Inspectors do not announce their priorities in advance, but they do publish the rules they will be applying. The guidance changes of 2026, taken together, point quite clearly toward where inspection attention is likely to concentrate in 2027. A revised EU pharmacovigilance inspection guideline, a new mandatory FDA safety data standard, a rewrite of EU GMP computerised systems and documentation rules, and a new UK clinical trials framework all arrived or advanced within the same twelve months.
This article sets out five predictions. To be clear, these are informed expectations drawn from published guidance and work plans, not statements from any regulator, and some depend on documents that are still in draft. Each prediction is paired with what to do about it. If you are searching for MHRA and EMA inspection trends 2027, pharmacovigilance inspection readiness, GMP data integrity priorities, or regulatory compliance planning for 2027, this is written for you.
Prediction 1: Vendor and Subcontractor Oversight Becomes a Headline Theme
What the guidance says: Revision 2 of GVP Module III, in force since 10 September 2026, states that inspections cover not only the marketing authorisation holder but also third parties subcontracted for pharmacovigilance tasks and their subcontractors. The third party has an obligation, set out in the subcontract, to agree to be inspected. The module also lists the extent and number of third parties involved, changes of QPPV, changes of safety database and changes to contractual arrangements among the factors that raise inspection risk.
Why this suggests 2027 focus: Once inspectors have the explicit power and a clear checklist, they tend to use it. Expect more questions that start with the vendor contract and end with the evidence that the MAH actually oversees what it has delegated.
What inspectors are likely to ask for:
- A complete map of subcontracted activities, including sub-vendors
- Contracts with explicit inspection and audit rights
- Evidence of vendor oversight, such as audits, performance metrics and meeting records
- Proof that the QPPV can access the data and the people behind each delegated task
How to prepare: Audit your vendors against your own contract, not just against a generic questionnaire, and keep the results where the QPPV can find them in minutes.
Prediction 2: Computerised Systems and Data Governance Face Sharper Scrutiny
What the guidance says: The draft revision of EU GMP Annex 11 grows from a few pages to a much longer text and moves toward prescriptive requirements on security, identity and access management and audit trail control. The revised Chapter 4 treats electronic records, hybrid systems and metadata as explicit subjects of control. EMA’s GMP and GDP Inspectors Working Group has targeted Q4 2026 for handing final texts to the European Commission, and its current work plan includes training for EU GMP inspectors on the revised Chapter 4, Annex 11 and Annex 22 across 2026 to 2028.
Why this suggests 2027 focus: Inspector training is scheduled in advance of, and alongside, the new rules. Even if application dates fall later because of transition periods, inspectors who have been trained will bring the expectations into conversations about data governance well before the legal date.
What inspectors are likely to ask for:
- Evidence that user access is reviewed and that shared accounts do not exist
- Documented, risk-based audit trail review as part of batch and result review
- Supplier assessments and periodic reviews for cloud and software-as-a-service tools
- Data flow maps showing where critical data is created, processed and archived
How to prepare: Run a gap assessment against the draft texts now, then update it when final versions appear.
Prediction 3: E2B(R3) Data Quality Becomes a Pharmacovigilance Inspection Topic
What the guidance says: Since 1 October 2026, FDA requires postmarketing ICSRs to be submitted in the E2B(R3) format. FDA’s position is that once a company starts using R3, all its submissions are expected to use it. R3 is more structured and validates more strictly than R2.
Why this suggests 2027 focus: Every migration leaves a trail of validation records, reconciliations, rejected messages and backlog decisions. Inspectors in pharmacovigilance routinely examine ICSR timeliness, completeness and the fitness for purpose of computerised systems, all of which are directly affected by a cutover. A company that migrated in a hurry is likely to have gaps that a 2027 inspection will find.
What inspectors are likely to ask for:
- Validation documentation for the safety database version and the gateway connection
- A reconciliation of cases received, processed and submitted across the cutover
- Analysis of rejections and how root causes were fixed
- Evidence that partners and vendors reported correctly, with clear responsibilities in agreements
How to prepare: Treat the migration as a validated change and close the documentation loop while the details are still fresh.
Prediction 4: Change Becomes a Trigger for Inspection
What the guidance says: GVP Module III lists organisational change, such as mergers and acquisitions, a change of QPPV, a change of safety database and the transfer of PSMF management among the risk factors used to plan inspections. It also confirms that for-cause inspections can follow delays in corrective actions or information from other inspections.
Why this suggests 2027 focus: Many companies made significant changes in 2026 to meet new requirements, such as new safety databases, new vendors and new QPPV arrangements. Those very changes are signals that planners can use to prioritise inspections, and they sit on top of an inspection cycle that is risk based by design.
What inspectors are likely to ask for:
- A change history for the pharmacovigilance system, with the reasons and risk assessments for each change
- Evidence that the PSMF reflects the current state of the system
- Proof that transition periods were managed without gaps in reporting or oversight
How to prepare: Keep a single change log for the system, record the impact assessment for each entry, and update the PSMF at the time of each change rather than at the next review.
Prediction 5: Artificial Intelligence Moves From Curiosity to Inspection Question
What the guidance says: The draft Annex 22 would be the first EU GMP annex dedicated to artificial intelligence. Its approach centres on a clearly defined intended use, validation against predefined acceptance criteria, transparency of decision logic, ongoing performance monitoring and change control, and human accountability for final decisions. Separately, the MHRA has launched a regulatory AI sandbox focused on medicine safety, and EMA has signalled that pharmacovigilance is part of its wider thinking about data, real-world evidence and pharmacogenomics.
Why this suggests 2027 focus: Companies are already using AI tools for case intake, literature screening, coding and document drafting. Once inspectors have a framework for assessing them, even in draft, they are likely to start asking how those tools are controlled.
What inspectors are likely to ask for:
- An inventory of AI and machine learning tools used in GxP and pharmacovigilance processes
- The documented intended use of each tool and the validation evidence behind it
- Proof that a qualified person reviews outputs and remains accountable for decisions
- Monitoring and change control records showing performance over time
How to prepare: Start the inventory now, write down the intended use and the level of human oversight for each tool, and do not allow unvalidated tools to touch decisions that affect patient safety or product quality.
The UK Backdrop: More Change Than Usual
A few UK developments add to the picture. New UK Clinical Trials Regulations came into effect on 28 April 2026, and MHRA guidance on serious breaches and investigator responsibilities has been updated to match. Regulatory reform amendments have been tabled in the Government’s Health Bill, and the MHRA has been consulting on fees for 2027. These do not point to a single inspection theme, but they do mean that UK-based companies are operating in a period of unusual regulatory movement, and that records of how changes were assessed and implemented will carry weight.
Practical Steps to Take Before the New Year
- Build one regulatory change register covering pharmacovigilance, GMP and GDP, with owners and review dates
- Audit your pharmacovigilance and quality vendors against the new inspection expectations
- Run an unannounced mock inspection that includes at least one vendor and one computerised system
- Inventory every AI tool in use, with intended use, validation status and human oversight arrangements
- Document the validation and reconciliation evidence for any system migration completed in 2026
- Update the PSMF and your change log so that they match reality today
Preparing Now for the 2027 Inspection Cycle
Predictions are only useful if they change what you do. Quality and Vigilance Ltd supports companies in preparing for the inspection themes most likely to matter next year, alongside its core pharmacovigilance and regulatory affairs services covering the MHRA, EMA and FDA. Acting before the first inspection notice arrives gives you time to find and fix problems on your own terms. The most practical support usually includes:
- Vendor oversight reviews and contract updates that reflect the new subcontractor inspection provisions
- Computerised system and data integrity gap assessments aligned to the draft Annex 11 and Chapter 4
- E2B(R3) post-migration reviews that reconcile data and confirm timelines were met
- Change management and PSMF reviews that give inspectors a clear and current picture of your system
- Governance frameworks for AI tools used in pharmacovigilance and quality processes
Get in touch with Quality and Vigilance Ltd today to prepare for the 2027 inspection cycle while there is still time to act.