The proposed new quality guideline shall
- harmonise CM-related definitions
- articulate key scientific approaches for CM, and
- harmonise regulatory concepts and expectations for CM across the regions.
According to the published business plan, the objectives of ICH Q13 are to
- capture key technical and regulatory considerations including certain CGMP elements specific to CM
- allow drug manufacturers to employ flexible approaches to develop, implement, or integrate CM for the manufacture of small molecules and therapeutic proteins for new and existing products, and
- provide guidance to industry and regulatory agencies regarding regulatory expectations on the development, implementation, and assessment of CM technologies.
An Expert Working Group with 35 experts has set a time frame from November 2018 – November 2021, to reach Step 4 of the ICH process. A step 2b document can be expected in June 2020.
ICH Q 13: Business Plan and Concept Paper