Regulatory Blog

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...

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

Medical Device Coordination Group Document (MDCG) published a guidance (MDCG 2021-19) note integration providing recommendations on how...

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

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

The European Commission’s Medical Device Coordination Group (MDCG) last week issued guidance providing a set of templates that will be...

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