Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective

Affiliations

• ¹ European Medicines Agency, Amsterdam, The Netherlands.
• ² Spanish Agency of Medicines and Medical Devices, Madrid, Spain.
• ³ Swedish Medical Products Agency, Uppsala, Sweden.
• ⁴ Federal Institute of Drugs and Medical Devises, Bonn, Germany.
• ⁵ Norwegian Medicines Agency, Oslo, Norway.
• ⁶ INFARMED - National Authority of Medicines and Health Products, Lisbon, Portugal.
• ⁷ Medicines Evaluation Board, Utrecht, The Netherlands.
• ⁸ Federal Agency for Medicines and Health Products, Brussels, Belgium.