EMA Identifies Steps To Foster ATMP Development
EU biotech companies have welcomed the various initiatives that the European Medicines Agency has listed to support the development of advanced therapy medicinal products. However, they want clear timelines on completing these initiatives since their implementation will not require any changes to the current legislative framework.
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EU biopharmaceutical industry group EBE says it is awaiting keenly the publication of good manufacturing practice guide for advanced therapy medicinal products, after learning that the European Commission is making changes to address concerns it had over the appropriate format of the document.
Pharmaceutical companies in the EU are becoming keener to experiment with genetically-modified advanced therapy medicinal products in patients, but they are finding it hard to navigate through the maze of environmental risk assessment procedures in each member state.
The European Medicines Agency's action plan to support the development of advanced therapy medicinal products will prioritize on actions that are feasible, will result in major gains without the need for a lot of effort and will not require legislative changes.