Technical barriers | Market barriers |
• Lack of capacity (time slots) to produce the batches for the validation • Lack of available alternatives • Technical complexity • Effort to demonstrate that the change does not impact safety and function of the product | • Contractual obligations to keep the existing formulation until the contract ends • Contractual necessity giving advanced notification of changes • Market acceptance of the products manufactured with the alternative |
Economic barriers | Regulatory barriers |
• Costs to revise an existing product in comparison with the potential income which can be generated • Lack of capacity, essentially human resources, in R&D • Time consumed to find an alternative and to validate it as compared to the remaining life cycle | • Time span to generate additional data to support change registration • Time span to achieve regulatory approval • Costs for testing, dossier generation and authority fees |