Environmental Risk Assessment (ERA) – revised guideline to assess risk of human medicines for the environment…….

An Environmental risk assessment (ERA) of medicines ensures that the potential effects of pharmaceuticals on the environment are studied and that adequate precautions are taken in case specific risks are identified. The EMA has published a revision of its guideline on the environmental risk assessment (ERA) of human medicines for a six-month public consultation. Stakeholders […]

Brexit – because it affects you too…

The European Union is arguably the world’s most powerful bloc and very soon it’s about to lose the United Kingdom, one of its biggest members. How and when the UK leaves the EU will have further implications that ripple around the globe. So if you’ve heard about Brexit but haven’t been keeping up with every […]

Preparing for Brexit

As the date for the withdrawal of the UK (also known as Brexit) from the EU approached closer, it pays to hope for the best and prepare for the worst.  With this in mind, the EMA have issued a guidance document on “Practical guidance for procedures related to Brexit for medicinal products for human and […]

ICH Elemental impurities

New ICH guideline Q3D on elemental impurities (EMA/CHMP/ICH/353369/2013)

Elemental impurities guideline What is it… The ICH has introduced this new guideline to control the elemental impurities that may be present in drug products. It replaces EMEA guidance on Specification limits for residues of metal catalysts or metal reagents (EMEA/CHMP/SWP/4446/2000). This guideline applies to new drug products (with a new drug substance) and to […]

Points to note on the eAF

General The eAF is mandatory for all procedures from 01/01/2016 (CP, MR, DC, National in eCTD/NeeS/Paper). However, Presubmission Meeting Requests, Article 61(3) & MAT forms remain the outside scope and can be submitted as paper or PDFs. Please contact us if you require any assistance with any of the forms or any advice on any […]

PSUR repository updated

On the 26th of January 2015, the EMA introduced the pilot phase on the use of the XML delivery file for submissions of PSURs via the eSubmission Gateway/Web Client. This introduction, 1) Simplified package file names for PSURs and 2) Introduced the requirement of an XML delivery file. The XML delivery file is created in […]

EMA introduces changes to the QRD templates

The EMA has introduced changes to the QRD templates of the product information that accompany all medicines authorised for use in the EU including package leaflet (PL) and the summary of product characteristics (SmPC). Full details are available here: Summary of Main Changes: The changes to Quality Review of Documents (QRD)  templates are detailed in […]