Transcription of Q12 Step 5 Technical and regulatory considerations for ...
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Q12 Step 5 Technical and regulatory considerations for ...
Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. 04 March 2020 EMA/CHMP/ICH/831751/2017 Committee for Medicinal Products for Human Use ICH guideline Q12 on Technical and regulatory considerations for pharmaceutical product lifecycle management - annexes Step 5 Transmission to CHMP 14 December 2017 Adoption by CHMP for release for consultation 14 December 2017 Start of consultation 14 December 2017 End of consultation (deadline for comments) 14 December 2018 Final adoption by CHMP 30 January 2020 Date for coming into effect* See below* *refer to the Note on EU implementation of ICH Q12 (EMA/CHMP/ICH/78332/2020) for further details.
− EC: The impact of particle size distribution (PSD) of API on blend homogeneity and dissolution could not be excluded during development. PSD was not studied outside the range of 20-50 um; this range is an EC. − Reporting: The impact of a change outside this range on blend homogeneity and
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