Regulatory Blog

Earlier today (27 February 2023) European Medicine agency released an updated "Procedural Advice on Recommendations on unforeseen...

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

Yesterday (16-January-2023) European Medicines Agency (EMA) released an udated guideline "Information note on the format and validity...

European Medicines Agency (EMA) recently updated (14-October-2022) its guidance on "Scientific advice and protocol assistance" and also...

Earlier on 27th Spetmber, 2022 EMA revised and released their updated Regulatory and procedural guideline on "Checking process of...

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...

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 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)...