New Drug Administration Law and more than 100 regulations, guidance, policies and implementing rules are effective in 2020. The framework for regulatory oversight of China’s National Medical Products Administration (NMPA) and NMPA’s Center for Drug Evaluation (CDE) has changed significantly in the decision-making for the supervision and administration of drugs, and in the evaluation of drug clinical trial applications, drug marketing authorization applications, supplementary applications, and overseas drug production registration applications. This short course will highlight most relevant requirements and regulatory strategy to submit IND/NDA in China and discuss how to interact with NMPA/CDE effectively in the submission and approval process.
Need approval in order to attend?
Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings.
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Upon completion of registration, participants will gain access to the following:
- Live Event Access
- Presentation Slides
- Access to recorded sessions, on demand for 4 months post event
Who should attend?
- Define the drug regulatory system, reforms, and hot topics in China
- Highlight the key elements of an IND and NDA application for a drug/biological product
- Describe the accelerated regulatory pathways for the examination and approval of innovative drugs, e.g., oncology, orphan and cell/gene therapies
- Discuss strategic considerations for the acceptance of global clinical data in China submissions; Review good practices for effective CDE interactions
- Provide real-life case studies.