Description: The size and fast-paced regulatory change of China's drug market impels rapid update cycles, for which regulatory frameworks in China especially for API, excipient and packaging manufacturers, are sometimes lagging. This session will open discussion for enabling appropriate compliance strategy and approaches for China DMF (drug master filing). It will help manufacturers appreciate and weight appropriate factors to develop a viable regulatory strategy for marketing in China in order to provide products for drug end-product manufacturers and ultimately patients (end-users). This will support firms to develop and expand in the world's second largest healthcare market. There is frequently a clear lack of information and guidance for China as compared with US or EU regulations, SOPs and quality requirements. So, the session will also cover practical considerations from a regulatory point of view: protection of intellectual property and safeguarding company interest while efficiently and optimally obtaining approvals and remaining compliant.
Learning Objectives:
describe the latest requirements for China filing of APIs (active pharmaceutical ingredients), excipients and packaging, and key practice points and strategy for same
explain strategic options of regulatory pathways for biopharmaceutical manufacturers for their DMF with China's NMPA
explain key considerations for China testing and dossier preparation for biopharmaceutical manufacturers as it relates to China DMF submission
