Welblu Thinking
Think and Thrive
This guideline describes the information that should be presented in the Quality part of a marketing authorisation dossier for a medicinal product when it is used with a medical device, or device part, and submitted in accordance with Directive 2001/83/EC and/or Regulation (EC) 726/2004. This guideline focuses on product-specific quality aspects of a medical device,...
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access. For more details, please click on the link
7th Invitation to Manufacturers of therapeutics against COVID-19 to submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Unit. The current Invitation is published in accordance with the Procedure for Prequalification of Pharmaceutical Products, adopted in 2001 by the 37th WHO Expert Committee on Specifications for Pharmaceutical Preparations,and amended subsequently as...
