical research, production and registration of human stem cell products, under the deployment of the State Drug Administration, the Center for Drug Administration organized the formulation of the "Technical Guidelines for Pharmaceutical Research and Evaluation of human stem cell products (Trial)". In accordance with the requirements of the Notice of the General Department of the State Drug Administration on the Release procedure of the Technical Guidelines for Printing and Distributing Drugs (Comprehensive Drug Administration of the State Drug Administration (2020) No. 9), it is hereby issued with the approval of the State Drug Administration and shall come into force as of the date of promulgation.

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National Health Commission issued: Somatic Cell Clinical Research Guidelines (Draft for Comment)

On May 9, 2023, the Science and Technology Education Department of the National Health Commission issued: In order to promote the healthy development of somatic cell clinical research initiated by researchers in medical institutions and strengthen the guidance for medical institutions to carry out somatic cell clinical research, the Guidelines for Somatic Cell Clinical Research (Draft for Comments) were drafted with reference to the management procedures and technical requirements of stem cell clinical research and combined with the characteristics of somatic cell clinical research.

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National Medical Products Administration issued clinical guidelines for human derived stem cells and derived products

On June 21, 2023, in order to provide technical guidance and suggestions for clinical trials of human stem cells and their derived cell therapy products, the CENTER FOR DRUG EVALUATION, NMPA issued the "Technical Guidelines for Clinical Trials of human stem cells and their derived cell therapy Products (Trial)", which will take effect from the date of release.

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The National Development and Reform Commission issued an announcement on the Guidance Catalogue for Industrial Structure Adjustment (2023 version, Draft for comment) for public comment

On July 14, 2023, the National Development and Reform Commission issued an announcement on the "Industrial Structure Adjustment Guidance Catalogue (2023 edition, Draft for Comment)" for public comment.

The "Catalogue (2023)" consists of three categories of encouragement, restriction and elimination, of which there are 5 items in the field of medicine that are encouraged, respectively: development and application of key core technologies in medicine; New drug development and production; Biomedical supporting industry; High-end medical device innovation and development; Traditional Chinese medicine inheritance and innovation.

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The National Development and Reform Commission and other departments have issued a document explicitly supporting private enterprises in scientific and technological research in six areas such as gene and cell medical treatment

The National Development and Reform Commission and other departments have issued a document explicitly supporting private enterprises in scientific and technological research in six areas such as gene and cell medical treatment

The circular issued 28 specific measures from five parts: promoting fair access, strengthening factor support, strengthening legal protection, optimizing enterprise-related services and creating a good atmosphere, while clarifying specific responsibility units. The notice proposed that private enterprises will be supported to participate in major scientific and technological research, and take the lead in undertaking research tasks in the fields of industrial software, cloud computing, artificial intelligence, industrial Internet, gene and cell medicine, and new energy storage.

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