On February 9, 2025, the Center for Drug Evaluation (CDE) announced the release of the “Guideline for Acceptance Review of Biological Product Registration (Trial)” (No. 15 of 2025), set to take effect on March 10, 2025. This significant update aims to standardize the formal review process for biologics registration acceptance, offering clearer guidance for applicants to ensure regulatory compliance.
Key highlights of the guideline include:
- Refined submission requirements to streamline the acceptance review of biological product registration.
- Applicability to all categories of biological products, requiring manufacturers and developers to reassess compliance strategies.
- An implementation date of March 10, 2025, allowing stakeholders time to align their documentation with the new standards.
This regulatory initiative reflects CDE’s ongoing commitment to enhancing oversight and regulatory clarity within the biologics sector, potentially impacting product development timelines and market entry strategies.
