Market Approval Navigator
The Market Approval Navigator is designed as a practical and easy to use tool to quickly identify relevant documents for market approval of biomedical interventions. Guidelines and guidance documents from European Medicines Agency (EMA), US Food and Drug Administration (FDA) and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) can be searched simultaneously for 1 or several key words.
Please register to access the tool or login at the top of the page.
Why did we develop this tool?
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).
Why is this tool special?
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:
Simultaneously search EMA, FDA and ICH guidelines
Full text searching
Use 1 or more key words, Booleans and wildcards to find relevant documents
Advanced filter options to narrow down results
Read the documents straight from the tool or redirect to the source
Part of the course Market Approval
Market Approval is mandatory at various milestones in the development of your novel biomedical intervention and need to be passed to move your product to the market and beyond.