EMA - Consultation on ICH Guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b

17th August 2021

The European Medicines Agency has published for public consultation the ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b.

This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing ICH Quality guidelines, this guideline provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products.

Comments should be provided using this  template and sent to ich@ema.europa.eu by 20 December 2021.

The EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public and targeted consultations.

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