This validation checklist is used by the Agency to validate initial marketing authorisation applications for pharmaceuticals and applicants should use it as a means to review in advance of their submission that standard requirements are fulfilled.

The Medical Device Coordination Group (MDCG) has published MDCG 2021-24 Rev.1 (April 2026), updating its guidance on the classification of medical devices under MDR (EU) 2017/745. This revision provides further clarification and practical examples to support...

Over the last year, something shifted. The EMA–FDA joint Good AI Practice Principles (Jan 2026), the CIOMS Working Group XIV final report (Dec 2025), and the EU AI Act high-risk rules taking effect this August have moved AI in PV from "interesting pilot" to "regulated...

This presentation relates to Annex II.1 of ICH Q9(R1) To ensure the adequate management of risks and continuous improvement, it is essential for the principles and practices of QRM to be fully integrated within the PQS as outlined by ICH Q9 (R1). • ICH Q9 (R1) is not...