How to Submit a Drug Master Filing (DMF) of API, Excipients & Packaging to China NMPA

2.0
RAC Credits
Virtual Programs Virtual Programs
Thursday, 07 April 2022 (8:00 AM) - Thursday, 07 April 2022 (10:00 AM) Eastern Time (US & Canada)

China has opportunities to improve alignment with other countries’ more established regulatory systems, and the introduction of the DMF system is a major step towards alignment with global pharmaceutical regulatory standards. It has similarities with the US FDA procedure but there are subtle differences, which this program will examine in detail.

The 2-hour live broadcast will provide an overview and details of drug master files (DMF) for active pharmaceutical ingredients (APIs), excipients and packaging materials (or AEP) for China NMPA.


Pricing Amounts & Deadlines

1 February 2022 – 7 March 2022: Early Bird $195 member | $230 nonmember

8 March 2022 – 7 April 2022: Regular $230 member | $270 nonmember

Learning Objectives 

After this program, participants will:

  • Understand the key regulations and process of China NMPA drug master filing.
  • Know the key components of the DMF filing structure.
  • Know best practices regarding DMF dossier content.
  • Have a thorough understanding of how to apply for and obtain a China DMF number.

Who Should Attend? 

By attending this program, regulatory professionals and overseas manufacturers will gain a thorough understanding of China DMF and better position themselves to meet the new requirements in China.

Agenda

  • Filing scope & overview 
  • Types of approvals 
  • NMPA Legal Agent 
  • Comparison: China, US & EU 
  • Post-approval matters 

The agenda may vary based on changing requirements.

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Instructors:

Guo Ning

Guo Ning  is an industry executive with degrees from Nankai University Tianjin (China) and University of Mannheim (Germany) who has developed a deep expertise in China market access issues via his experiences in industry, as a project manager at an import/export business, and as a technical compliance and product safety expert with Cisema for over 15 years.

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Hamish King

Hamish King is COO at Cisema and is admitted as a lawyer in Hong Kong and in New South Wales, Australia and formerly with Magic Circle firm Linklaters in Hong Kong. He lives regularly writes and presents on China regulatory affairs life sciences topics.

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Cancellation Policy

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. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. 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. 

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance following the workshop.

Questions

Contact the RAPS Solutions Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email raps@raps.org  

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