Regulatory guidance opens for inquiries on August 1

Development of advanced therapies requires early regulatory clarification. Which legislation should you be aware of? What needs to be in place before a clinical trial can begin? Which authorities need to be involved?

ATMP Denmark offers non-binding regulatory guidance to public and private actors working on the development of or clinical trials with ATMPs in Denmark.

We are not an authority and cannot make decisions or assess data. That responsibility lies with the relevant authorities. In return, we can help you gain an overview of the process, identify regulatory issues, prepare important questions, and provide answers to the most common questions as well as find the right points of contact.

Among other things, you can get help with:
Clarification of regulatory questions in your specific project (e.g. approval process, requirements, and expectations for documentation).

Which requirements for later commercialisation and clinical implementation should be considered already in the early phase

Preparation for dialogue with regulatory authorities, including which questions are typically important to clarify early on, and what you may want to have ready.

We will do our best to answer your question.

How we help you आगे
Here you can read more about how to apply for regulatory support: Regulatory support