Webinar on reflection paper on the qualification of non-mutagenic impurities

EMA has launched a public consultation on the draft reflection paper on the qualification of non-mutagenic impurities, with the aim of gathering input and feedback from stakeholders. This draft follows the earlier version that was published in 2018 and has been updated considerably.

The update focuses on alternative strategies for qualifying novel impurities or qualifying higher levels of impurities that were previously qualified at a lower level. The aim is to provide a practical reference for applicants regarding the qualification of novel impurities:

• arising from changed manufacturing processes,
• discovered after safety studies have been concluded, or
• when higher levels need to be qualified and existing data from safety studies are not sufficient for qualification.

The objectives of this related webinar are:

• explaining the main new elements in the updated reflection paper,
• addressing questions and requests for clarification received from stakeholders regarding the draft reflection paper.

The webinar is intended for all interested stakeholders with expertise and/or interest in the safety qualification of impurities.