Regulatory

We have compiled a summary of links that may be helpful in the daily work of a regulatory affairs manager. These links refer to public databases of medicinal products, as well as homepages of regulatory agencies, legislations including detailed information on selected regulatory procedures, such as orphan drugs and paediatric investigational plans.

• Public Databases
• Orphan Drugs
• Paediatric Regulation
• Authorisation
• Advanced Therapies (ATMP)
• Biosimilar
• Agencies