Regulatory Affairs

The mission of the Regulatory Affairs department is to get safe and effective medicines to patients as quickly as possible.

To that end, we coordinate between Astellas Europe and worldwide regulatory agencies, such as the Food and Drug Administration (FDA), the European Medicines Agency (EMEA), and National Competent Authorities, in order to ensure that new Astellas drugs are granted registrations with optimal competitive labeling. By collaborating with multiple departments within the company, we also advise our research, development, and manufacturing departments about the laws, regulations, and guidelines from these regulatory agencies and applicable to the development of our products. When appropriate, advice from the agencies during development will also be sought by means of scientific advice procedures.

Additionally, we support the maintenance and regulatory compliance of existing marketing authorisations of our products in the European business region (Europe, Middle East, and Africa).