Description: From latest updates through strategizing to the specifics of eCTD implementation, this global session examines China drug and drug master filing (DMF) regulatory pathways before analysing the specifics of Electronic Common Technical Document (eCTD) format for the submission of regulatory dossiers at the World Health Organization (WHO). China drug submissions and accelerated pathways are the starting point for the session, which first presents the latest key drugs policies introduced in recent years in China, with a particular focus on accelerated and special pathways such as Real-World Evidence (RWE) support. API, excipient and packaging master filings in China will then be analysed including practice points for accelerating submissions and renewals. Frameworks for drug manufacturers to better interact with API manufacturers will also be considered and discussed.
With the in-country example of China, the discussion will review a recent regulatory process change at the World Health Organization (WHO) which has now combined all 3 submission types (Finished Vaccine Products, Finished Pharmaceutical Products and API) together into a new Module 1. Challenges faced during implementation will be addressed, including issues related to data security, infrastructure, and varying degrees of regulatory maturity across different regions.
Learning Objectives:
Describe the standard drug registration procedures, accelerated pathways in China and registration strategy key considerations.
Describe the latest requirements for China filing of APIs (active pharmaceutical ingredients), excipients and packaging, and key practice points and related strategies
How to manage the shift from WHO CTD requirements to eCTD requirements
