EMA Consults On Two-Step Process For Release And Shipping Of Investigational Products
The European Medicines Agency has issued a draft guideline to support the upcoming Clinical Trials Regulation, explaining how investigational medicinal products should be handled before they are sent to clinical trial sites.
You may also be interested in...
A new EU guideline explains how manufacturers and importers of investigational medicinal products can comply with the provisions of a 2017 delegated regulation specifying good manufacturing practice requirements and inspection procedures for such products.
Two new legal acts have been adopted by the European Commission specifying updated good manufacturing practice requirements for investigational medicinal products and finished medicines. The legislation take into account recent updates to the EU rules on the safety of medicines.
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.