The Center for Drug Evaluation (CDE) is once again seeking public feedback on two key documents: the “Guiding Principles for Pharmaceutical Changes and Research Technologies of Biological Products during Clinical Trials” and the “Guiding Principles for Research Technologies of Pharmaceutical Changes in Marketed Vaccines”. These documents are open for public comments for a period of one month, following initial solicitation on September 10 and 2, 2020.
Applicability and Scope of the Guidelines
The “Guiding Principles for Pharmaceutical Changes and Research Technologies of Biological Products during Clinical Trials” apply to biological products that have obtained tacit clinical trial approvals within China, including both preventive and therapeutic biological products. The guidelines cover pharmaceutical changes or updates that occur throughout the entire “clinical trial period”, from obtaining tacit clinical trial approvals to submitting the marketing application. This includes aspects such as production raw materials, production processes, quality studies, stability, and container sealing systems. The document also serves as a reference for research and changes during clinical trials of advanced biological products like gene therapy and cell therapy.
Importance of Public Feedback
The CDE’s initiative to gather public feedback highlights the importance of stakeholder engagement in the regulatory process. It ensures that the guidelines are comprehensive, reflective of current scientific understanding, and aligned with international standards. The feedback period provides an opportunity for industry professionals, researchers, and other interested parties to contribute their insights and experiences, shaping the future of biological product regulation in China.-Fineline Info & Tech
