ICH guideline Q1A is a stability guideline that reached Step 4 in 1993 and was established as one of the first guidelines finalized by the ICH. ICH guideline Q5C is a stability guideline for biopharmaceuticals that reached Step 4 in 1995. Since the establishment of the guidelines, various experiences on stability have been accumulated by both industry and regulatory authorities, and concepts such as control strategy (ICH Q8/11), quality risk management (ICH Q9), and life cycle approach (ICH Q10/12) have been proposed. Against these backgrounds, Q1/Q5C revision is required to harmonize the existing stability guidelines Q1/Q5C by incorporating science- and risk-based approaches and establishing a single integrated guideline. In addition, stability modeling is considered to be one of the ways to enable early patient access to medicines by predicting retest date and shelf-life. In this session, the draft concept paper on the revision of ICH guideline Q1/Q5C will be explained and case studies on stability modeling for biopharmaceuticals will be presented.
Key Questions: 1. Is there any expectation to ICH Q1/Q5C revision in terms of stability study programs, retest date and shelf-life from the viewpoint of regulator and industry? 2. What are the challenges and expectation to predict stability profile, set retest date and shelf-life by using stability modeling? 3. Are there any cases where different shelf-lives are approved for different countries, though the same stability data package is provided? 4. Are there any cases of approved products with stability testing or shelf-life utilizing prior/platform knowledge? 5. In accelerated and early access programs (e.g., Sakigake Designation, FDA BTD, EMA PRIME), what approaches can be used for stability testing and shelf-life setting?
Session Speakers: 14:05 - 14:25 Topics Regarding Revisions of ICH Q1/Q5C Guidelines: Focus on Biological Products Takashi Kameda, PMDA-Pharmaceuticals and Medical Devices Agency, Japan
14:25 - 14:45 Targeted Revision of ICH Q1s/Q5C - Opportunities with Science and Risk-based Approaches Boris Zimmermann, Genentech, a Member of the Roche Group, United States
14:45 - 15:05 Using Stability Prior-knowledge from 'Like-molecules' to Determine Shelf-life Andrew Lennard, Amgen Limited, United Kingdom