Croatia/Canada Begin Information Exchange On Pharma GMP Under EU Mutual Recognition Agreement
This article was originally published in SRA
Executive Summary
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...
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
EU Regulators Explain How To Ensure Transitioned Trials Align With CTR
Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.