Scientific Advice & Agency Meeting
Scientific Advice and/or Agency Meeting is a service provided by regulatory authorities to support the development of medicinal products. The process allows medicine developers to seek guidance on specific aspects of their development plans, ensuring that appropriate tests and studies are conducted efficiently and to high scientific standards. Early advice can be valuable, particularly if guidelines are unclear for development of a novel therapeutic as an example.
Scientific Advice/Agency Meeting aims to address specific questions posed by developers regarding various aspects of medicine development, including:
- Quality of manufacturing processes
- Non-clinical studies
- Clinical trial design
- Regulatory matters
- Reclassification process
- Significant benefit for orphan-designated medicines
The Scientific Advice/Agency Meeting procedure typically follows a defined timeline, involving:
- Submission of questions by the developer
- Administrative validity of the request
- Review and discussion of the submission
- Preparation of a final advice letter
The benefits of a Scientific Advice/Agency Meeting are:
- Increased likelihood of marketing authorization success
- Streamlined development process
- Early identification and mitigation of potential risks
- Better understanding of regulatory expectations
Scientific Advice/Agency Meeting plays a crucial role in:
- Ensuring efficient and ethical drug development
- Facilitating communication between developers and regulators
- Improving the quality and completeness of evidence generated
- Potentially reducing time and costs associated with development
It’s important to note that while following Scientific Advice/Agency Meeting increases the chances of receiving marketing authorization, it does not guarantee approval.
While not legally binding, Scientific Advice/Agency Meeting is highly recommended and is a powerful tool for medicine developers, offering guidance through development challenges and establishing relationships with regulators.
As a solution, we offer:
- Guide you through the processes
- Support in the facilitation of Health Authority meetings with the purpose of driving decisions for drug development or marketing authorisation application;
- Help to draft the questions and company positions for the briefing package, presentations and the questions to be addressed to the Agencies
- Prepare and submit the advice package to the agency, and prepare for direct interactions with the agency during the advice procedure
- Work with you to identify which aspects of your development plan require advice from the regulatory agencies, and at which point in development.
Get in Touch
Have questions or need expert guidance on regulatory compliance? We’re here to help! Contact us today to discuss how NTLS can support your business.