23/08/2022
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
11/08/2022
The French National Agency for the Safety of Medicines and Health Products (ANSM) has updated on 08/08/2022 its guidelines for the determination of financial penalties in case of non-compliance of pharmaceutical companies with the
14/04/2022
The war in Ukraine is causing disruptions in the conduct and planning of clinical trials. Although these disruptions are most severe in Ukraine, other countries are also affected, for example due to the arrival of refugees fleeing
07/04/2022
The guide for applicants and Marketing Authorization Holders (MAH) involved in GMP and GCP inspections coordinated by the EMA as well as the IRIS guide have been updated.Good Manufacturing Practices (GMP) are the principles and gu
22/03/2022
This new guideline, currently under public consultation, defines the elements of the pregnancy prevention programme and specifies when such a programme or other risk minimisation measures are necessary to prevent the adverse conse