Breakthrough Medicines Manufacturing Q&A Issued by FDA, EMA

A newly published Q&A document from the FDA and the European Medicines Agency (EMA) outlines the similarities – and differences – in the two agencies’ requirements for manufacturing breakthrough products.

Intended for manufacturers that are submitting applications to FDA’s Breakthrough Therapy (BT) program and EMA’s Priority Medicines program (PRIME), the document provides details in four areas: control strategy, process validation, good manufacturing practice (GMP) and alternatives for determination of retest period or shelf-life.

Since both programs accept limited clinical evidence for investigational products, sponsors can establish specification acceptance criteria wider than the actual test results of the batches used in clinical studies, the document notes. In fact, “it is recognized that setting specification acceptance criteria wider than clinical experience is frequently a need specifically for PRIME/BT programs.”

Read the entire Q&A document here.

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