Regulatory Blog

On 18 March 2022, EMA released updated guidance on "European Medicines Agency post-authorisation procedural advice for users of the...

Guideline on Good Pharmacovigilance Practices (GVP) for Pregnancy Prevention Programs A public consultation was launched by the European...

As part of the manufacturing import authorisation (MIA) process, the Annex outlines the GMP requirements that must be followed when...

ePI refers to medicines' authorised, statutory information (including summary of product characteristics, package leaflet and labeling)...

On 3-February, 2022 Ireland adopted a new guideline the "EU Clinical Trial Regulation" (Regulation No 536/2014, hereafter ‘CTR’), was...

This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have and...

This guidance document addresses a number of questions that marketing authorisation holders (MAHs) may have on post-authorisation...

This guideline addresses the methodological, regulatory and operational aspects involved in using registry-based studies to support...

European Commission’s Medical Devices Coordinating Group (MDCG) on 04-October-2021 issued guidance to support manufacturers classify...

As the eCTD format is mandatory for the submission of all applications for Certificates of Suitability to the monographs of the European...

The MDCG Guidance provides an overview of activities, requirements, auditing, surveillance and changes and minimum content of the...

This guidance document addresses a number of questions that users of the centralised procedure may have. It provides an overview of the...

The European Medicines Agency (EMA) on 22-July-2021 has adopted a guideline on the quality information that manufacturers of combination...

European Commission’s Medical Device Coordination Group (MDCG) released a new document on 13-July-2021, detailing the use of codes under...

European Medicines Agency (EMA) has assessed several rare adverse events for COVID-19 vaccines and one gene therapy for treating...

Introduction – EU Implementation Guide Following the publication of version 2.0 in February 2021, the content of sections 2. Chapters and...

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as an extension to the Pharmaceutical Inspection...

The European Medicines Agency (EMA) on 8th June 2021 launched a stakeholder consultation on a draft EU common standard for electronic...

EMA published the current version, version 2.0 (EU IG v2.0), in February 2021. It mainly serves to support the European medicines...