Clinical Compliance
ICH E6(R3) Gap Assessment & Advisory
ICH E6(R3) introduces new expectations for risk-based quality management, sponsor oversight, and investigational product supply chain control. Vitalane helps sponsors and CROs understand where their current systems fall short — and what to do about it.
Why ICH E6(R3) Requires Active Attention
The updated GCP standard is not a cosmetic revision. Sponsors who have not assessed their systems against E6(R3) are operating with an unknown compliance gap.
E6(R3) is not a minor update
ICH E6(R3) restructures the GCP guideline and introduces new expectations for risk-based quality management, sponsor oversight of outsourced activities, and investigational product supply chain control. Systems built around E6(R2) will have gaps.
Regulators are already applying E6(R3) expectations
TGA, FDA, and EMA inspectors are increasingly referencing E6(R3) principles in clinical trial inspections. Sponsors who have not assessed their systems against the updated standard are at risk of findings they could have anticipated.
Sponsor accountability for outsourced clinical operations
E6(R3) reinforces that sponsors remain accountable for the quality of all outsourced clinical activities — including those delegated to CROs. Independent advisory helps sponsors understand where their oversight obligations begin and end.
Delivered by Bright Gnanaselvam directly
Every E6(R3) engagement is conducted by Bright — not delegated to a junior associate. Clients work directly with the practitioner from gap assessment through to remediation support.
What the Engagement Covers
Scope is agreed based on your organisation's current GCP systems, trial portfolio, and regulatory exposure. Engagements can cover the full E6(R3) standard or focus on specific areas of concern.
Conducted by Bright Gnanaselvam — MSc Pharmaceutical Sciences, MRSC — directly.
- Gap assessment of current GCP systems against ICH E6(R3)
- Risk-prioritised remediation roadmap
- SOP gap analysis and update recommendations
- Quality Management System (QMS) review against E6(R3) principles
- Risk-based monitoring framework review
- Investigational product supply chain compliance review
- Trial Master File (TMF) structure assessment
- Advisory support through remediation and implementation
Common Questions
What changed in ICH E6(R3) compared to E6(R2)?
ICH E6(R3) restructures the GCP guideline into two parts: a set of overarching principles and annexes for specific trial types. Key changes include a stronger emphasis on risk-based approaches to quality management, updated requirements for investigational product supply chain oversight, revised trial master file expectations, and clearer accountability for sponsors managing outsourced clinical operations.
Who needs an ICH E6(R3) gap assessment?
Any sponsor or CRO that conducts or manages clinical trials should assess their current GCP systems against E6(R3). This includes sponsors with existing SOPs and quality management systems built around E6(R2), organisations preparing for regulatory inspections, and companies entering new markets where E6(R3) adoption is expected by the local regulator.
Does ICH E6(R3) affect investigational product supply chain requirements?
Yes. ICH E6(R3) includes updated requirements for investigational product (IP) supply chain management, including accountability, storage, handling, and return or destruction. Sponsors who outsource IP manufacturing, packaging, or distribution need to ensure their quality agreements and oversight processes reflect the updated standard.
Assess Your E6(R3) Readiness
Book a short call with Bright to discuss your current GCP systems and where E6(R3) is most likely to create gaps.