Market approval is mandatory at various milestones in the development of novel (bio)medical intervention and is the gateway all new interventions must pass to benefit patients. The regulation of medical interventions is often experienced as very complex and confusing. One of the reasons is that it is difficult to identify the relevant guidelines and guidances for a specific intervention or product.

The Market Approval Navigator is designed as a practical and easy to use tool to quickly identify relevant documents and their source (EMA, FDA or ICH).

This tool is your virtual assistant to help gain insight in the guidelines and regulations for your specific medical invention. The current version of the MAN tool is still under development and we highly appreciate comments, suggestions and corrections from users. Use the feedback button in the tool to send us a comment. We are grateful for your help and feedback.

Several unique features: