The purpose of this presentation is to detail the current EU regulatory framework and guidance surrounding the identification, control and risk assessment of extractables and leachables in medicinal products. It will provide a regulatory assessor perspective and outline the data expectations for different types of products. Although strict limits are not set out in guidance documents, a risk based approach is followed and products are generally assessed on a case by case basis. The presentation will also provide some examples of deficiencies noted in assessments of national and EU marketing authorisation applications and variations.
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