EMA Tackles How To Substantiate New Active Substance Claims For Biologics & ATMPS
The European Medicines Agency is seeking feedback on its position on assessing whether biological substances and advanced therapy medicinal products qualify for NAS status.
You may also be interested in...
The European Patent Office has adjusted the starting date of its transitional measures for applicants that want their patent to have unitary effect under the coming Unified Patent Court system.
New EMA Innovation Group To Provide Point Of Entry For Developers & Contribute To Regulatory Assessments
The European Medicines Agency’s newly established Quality Innovation Expert Group will focus on innovative pharmaceutical manufacturing approaches, starting with continuous manufacturing for biologicals and end-to-end processes, and decentralized manufacturing.
The budget-neutral deal under which Takeda’s Exkivity was previously made available via the National Health Service is ending and being replaced by commercial supply at a confidential price.