Authorization Holder Scheme To Shake Up China R&D, Production
This article was originally published in PharmAsia News
China is to introduce on a pilot basis in 10 provinces a new marketing authorization holder scheme, under which a manufacturing site will no longer be required for a drug approval. The change will allow researchers and institutions to hold approvals and is expected to spark changes in both the R&D and contract manufacturing sectors.
You may also be interested in...
WuXi Biologics is aiming high to become the world’s biggest biologics manufacturer within five years after seeing strong confidence from capital markets in its growth potential and a boost from its new biologics manufacturing facility. The Chinese company plans on more investment in early 2018 to prepare for an expected biologics surge in China, its chief executive tells Scrip.
After one year of testing the waters, China’s Drug Marketing Authorization Holder system is likely to have an earlier than expected start to the launch of final law amendment procedures, since the pilot scheme has significantly reduced investment duplication and encouraged pharma companies to file more innovative drug applications.
With the fourth quarter just around the corner, China's closely-watched annual drug reimbursement and prices negotiations are entering a key final stage. But will applicants need to be more strategic than expedient?