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Regulatory Submissions and Interactions with NMPA: What You Need to Know

Increase your knowledge of the regulatory environment in China and best practices for interacting with NMPA and CDE with this on-demand short course.


Overview

The New Drug Administration Law and more than 100 regulations, guidance, policies and implementing rules were made 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 regards to 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 on-demand short course will highlight most relevant requirements and regulatory strategy to submit IND/NDA in China and review how to interact with NMPA/CDE effectively in the submission and approval process.

This on-demand short course takes 2.5 hours to complete.

Featured topics

  • Overview of the Regulatory System in China
  • Regulatory Submissions and NMPA/CDE Interactions
  • Special Topics

Who should attend?

This on-demand short course is designed for professionals involved in global drug development and submission process of IND/NDAs, and who interact with NMPA/CDE in the submission and approval process including:

  • Regulatory affair professionals
  • Drug development professionals
  • Project managers
  • Professionals involved in clinical trials

Learning objectives

At the conclusion of this short course, participants should be able to:

  • Define the drug regulatory system, reforms, and topics in China
  • Recognize the key elements of an IND and NDA application for a drug/biological product
  • Identify the accelerated regulatory pathways for the examination and approval of innovative drugs
  • Determine strategic considerations for the acceptance of global clinical data in China submissions
  • List good practices for effective CDE interactions

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Questions?