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The Shenzhen Municipal People's Congress Standing Committee has officially released the "Shenzhen Special Economic Zone Regulations on Promoting the Cell and Gene Industry (Draft for Comments)."
2021-11-15
On November 12, 2021, Shenzhen's landmark legislation in an emerging field—the "Shenzhen Special Economic Zone Regulations on Promoting the Cell and Gene Industry (Draft for Comments)"—was publicly released for public input on the website of the Standing Committee of the Shenzhen Municipal People's Congress. The draft regulations provide clear guidelines for cell collection and storage practices. Specific regulations are established for expanded clinical trial systems of cell and gene therapies, while also encouraging the development and application of gene technology.
The draft regulations (for public comment) propose:
Chapter 4: Expanded Clinical Trials for Pharmaceuticals
Article 28 Cell and gene therapies currently undergoing clinical trials for life-threatening diseases with no effective treatment options—where initial observations suggest potential benefits and ethical requirements are met—may, after review and informed consent, be used within the medical institutions conducting the trials to treat other patients with identical conditions.
Cell and gene therapy drug applicants should apply for expanded clinical trials in accordance with national regulations.
Article 29 After cell and gene therapy applicants complete the clinical trial phase supporting the registration for a new drug to be launched on the market, and submit a marketing authorization application to the National Medical Products Administration, they may proceed with expanded clinical trials for these therapies.
Article 30: Applicants for cell and gene therapy drug registration are encouraged to communicate and exchange information with the Center for Drug Evaluation under the National Medical Products Administration, as well as other relevant authorities, both before initiating and during the conduct of expanded clinical trials for cell and gene therapies. Municipal market regulatory departments and other agencies should assist in establishing communication channels and provide necessary guidance and support services.
Article 31 Encourage cell and gene therapy applicants to provide expanded-access clinical trial versions of their therapies to patients with serious, life-threatening conditions that currently lack effective treatment options—provided it aligns with the patients' wishes and best interests. Safety data from these expanded-access trials can serve as valuable reference data when seeking regulatory approval for drug commercialization.
Article 32: Before conducting expanded clinical trials of cell and gene therapies, medical institutions and clinical trial sponsors must disclose to patients all essential information that may influence their decision-making. This includes the potential benefits, risks, adverse reactions, and available remedies associated with the use of cell and gene therapies. Additionally, they must specifically highlight to patients the sources of these risks as well as the possible consequences. Only after patients fully understand these matters should they sign an informed consent form.
If the patient is a minor, lacks civil capacity, or has limited civil capacity, the medical institution must disclose the matters specified in the preceding paragraph to their guardian and obtain the guardian’s signature on the informed consent form.
Article 33: Subjects have the right to withdraw from the expanded clinical trial of cell and gene therapies at any time they choose. Medical institutions and clinical trial sponsors must inform subjects about potential risks, adverse reactions, and available support measures that may arise after withdrawal.
Article 34: Clinical expansion trials of cell and gene therapies shall be terminated if any of the following circumstances occur:
(1) Serious, unexpected adverse reactions have occurred in the clinical application of cell and gene therapies;
(II) Quality issues arise with cell and gene therapies;
(III) Further clinical trial data for cell and gene therapies do not demonstrate efficacy;
(IV) Cell and gene therapies receive approval from the national drug regulatory authority for market launch;
(5) Other circumstances that do not meet the requirements for conducting expanded clinical trials.
Reprint Notice: This article is reprinted from the official website of the Shenzhen Municipal People's Congress Standing Committee. If there is any infringement, please contact us for removal.
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