Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals

EJNMMI Radiopharmacy and Chemistry

Table 4 Risk categories dependent on effective dose. Limits valid for population < 50 years, excluding paediatrics

Benefit	Risk	Risk category	Probability	Effective dose [mSv]
Low	Not significant	I	≈ 10^–6 or less	< 0.1
Moderate/medium	Intermediate	II
		IIa	≈ 10^–5	0.1–1
		IIb	≈ 10^–4	1–10
Significant	Moderate	Cat. III	≈ 10^–3 or more	> 10

For paediatrics, limits have to be decreased by a factor of 2–3. For population > 50 years, limits may be increased by a factor of 510 (from Commission and Directorate-General for Environment NS and Civil Protection 1999)