ICH advances guidelines on selective reporting of safety data, viral safety
The International Council for Harmonisation (ICH) recently announced the adoption of its E19 guideline, which outlines a risk-based approach for collecting safety data for late-stage pre-approval or post-approval studies when the safety of a drug is well-understood.In a separate development, ICH announced that its draft Q5A(R2) guideline on analytical testing of biotechnological products to ensure product safety has been released for consultation.
ICH E19 describes conditions for reduced data collection
The ICH E19 guideline provides internationally harmonized guidance on when it is appropriate to reduce the collection of safety data in pre-approval and post-approval clinical trials, with agreement from regulatory authorities.
“In specific phase 3 or post-approval clinical trials, if the safety profile of a drug is well-understood and documented, collection of comprehensive safety data may provide only limited additional knowledge of clinical importance,” states the guideline. “In such circumstances, a more selective approach to safety data collection may be adequate.”
The guideline covers the types of data for which selective data collection may be appropriate, circumstances for when selective safety data collection may be considered, and methods for implementing this data collection method.
The final guideline is a wholesale rewrite of the 2019 version; it contains a new section addressing the safety of trial participants, and a new section on factors contributing to a conclusion that the safety profile of a drug is sufficiently characterized to justify reduced safety data collection.
The section on the data that should be collected for reduced data collection and the section offering examples of where selection safety data collection may be considered has also been revised. (RELATED: FDA Seeks Comment on ICH Guideline on Optimizing Safety Data Collection, Regulatory Focus 16 July 2019)
The name of the guidance has also been revised from “Optimisation of Safety Data Collection” to “A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials.”
ICH points out that patient care should not be compromised when using selective data collection approaches.
Viral safety guideline now at consultation stage
Separately, ICH has announced its Q5A(R2) guideline that sets harmonized scientific and technical requirements for testing the viral safety of biotechnology products has reached Step 2 of the ICH process.
The guidance notes that virus contamination of biotechnology products may emanate from two sources, either the original cell line or from introducing the virus during production processes. It states that “an important part of qualifying a cell line for use in the production of a biotechnology product is the appropriate testing for the presence of viruses.”
The 63-page guidance covers cell line qualification and testing for viruses, testing for viruses in unprocessed bulk, the rationale and action plan for viral clearance studies and virus test on purified bulk, evaluating and characterizing viral clearance procedures, and points to consider for continuous manufacturing processes.
The guideline covers products that are amenable to viral clearance studies such as genetically engineered viral vectors and viral vector derived products, viral vectors where a helper virus is not required and viral vector derived products such as virus-like particles (VLPs), protein subunits and nanoparticle-based vaccines and therapeutics.
The guideline encourages the use of alternative tests, such as Next Generation Sequencing (NGS) and Polymerase Chain Reaction (PCR) which aligns with global initiatives and reduces the reliance on animal tests.
The guideline offers specific examples of how virus selection may be informed based on prior knowledge.
The ICH Working Group anticipates that the guideline will be signed off in November 2023.
ICH E19 guideline
ICH Q5A(R2)
ICH Q5A(R2) Presentation
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