Regulatory Blog

Recently (19 January 2023) the European Medicines Agency released an updated guidance on "IRIS guide for applicants - How to create and...

Today (04 July 2023) the European Medicines Agency released a scientific guideline "Guideline for the notification of serious breaches of...

Today (27 June 2023), the European Medicines Agency released updated guidance on "Procedural Advice on Publication of Information on...

Earlier today (17 May 2023) the European Medicines Agency released an updated guidance document on "Good Practices for Industry for the...

Last Week (20 April 2023) the European Medicines Agency updated and released the guidance on "IRIS guide to Registration and RPIs" which...

Recently (9 March 2023) the European Medicine agency released a "Guideline on Computerised Systems & Electronic Data in Clinical Trials"...

On 16 February 2023, the European Parliament approved the European Commission's proposal for amending the EU's Medical Device regulatory...

On 11 November 2022, the European medicines agency released updated guidance for sponsors about the "Procedural Advice for Orphan...

Recently EMA released an updated guidance document for the purpose of simplifying the completion of the application form process for...

On 2-September, 2022 the European Medicines Agency released the updated IRIS guidance on "How to create and submit scientific...

On August 31, 2022 the EMA updated its guidance "Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by...

EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been...

On 22-August-2022, Sunlenca (lenacapavir) is an injectable HIV medication developed by Gilead Sciences that has been approved to market...

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...

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

On 20 May 2022 MDCG, the Medical Device Coordination Group of the European Commission has released a question and answer guide for the...

On 7 April 2022, European Medicines Agency released a draft guidance document on how to approach the protection of personal data and...