Regulatory Blog

Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. EU regulators first became...

On 8 July 2022, EMA updated its Products Management Services - Implementation Guide "Implementation of International Organization for...

Recently EMA released new guidance for "patients and healthcare professionals’ organisations" with key principles and examples of good...

A technology capability investment plan has been published by the European Medicines Agency (EMA), which outlines how it plans to invest...

On 2 June, an official Q&A prepared by the European Commission (EC), European Medicines Agency (EMA), and the Heads of Medicines Agencies...

European Medicines Agency (EMA) has issued a final guideline on evaluating antibacterial medicines that follow the guidelines of other...

Yesterday the European Medicines Agency released updated IRIS guidance on "How to create and submit scientific applications, for industry...

On 7 April 2022, European Medicines Agency released a draft guidance document on how to approach the protection of personal data and...

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)...

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...

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...

Clinical Trials Information System (CTIS) will act as the single entry point for clinical trials authorisation and supervision in the...

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

The European Medicines Agency (EMA) has issued a list of five preferred therapeutics for COVID-19 patients, including four monoclonal...