CDE solicits opinions on the "Detailed Rules for Application and Management of Class I Conferences in Advanced Therapeutic Drug Communication", aiming to accelerate the review of cell and gene therapy drugs
Recently, the Drug Review Center (CDE) of the State Drug Administration issued the "Detailed Rules for Application and Management of Class I Conferences in Communication and Exchange of Advanced Therapy Drugs (Draft for Comments)", aiming to optimize the review process of advanced therapeutic drugs such as cell and gene therapy (CGT) and accelerate the marketing process of innovative drugs. This move has attracted widespread attention from the industry and has become one of the hot topics in the past 10 days.
Policy background and core content
With the rapid development of global biomedical technology, the field of cell and gene therapy has become an important direction for innovative drug research and development. However, due to technical complexity and regulatory speciality, the review and approval of CGT products faces many challenges. The draft for soliciting opinions released by the CDE mainly puts forward detailed requirements for the application and management of Class I meetings to improve communication efficiency and quality.
Core contents include:
| Classification | Specific requirements |
|---|---|
| Conference Type | Clarify that Class I conferences are suitable for communication at important nodes such as key preclinical and clinical trials |
| Application time limit | Applicants must submit their application at least 30 natural days before the date of the planning meeting |
| Information requirements | Complete meeting materials need to be submitted, including research plans, data summary, etc. |
| Feedback time | The CDE will provide feedback on whether it agrees to hold a meeting within 15 working days after receiving the application |
Industry response and data analysis
After the policy was released, industry experts and corporate representatives generally welcomed it. According to the public opinion monitoring data in the past 10 days, it shows:
| platform | Related discussions | Positive evaluation proportion |
|---|---|---|
| 1,200+ | 85% | |
| 800+ | 78% | |
| Industry Forum | 500+ | 92% |
From the perspective of hot topics of discussion, it mainly focuses on the following aspects:
1.Improved review efficiency: A clear time node can help shorten the drug development cycle
2.Clear technical requirements: Provides clearer R&D guidance for enterprises
3.International connection: Drawing on the advanced experience of international regulatory agencies such as the FDA
Impact on the industry
The implementation of this policy is expected to have a profound impact on the cell and gene therapy industry:
| field | Potential impact |
|---|---|
| R&D investment | May stimulate more capital to enter the CGT field |
| Speed of listing | It is expected to shorten the launch time of innovative drugs by about 6-12 months |
| International cooperation | Promote technical exchanges and cooperation between domestic and foreign enterprises |
Expert opinion
Several industry experts expressed their opinions on this:
"The issuance of this detailed rule is an important step in the reform of China's drug review and approval system, and will significantly improve the predictability of innovative drugs." - Executive Chairman of the China Medical Innovation Promotion Association
"A clear communication mechanism can help reduce R&D risks, especially for high-investment cell and gene therapy products." - CEO of a well-known biopharmaceutical company
Looking to the future
With the advancement of soliciting opinions and the formal implementation of the detailed rules, it is expected that China's cell and gene therapy industry will usher in new development opportunities. The CDE also stated that it will continue to optimize the review process to provide a better policy environment for innovative drug research and development.
This policy adjustment not only reflects the regulatory authorities' attention to emerging technology fields, but also demonstrates China's determination to accelerate the approval of innovative drugs. Against the backdrop of increasingly fierce global biomedical competition, this move will further enhance China's international competitiveness in this field.
It is worth noting that the deadline for soliciting opinions is November 30, 2023. Industry companies and experts can make valuable suggestions during this period to jointly improve this important policy.
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