Clinical Research Solutions
EMA post-authorisation procedural advice for users of the centralised procedure
This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on...
Clinical Research Solutions
IRIS guide for applicants (How to create and submit scientific applications, for industry and individual applicants)
This guide has been produced to show applicants how to use the IRIS platform to prepare and submit an application and/or data for a scientific procedure (orphan designation application, scientific...
Clinical Research Solutions
EMA Regulatory and procedural guideline: Public consultation concerning the physical attendance and the location of personal residency of the qualified person
The COVID-19 pandemic required manufacturers and importers of medicinal products and regulatory authorities to operate under business continuity mode, impacting the standard way of working. As a...
Clinical Research Solutions
EMA and the EUnetHTA 21 consortium set priorities for their collaboration Share
April 12, 2022 The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a PDF icon joint work plan until 2023. The focus...
Clinical Research Solutions
Facilitating global access to diabetes treatments for non-EU patients Share
April 22, 2022 EMA’s human medicines committee (CHMP) has given a recommendation for two diabetes mellitus treatments, Actrapid and Insulatard, for use outside the European Union (EU). EMA is...