Manufacture has to demonstrate that its product is essentially similar to reference product (same efficacy, safety and quality), which is usually done by bioequivalence studies.
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Akanksha Nagpal
Aachen
Germany
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Original Message:
Sent: 20-Apr-2018 15:35
From: Xueling Shen
Subject: Comparison Studies for Generic Injectable
For a Generic Injectable submission using DCP in EU, does the manufacturer have to purchase Reference product from the RMS and conduct some sort of comparison studies on Physical chemical in order to generate some data for ? Assume the formulation is same and no clinical study is required.