How to Submit a DMF to China’s NMPA: Practice Points and Latest Updates

1.5
RAC Credits
Virtual ProgramsVirtual Programs
Thursday, 16 February 2023 (10:00 AM) - Thursday, 16 February 2023 (11:30 AM) Eastern Time (US & Canada)

China drug master filing (DMF) of active pharmaceutical ingredients (API), excipients and packaging materials presents complex challenges for international manufacturers. There’s legacy registration platform issues, language difficulties and local test requirements to contend with. This session delves into the law’s background and basic filing pathways before outlining practical tips about the process. It will also explore strategic approaches and alternatives. Interactive participation is highly encouraged to generate animated discussion.


REGISTRATION FEES & DEADLINES

7 December 2022—16 January 2023: Early Bird $150 Member | $175 Nonmember

17 January 2023—16 February 2023: Regular $175 Member | $200 Nonmember


Learning Objectives

After this program, participants will be able to:

  • Know key registration pathways for DMF of API, packaging and excipients
  • Appreciate likely manufacturer challenges
  • Develop strategies for obtaining DMF

Audience Learning Level:

Anyone from all levels of expertise is welcome to join this workshop.

Who Should Attend?

Regulatory affairs professionals and anyone interested in China DMF


Instructors:

Hamish King

Hamish King

Hamish King is COO at Cisema, a China-focused regulatory consultancy founded in Munich and Beijing in 2002. He specializes in NMPA registration. A lawyer by training—admitted in Hong Kong and New South Wales, Australia—Hamish previously worked with UK Magic Circle Firm: Linklaters in Hong Kong and has nearly 10 years' experience in the legal and regulatory fields. He holds RAC and CFA qualifications. King regularly publishes articles and speaks about Chinese market access and regulation. He resides in Hong Kong.

Guo Ning

Guo Ning

Guo Ning is General Manager of Cisema Beijing office and has nearly 20 years' experience in China regulatory affairs.


Cancellations

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org.  RAPS is unable to accept cancellations by phone.

To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.


Questions

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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