Medicines legislation

AxeRegel celebrates its 5th anniversary

Today we are celebrating AxeRegel’s 5th anniversary!Celebrate with us!AxeRegel is a regulatory affairs consultancy company focused on providing services in:Regulatory affairsQualityPharmacovigilanceMedical informationfor the pharm

Biosimilar medicines are interchangeable

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) decided to harmonise EU position on interchangeability of biological medicines by issuing a joint statement confirming that biosimilar medicines approve

Qualified Person deputy in France

The status of Responsible Pharmacist in a pharmaceutical company is specific to France and is regulated by the Public Health Code (CSP).In France, any company with at least one pharmaceutical establishment must be owned by a pharm

How clinical trials are changing in Europe

Clinical trials in human medicines are studies carried out in human volunteers intended to investigate the safety or efficacy of one or more investigational medicines.Clinical trials can only be started after a compound has passed

i-SPOC - Registration deadline coming soon!

The continued availability of medicines is one of the most important priorities for EU authorities. Indeed, shortages or other problems with the availability of medicinal products create challenges for the medicine supply chain an