Cisema is delighted to hold a Masterclass with Regulatory Affairs Professionals Society (RAPS) on April 7, 2022. 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.
Webinar: How to Submit a Drug Master Filing (DMF) of API, Excipients & Packaging to China NMPA
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.
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.
Presenters
Guo Ning
General Manager Cisema Beijing
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.
Hamish King
COO of Cisema Group
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.
Contact Cisema if you would like to learn more about the event or register here.
