Croatia/Canada Begin Information Exchange On Pharma GMP Under EU Mutual Recognition Agreement
This article was originally published in SRA
A mutual recognition agreement that allows Croatian drug agency HALMED and Health Canada to exchange information on good manufacturing practice requirements for medicinal products became operational on April 1. Under the agreement, the two agencies can now exchange information on marketing authorizations and safety of medicinal products, accept manufacturing licences as well as accept and exchange GMP certificates1.
You may also be interested in...
A draft EU guideline explains how disease registries can be used to supplement evidence in the pre-authorization phase and provide infrastructure for post-authorization evidence generation.
Companies are being encouraged to become “early adopters” of the EU Clinical Trials Information System when it goes live in December 2021.
Drug companies will be able to “play around” with the new EU Clinical Trials Information System in a secure testing environment before it goes live in approximately 15 months.