In 2016, the European Medicines Agency (EMA) announced the publication of a draft guidance on the dissolution requirements for orally administered generics with immediate release characteristics. The draft paper defined immediate release as a product where at least 75% of the active substance is dissolved within 45 minutes (derived from the Ph. Eur. recommendation for conventional release dosage forms).
This week, the EMA finalized the reflection paper for generic solid oral immediate release products with systemic action. Many companies had input into the text during a 3 month consultation period, including AstraZeneca, Bayer and Sanofi.
It must be noted however, that this paper is not intended as a formal guideline but instead as a discussion on the suitability of the dissolution method and the specifications for in vitro dissolution; the overall aim being to ensure batch-to-batch consistency and the detection of potential problems with bioavailability in vivo.
Click here to access the full CHMP Reflection Paper