Pharmacy compounding is one of the topics in the EU Pharma Law Package that has perhaps received less attention compared to topics such as regulatory exclusivity rights, shortages, and sustainability. The EU Pharma Law...more
In the Netherlands, the Central Committee on Research Involving Human Subjects (CCMO) recently published a guideline to clarify the requirements applicable to interventional studies with humans in the context of food,...more
As of 18 June 2024, the Revised CTIS Transparency Rules as adopted by the European Medicines Agency (EMA) apply, and will impact patients, health care professionals and sponsors. Also as of 18 June, a revised version of the...more