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The European Medicines Agency has updated its templates for assessment reports on human medicines to include information on how medicines were studied in the elderly and on claims that a medicine contains a new active substance.
The new templates now aim to make sure that assessment reports include information on the number of elderly people involved in a medicine’s clinical-trial programme more clearly, as well as on side effects that are of significance in older patients, according to a statement on the Agency’s website.
From now on, the Agency will be asking applicants to supply this information in the list of questions at day 120 of the assessment procedure if they fail to include it in their dossier.
The updated templates also include additional sections on claims that a medicine contains a new active substance.
Applicants with ongoing procedures including such claims will be asked to supply this additional information at days 120 or 180, so that the responses can be assessed by the Committee for Medicinal Products for Human Use (CHMP).
The new information will be included in the assessment of medicines for use in humans, and will appear in the final European public assessment reports at the end of the authorisation process.
