China’s NMPA Introduces New Revised Regulation for Drug Approval by Foreign Companies

Overview: China’s National Medical Product Agency (NMPA) proposes a revision on pharmaceutical approval. The revision focuses mainly on generic drugs and how to increase the safety requirements for clinical trials, limit false clinical data and encourage drug approval process. China additionally released the second batch of urgently needed drugs from foreign manufacturers.  New Drug Review […]

Japan PMDA Raising Medical Device Registration Fees

[vc_row][vc_column][vc_column_text]On April 1st, 2018, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has raised the registration fees for most medical devices . PMDA fee increase is ranging from 8% to 15% across nine device categories as …