China GMP and Registration of APIs - Live Online Training

China GMP and Registration of APIs - Live Online Training

Course No 20624

All times mentioned are CET.

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Speakers

Marieke van Dalen, Global Regulatory Specialist, Aspen Oss, The Netherlands
Francois Vandeweyer, Freelance Consultant, Belgium, formerly Janssen Pharmaceuticals
Ellen Zandvoort,  Aspen Oss, Customer & Regulatory Support Officer, The Netherlands

Objectives

China first introduced GMP in 1988, and since then the GMP regulations are revised and updated several times. Most of the existing GMP requirements and guidance documents were updated by the so called National Medical Products Administration (NMPA), China’s new Drug Regulatory Authority since 2018, and replace former Guidelines published by the CFDA (China Food and Drug Administration). In 2021, the NMPA published a new guideline in regard on the inspection system and GMP certificates, which influenced the certification procedure tremendously.

Also in 2021, the NMPA issued new guidelines with information relevant for changes in registrations of drug products, for administrative and for technical processes. To keep track with the mandatory guidance documents of the regulatory authority as well as the understanding of the GMP requirements and registration procedures for APIs are the prerequisites  to register APIs in China. 

This Live Online Training provides an overview of the regulatory and GMP requirements regarding APIs in China.

Target Group

This Live Online Training has been developed for all who are dealing with API Sourcing, Manufacturing, Quality Assurance and Regulatory Affairs.

Technical Requirements

We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

API Registrations in China
Marieke van Dalen
  • Health authorities in China
  • The Chinese Drug Master File System
  • Bundled review
  • Specifics for the Chinese API Drug Master File
  • Common deficiencies
QC Testing: a China Specific Requirement
Ellen Zandvoort
  •  The procedure for QC testing
  •  Common observed hurdles with QC testing
China's Current View on Drug GMP
Francois Vandeweyer
  • Chinese GMP – general Topics
  • Chinese Drug GMP – on site inspection focus Points
  • Chinese GMP annexes with focus on Biologicals and the new Annex 13 for IMPs
  • Chinese quality management and equipment strategy to compete with the West
 
Take advantage of the experiences of our speakers and send us your questions related to China GMP and registration of APIs in China prior to the Live Online Training. Your questions are welcome and will be answered as comprehensively as possible by the experts during the Q&A sessions.

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