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Europe: EMA offers insights on when biologics qualify as new active substances

2022/11/23  EMA

This document intends to clarify the elements that may be considered in support of a NAS claim for a biological active substance. It does not cover every possible scenario, and therefore applicants are invited to seek scientific advice on the evidence that may be appropriate to substantiate a NAS claim, especially for scenarios not covered in this reflection paper. The assessment of NAS concerns the active substance contained in the finished medicinal product and not the finished medicinal product in itself (i.e., the finished product composition is not considered). The NAS assessment is without prejudice to the CHMP opinion on the eligibility to the CP, or to differences in terms of International Non-proprietary Name (INN) of active substances in authorised, or previously authorised, medicinal products. Submitting a MAA under Article 8(3) of Directive 2001/83/EC does not automatically confer a NAS status, nor does submitting through the centralised route. NAS claims can only be considered in the context of the assessment of a MAA. The outcome of a NAS assessment has no retrospective impact on the eligibility granted to the CP. Applicants are invited to consult the ‘pre-submission guidance’ on the EMA website for further details on the eligibility for access to the CP.

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