Hong Kong Launches Expedited Drug Registration Process & Becomes ICH Observer
Hong Kong is taking incremental steps to move towards a system where it can evaluate and approve new drugs more quickly and efficiently on its own. The moves include preparations for a new Hong Kong Centre for Medical Products Regulation.
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EMA Considers Product Development Stage For Complying With ICH Guide On Bioanalytical Method Validation
The European Medicines Agency has drafted a plan to address specific issues that drug companies may face when it comes to complying with the International Council for Harmonisation’s M10 guideline.