Regulatory Endorsements from PMDA and NMPA

After reaching consensus with a client on a development strategy, Ascent works to gain endorsement of a proposed approach through formal interactions with PMDA and NMPA.

PMDA issues official written endorsements of development strategies through a well-established and transparent consultation system that provides clarity and assurance regarding viability of a specific regulatory pathway towards approval and marketing in Asia’s largest pharmaceutical market. Likewise, China’s recently streamlined IND review procedures, including a well-defined Pre-IND consultation process, allows sponsors to more efficiently gain clarity about development requirements to obtain marketing authorization in what is soon to become the world’s largest economy. Ascent navigates these regulatory complexities with clients to maximally harmonize development approaches for PMDA and NMPA, the regulatory keys to Asia’s largest pharmaceutical markets.