Global Regulatory Partners GK located in Tokyo Japan, is the In Country Caretaker (ICC) for Novavax. GRP’s role, as ICC, is to represent, develop regulatory strategy, prepare documentation, and communicate with PMDA (Pharmaceuticals and Medical Devices Agency) on behalf of Novavax.

“We are thrilled and congratulate Novavax for successful approval of their mRNA based COVID vaccine by PMDA. This is a significant milestone in GRP Japan’s journey and a testimony to our commitment to our clients’ success in Asia”, stated Dr. Suzan Davis, CEO of Global Regulatory Partners.

GRP Japan’s team, using their 30+ years of diplomatic experience with PMDA, have spent thousands of hours to meet the critical deadlines from PMDA. GRP has worked closely with Novavax’ European team to meet inquiry timelines sometimes as short as 24 hours. The approval was received on 19th April following over five months of communication back and forth with PMDA.

“We truly appreciate all of GRP’s help and guidance with this program, and their diplomacy with the PMDA on behalf of Novavax”, Patrick H. Warren, MPH, Associate Director, Global Regulatory Affairs (RoW Initiatives) at Novavax.

The vaccine from Novavax is expected to be available in Japan in late May 2022.