The Chinese regulatory landscape seems unique from and harmonious with global standards and practice. Since 2015, Chinese GCP guidelines published by the China Food and Drug Administration (CFDA) have been amended significantly, of which some good clinical practices (GCP) are overturning common ways that were implemented since 2003. The CFDA is updating the drug category and IND/NDA process for the regulatory registration purpose, and enhancing inspective forces on the quality and integrity of clinical trial outcomes. The procedures of IND/NDA review and approval have been greatly reformed. The quality of trial data is becoming more essential as evidence of supporting NDA approval. All of these updates are sure to impact the IND/NDA drug R&D strategies in China. This course will provide insights into critical considerations impacting IND/NDA practices involving drugs development in China and current CFDA reformations of regulatory submission review and approval.
Who should attend?
At the conclusion of this course, participants should be able to:
- Describe basic CFDA regulatory requirements for an IND/NDA process
- Explain Chinese regulatory practice and trends for reviewing and approving submissions of drugs
- Discuss the updated Chinese GCP guidelines for IND drug trials
- Explain how to be compliant with Chinese GCP standards in the implementation of clinical trials
- Complete the IND/NDA application process to the CFDA.