Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-519-L04-P; CME 2.75; IACET 2.75; RN 2.75
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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.
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DIA 2021 Who should attend? Regulatory affair professionals, senior management executives, drug development professionals, project managers, clinical trial specialists, people investing in biotech product development projects, consultants and foreign regulators.
Learning Objectives 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.
