The verification of the compliance with the regulations in force, in particular with the Good Manufacturing Practice (GMP), Eudralex vol.4,...
The market shortage of medicinal products is now a global issue, that is continuously discussed by regulatory authorities and trade...
A new decree of the Italian Medicine Agency is in the process of being published in the Official Journal, laying...
In the world of health and wellness, a graphic error is not only an aesthetic issue: it’s a legal and...
The European Medicine Agency (EMA) has introduced some important novelties for the management of drug regulatory data, starting the switch...
Delegated Regulation (EU) 2016/161 of the European Commission (integrating Directive 2001/83/EC of the European Parliament and of the Council) provides...
Human medicinal products The importance of readability in package information leaflets and drugs’ packs is a topic that is becoming...
The Guideline for Good Clinical Practice (GCP) E6(R3), published on 6 January 2025 by the International Council for Harmonisation (ICH)...
In spite of the economic recession that has struck Europe and global markets, the pharmaceutical industry is still a stable...
This year will open with the entering into force of the Delegated Regulation (EU) 2024/1701 of 11 March 2024 amending...