medicines-medical devices-regulatory affairs
The European Commission has published new and updated guidance documents in Volume 10 of “The Rules Governing Medicinal Products in the European Union”, which applies to clinical trials under the Clinical Trials Regulation (EU) No 536 These updates, published on…
In this post, information is provided on the following updated guidance documents: Changes to the guidance document Time limits for authorisation applications Swissmedic is shortening the procedural time limits for applications for new authorisation of medicinal products with known active…
Information on changes to the following guidance documents are provided below: Changes to the Guidance document Time limits for authorisation applications The international Project Orbis and Access Consortium procedures have been added to the updated Guidance document Time limits for…