Radiopharmaceuticals – How to Register in EU?

Author
Published on

Radiopharmaceuticals are a specific type of medicinal products. When ready for use they contain one or more radionuclides (radio-isotopes). Radionuclides dissipate excess energy by spontaneously emitting radiation in the form of alpha, beta, positron and gamma rays. Radiopharmaceuticals make use of the radiation emitted by radioisotopes. They are used for therapeutic (destruction of diseased body cells) and diagnostic purposes (detection of radiation and transforming into images).

Is a radiopharmaceutical a human medicinal product and under what conditions does it require registration?

Explore Starodub updates

Investing in ATMP or Biologics? Regulatory risk is value critical.

Four challenges from MEB’s State of Implementation report

Transitioning to the EU In Vitro Diagnostic Regulation: is your IVD technical documentation ready for submission?

Valentyna Starodub
Founder and Chief Executive Officer
Valentyna Starodub

Let's Connect

Talk to an expert