EMA Backs Six Drugs, One Biosimilar for EU Approval
By Michael Mezher -
Published 10 November 2017
The European Medicines Agency (EMA) on Friday said that its Committee for Medicinal Products for Human Use (CHMP) is recommending six new drugs, a biosimilar and three generic medicines for EU approval.
Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Submission and registration
Tags: Marketing Authorization Applications, CHMP, Accelerated Assessment, Orphan Designation, Biosimilar, Jorveza, Prevymis, Ocrevus, Adynovi, Fasenra, Intrarosa, Mvasi
Global Regulatory Strategy
By Prerna Menon -
Published 11 October 2016
This article discusses the development of a regulatory strategy allowing companies to identify opportunities and problems prospectively, improve utilization of company resources and focus the development team on the key objectives and assist in developing products with a positive benefit-risk profile demonstrating differential advantages and value for prescribers and payers.
Categories: Features, Japan, Canada, Europe, US, EMA, FDA, Health Canada, MHLW, PMDA, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration
Tags: Priority Review, Accelerated Approval, Breakthrough Designation, Fast Track Designation, Conditional Approval, PRIME, Adaptive Licensing, Accelerated Assessment, Sakigake