How to Submit New Drug Application (NDA) in China
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[Tuesday , 6th Dec 2022]
How to Submit New Drug Application (NDA) in China
Grace Wang
REACH24H Consulting Group China
FREE
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Background

Encouraging the development and marketing authorization of new drugs has been a highlight in China's reform started in 2015 for improving the drug review and approval system.

Expedited programs have been launched for the Center for Drug Evaluation (CDE) to prioritize the review and accelerate the approval of new drugs with significant clinical value, especially orphan drugs for rare diseases, pediatric drugs, drugs for major infectious diseases, and drugs urgently needed for public health.

Also, China has become more integrated into the international drug regulatory system since joining the ICH in 2017. Thus, China's regulatory environment is improving for overseas new drugs to seek marketing authorization.

With total drug sales scoring 1,558.5 billion yuan (circa 214.9 billion USD) in 2021, China continues attracting drug companies as a considerable pharmaceutical market. To help pharma companies register new drugs in China, this webinar will introduce the regulatory requirements for submitting new drug applications (NDAs) to CDE.

Contents

1. China's drug regulatory environment

2. Definition and classification of new chemical drugs

3. Whether CDE accepts overseas clinical data

4. Expedited programs for drug registration

5. NDA submission: dossier, procedure, timeline, and fee

6. Pre-approval inspection

Speakers
Grace Wang
ChemLinked Regulatory Analyst
Grace Wang is a regulatory analyst and editor specializing in China's pharmaceutical regulations and market trends. She provides news and insights to help overseas pharma companies enter the Chinese market. Her areas of focus include DMF filing, new drug application, pharmacovigilance, and the volume-based procurement policy.