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Navigating China’s API Regulations: An Essential Guide to DMF Registration Training Course

Enhance your knowledge of the regulatory requirements for Active Pharmaceutical Ingredients and the Drug Master File in China. An opportunity to learn the quickest pathway options for DMF registration and to hear from industry leaders in this important region.

12 February 2025
+ 23 June 2025, 23 October 2025 »

from £150

Need help?  Enrol or reserve

Overview

As China becomes an increasingly important market for pharmaceutical companies, compliance and safety are crucial. 

This webinar has been designed to provide participants with a better understanding of the latest developments in China's Active Pharmaceutical Ingredients (APIs) regulations, including the new Drug Master File (DMF) registration routes that protect the confidentiality and interest of active drug substance suppliers.

Join our panel of industry experts as they discuss API registration in China and the quickest pathway options for DMF registration. Gain valuable insights into the related requirements and stay up-to-date with the dynamic and fast-changing regulations in China.

Don't miss this opportunity to enhance your knowledge of DMF, API, and China and learn from our industry leaders from this important region. 

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

Benefits of Attending

  • Gain in-depth knowledge and insights on how to register your Active Pharmaceutical Ingredient (API) in China
  • Stay up-to-date on the latest API and DMF regulations and requirements for China
  • Enhance your regulatory knowledge and skills for China and learn about the local requirements for Active Pharmaceutical  Ingredient (API) registration
  • Ensure compliance and safety by staying informed of the latest regulatory developments in China's API registration process
  • Engage with industry experts and get your questions answered in real-time
  • Gain competitive advantage by understanding the complexities of API registration in China and the quickest and most effective pathways for registration

Who Should Attend?

This webinar is designed for professionals who are involved in the pharmaceutical industry and need to understand the latest regulations on how to register APIs successfully in China. Targeted audience includes:

  • Regulatory Affairs professionals who need to stay up-to-date with the latest regulatory developments in China's API registration process
  • CMC Managers who need to ensure compliance and safety in the API registration process in China
  • Quality Assurance Managers who need to understand the local requirements for API registration in China
  • Project Management Professionals who are involved in the API registration process in China and need to ensure timely execution of the registration process
  • Business Planning Professionals who need to understand the complexities of API registration in China for successful business planning
  • Commercial Management Professionals who need to stay informed of the latest regulatory developments in China's API registration process for effective business management

Enrol or reserve

Helen Ye
Accestra Consulting

RA & PV Director at Accestra Consulting 

  • Ms. Ye has been dedicated to regulatory affairs consulting for 15 years with a Pharmacy degree from Zhejiang University, China. 
  • She is experienced in regulatory compliance of China market access & post-marketing maintenance of pharmaceutical products, providing insightful and customised solutions to international pharmaceutical companies and government institutions. 
  • She leads the registration team to plan, develop and implement compliance strategies for top pharma clients and has a successful track record for obtaining market approval for drug products, APIs, Excipients, Packaging Materials, medical devices and other products.
  • Ms. Ye has a strong communication network with Chinese authorities (e.g. NMPA and CDE) and industry experts in China. 
  • To learn more about Helen or Accestra Consulting, please visit their website at www.accestra.com

More details

April Wang
Accestra Consulting

Senior Regulatory Affairs Manager 

  • Ms. Wang is a senior regulatory affairs consultant specializing in the Chinese market with a Double Master’s Degree from Fudan University and Luiss Guido Carli University.
  • She has in-depth understanding on Chinese Pharmaceutical regulations and accumulated extensive hands-on experience with API DMF registration & regulatory consulting projects during daily work.
  • Ms. Wang has strong communication network with Chinese authorities including NMPA and CDE.
  • A successful track record with supporting international pharma with market entry into China including big and small pharma.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

12 February 2025

Live online

09:00-10:30 UK (London) (UTC+00)
10:00-11:30 Paris (UTC+01)
04:00-05:30 New York (UTC-05)
Course code 14476

  • GBP 150 175
  • EUR 220 255
  • USD 250 289

Until 08 Jan

View basket 

 
Not ready to book yet?

for 7 days, no obligation

23 June 2025

Live online

09:00-10:30 UK (London) (UTC+01)
10:00-11:30 Paris (UTC+02)
04:00-05:30 New York (UTC-04)
Course code 15245

  • GBP 150 175
  • EUR 220 255
  • USD 250 289

Until 19 May

View basket 

 
Not ready to book yet?

for 7 days, no obligation

23 October 2025

Live online

09:00-10:30 UK (London) (UTC+01)
10:00-11:30 Paris (UTC+02)
04:00-05:30 New York (UTC-04)
Course code 15246

  • GBP 150 175
  • EUR 220 255
  • USD 250 289

Until 18 Sep

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Germany

  • CHEPLAPHARM Arzneimittel GmbH

Spain

  • Italfarmaco S.p.A.

Enrol or reserve

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy