CDE seeks comments on technical guidance for pharmaceutical research and evaluation of gene transduction and modification systems

On September 30, 2020, the Center for Drug Evaluation (CDE) of the National Medical Products Administration began soliciting opinions on its official website regarding pharmaceutical research and evaluation techniques related to gene drugs. The full text is as follows:

Notice on publicly soliciting opinions on the Technical Guideline for Pharmaceutical Research and Evaluation of Gene Transduction and Modification Systems (Draft for Comment)

Release date: 20200930. To standardize the pharmaceutical research of gene transduction and modification systems for cell therapy products, unify evaluation standards, and guide the research and application of related products, our Center, based on drawing on relevant domestic and international regulatory standards and through preliminary research, document drafting, expert consultation and departmental discussion, has formed the Technical Guideline for Pharmaceutical Research and Evaluation of Gene Transduction and Modification Systems (Draft for Comment). We now solicit public opinions through the Center's website (www.cde.org.cn), and welcome valuable opinions and suggestions from all sectors.

If you have any opinions or suggestions for further improvement or supplementation, please fill in the specific information in the comment feedback form and provide feedback to us by email. Thank you for your participation and support! Contacts: Lu Jiaqi, Wei Wei. Email: lujq@cde.org.cn; weiw@cde.org.cn. The deadline for soliciting opinions: October 30, 2020.

Center for Drug Evaluation, National Medical Products Administration. September 30, 2020.

The CDE website also attached three original documents with the notice: Attachment 1: Technical Guideline for Pharmaceutical Research and Evaluation of Gene Transduction and Modification Systems (Draft for Comment).pdf; Attachment 2: Drafting Notes of the Technical Guideline for Pharmaceutical Research and Evaluation of Gene Transduction and Modification Systems (Draft for Comment).pdf; Attachment 3: Comment Feedback Form for the Technical Guideline for Pharmaceutical Research and Evaluation of Gene Transduction and Modification Systems (Draft for Comment).docx.

According to the requirements of the main text of the comment solicitation, this guideline provides advisory technical requirements for gene transduction and modification systems, aiming to provide guidance for the R&D and application of drug registration applicants (hereinafter referred to as applicants), and also serves as an important reference for regulators in supervising and evaluating gene transduction and modification systems used in the production of cell therapy products. For gene-modified cell therapy products registered as drugs, the gene transduction and modification systems used in their production, as key materials, are subject to the supervision of the National Medical Products Administration (NMPA). In R&D and application, while following this guideline, the relevant laws and regulations such as the Drug Administration Law of the People's Republic of China, the Measures for the Administration of Drug Registration and the Pharmacopoeia of the People's Republic of China shall also be complied with, and other relevant guidelines and subsequently issued regulations in this field shall be comprehensively referenced. The applicability to specific issues should be analyzed on a case-by-case basis.