The new MHRA’s framework for clinical studies
By Giuliana Miglierini The repositioning of the United Kingdom as a global leader for clinical development of medicinal…
EMA, new features for the PRIority Medicines (PRIME) scheme
By Giuliana Miglierini Based on the review of results obtained in the first five years of implementation of…
The EU Commission proposal of the new pharmaceutical legislation
By Giuliana Miglierini After a five-months delay, the European Commission has announced on 26 April 2023 its proposal…
The new guideline on combination products between medicines and medical devices
by Giuliana Miglierini The new “Guideline on quality documentation for medicinal products when used with a medical device”…