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July 25, 2022
What is ILAP? What benefits does ILAP provide? How do you access it? With the dust of Brexit settling, the question on most people’s lips (well, those of us in the healthcare sector anyway!) was:...
July 21, 2022
Draft Guidance July 2022 This guideline provides recommendation to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical...
July 19, 2022
EMA Pre-authorisation guidance Table of contents 1. Types of applications and applicants 2. Steps prior to submitting the application 3. Preparing the dossier 3.1 Product name, product information...
July 13, 2022
The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines...
July 7, 2022
This guidance document aims to provide interested parties with appropriate guidance on procedural aspects to facilitate the consultation procedure to the European Medicines Agency (EMA) by notified...
July 5, 2022
News 01/07/2022 On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve during a workshop...
July 5, 2022
In 2020, the European Commission (EC) requested EMA and European Food Safety Authority (EFSA) for advice for the development of a harmonised approach on exposure assessment methodologies for residues...
June 28, 2022
Advanced therapy medicinal products (ATMPs) have emerged as ground-breaking therapies for rare diseases and other conditions with unmet clinical needs. As of 2022, sixteen ATMPs have been approved by...
June 24, 2022
8 June 2022 EMA/175959/2021 Rev.2 Human Medicines Division Regulatory and procedural requirements Introduction In order to ensure the continued effectiveness of authorised COVID-19 vaccines, it may...