Description
This document describes a process for the evaluation and recommendation by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Following favorable evaluations, ICH will issue topic-specific annexes with information about these texts and their implementation (the Q4B Outcomes). Implementation of the Q4B annexes is intended to avoid redundant testing by industry.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Stakeholders
7Individual notified of the submission for awareness
Intermediary for document submission
Expert Working Group that evaluates documents for regulatory impact; Expert Working Group receiving the document submission
Entity responsible for submitting NDINs
Entity responsible for submitting applications under section 524B
Body that endorsed the S10 guidance
Evaluates selected pharmacopoeial texts for recognition
Regulatory Context
Regulatory Activities
3Regulatory mechanism for handling compendial changes
Regulatory mechanism pertaining to compendial changes
Process followed to develop topic-specific annexes
Document Types
6Chapters in pharmacopoeias providing clarifying information
Document dealing with residual differences and implementation schedules
The PDG Stage 5B sign-off document: Japanese Pharmacopoeial Forum
Submissions to the MAA regarding postapproval changes
Topic-specific document issued following the ICH process
Information about pharmacopoeial texts and their implementation
Technical Details
Testing Methods
4Study conducted to determine outcome of harmonization
General chapter discussed during ICH Q6A development
Vector safety testing should include microbiological testing such as sterility
Part of stability testing parameters
Processes
1Process to determine if pharmacopoeial text is interchangeable
Standards & References
External Standards
5Texts intended for adoption and publication
Japanese Pharmacopoeia referenced for Uniformity of Dosage Units
European Pharmacopoeia referenced for statistical process control.
United States Pharmacopeia standards for compendial drug substances; confirming conformance to the application-approved specification and USP
Member of the PDG
Specifications
2Harmonized standard for content and mass uniformity
Initially, the Q4B process will focus on evaluating the 11 General Test Chapters
ICH References (3)
Specifications for biotechnological/biological products; Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Referenced regarding specifications and solid state forms.
Evaluation and Recommendation of Pharmacopoeial Texts
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- E11A Pediatric Extrapolation
- M15 General Principles for Model-Informed Drug Development
- Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
- Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
- Rare Diseases: Considerations for the Development of Drugs and Biological Products
- Q3C Impurities: Residual Solvents_2011
- Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling: Guidance for Industry
- Q4B Annex 5: Disintegration Test General Chapter