August 2022
Real CMC Tips and Insights

published 16 Sep 2022

Since the beginning of July 2020, we have published weekly Regulatory tips and insights from our Regulatory experts on our Real Regulatory LinkedIn page, as a service to our followers. The tips we published in August 2022 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.



For solid oral dosage forms, biowaivers for additional strengths are possible if the qualitative composition and manufacturing process are the same, the strengths are quantitatively proportional (excluding coating components, capsule shells, colours and flavours), and supportive in vitro dissolution data are available. If the drug substance constitutes less than 5% of tablet core weight, some deviation from quantitative proportionality is permitted. Each layer of bilayer tablets is considered independently. Fixed combinations are more complicated, therefore detailed worked examples have been provided by the PKWP in Q&A 6.4.






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