By Fineline Cube 
The Center for Drug Evaluation (CDE), part of China’s National Medical Products Administration (NMPA), published the Detailed Rules for the Application and Management of Class I Meetings on Communication Regarding Advanced Therapy Medicinal Products (Draft for Public Comments). The draft invites public input for one month from the release date and outlines a streamlined 30‑day review process for key advanced‑therapy product communications.
Scope of the New Rules
The regulations apply to three distinct scenarios involving advanced therapy medicinal products (ATMPs):
- Breakthrough Therapy Designation – ATMPs that have received NMPA’s Breakthrough Therapy Designation.
- Gene‑Therapy Targeting Inherited Disorders – Gene‑therapy products designed to correct underlying genetic defects.
- Pre‑Pivotal Communication – ATMPs that have completed exploratory trials and seek a meeting before pivotal/confirmatory studies or NDA submission.
Class I Meeting Framework
- Classification – All meetings under the three scenarios are designated Class I.
- Purpose – Accelerate regulatory dialogue, reduce lead times, and improve communication efficiency.
- Timeline – Targeted 30‑day turnaround from application to meeting scheduling.
- Management – Dedicated CDE review panels will assess applications, ensuring consistency and speed.
Public Participation
CDE’s draft invites stakeholders—pharmaceutical companies, biotech firms, clinical researchers, and patient advocates—to submit comments within one month. Public feedback will shape final regulatory language and operational guidance.
Market Impact
- For Innovators – Faster access to regulatory guidance may shorten development timelines for breakthrough and gene‑therapy products.
- For Investors – Clearer, faster communication pathways reduce risk and can accelerate time‑to‑market valuations.
- For Patients – Accelerated development of ATMPs could bring innovative therapies to Chinese patients more swiftly.-Fineline Info & Tech