The UK Medicines and Healthcare products Regulatory Agency has published an important statement on the use of artificial intelligence when preparing responses following GxP inspections.
The MHRA confirmed that companies are already using AI tools to draft inspection responses. The regulator recognises that AI can help explain complex technical matters, improve consistency and accelerate routine drafting. However, it has also identified cases in which inappropriate AI use created real regulatory and patient-safety risks.
According to the MHRA, some AI-assisted inspection responses included references to guidance that did not exist, citations of inappropriate regulatory frameworks and inaccurate information. In one case, a response exceeded 90 pages but still failed to address the identified deficiencies. In another case involving a serious patient-safety concern, inaccurate AI-generated information increased the regulator’s review time from approximately four hours to more than 20 hours.
This is an important development because it moves the risk of AI hallucination in GxP documentation from theory into documented regulatory experience.
MHRA is not prohibiting AI
The MHRA’s position is not that companies should stop using AI. Its concern is whether information submitted to the regulator is accurate, verifiable, technically reviewed and prepared under appropriate oversight.
The regulator states that all inspection responses and related submissions must be:
- factually accurate and verifiable;
- technically reviewed by appropriately experienced personnel;
- approved by a person with sufficient authority and accountability;
- supported by evidence for factual claims;
- appropriate to the specific regulatory and organisational context.
These expectations apply regardless of whether the document was prepared using AI, templates, consultants or conventional manual drafting.
Voluntary disclosure of AI use
The MHRA is also offering companies the option to disclose when AI has been used to support an inspection response. Disclosure is currently voluntary.
Where a company chooses to disclose AI use, the MHRA recommends:
- including a brief statement at the beginning of the response;
- identifying the sections in which AI assistance was used;
- confirming that the content was verified and approved by humans.
The MHRA indicates that transparent disclosure, combined with effective verification, may demonstrate a mature and open quality culture.
This does not mean that disclosure compensates for inaccurate information. Responsibility remains with the organisation and the accountable personnel approving the response.
What may indicate inadequate AI oversight?
The MHRA identifies several warning signs that may indicate weak verification or quality-system controls:
- incorrect statements or non-existent references;
- generic language that does not address the specific deficiency;
- lack of organisation-specific information;
- citations of regulations without explaining their relevance;
- inconsistent technical terminology;
- excessively long responses that fail to address the issue clearly.
Where inspection responses are inaccurate, incomplete or unnecessarily verbose, the MHRA may reject them or return them for revision.
Weak responses may also affect the regulator’s assessment of the company’s CAPA system and future inspection risk. Serious or repeated problems may be referred for further regulatory action.
Practical implications for pharmaceutical companies
Companies using AI to prepare responses to inspections, audits or regulatory deficiencies should establish a controlled review process.
At minimum, this should include:
- use of approved regulatory and company source documents;
- verification of every cited regulation, guidance document and factual claim;
- confirmation that the response addresses the specific observation;
- technical review by subject-matter experts;
- Quality Unit review and formal approval;
- removal of generic or unsupported AI-generated statements;
- retention of evidence supporting proposed CAPAs;
- clear accountability for the final submitted response.
AI may help organise information and improve drafting efficiency, but it cannot replace root-cause analysis, technical understanding or knowledge of the company’s processes.
A well-written response that does not address the actual cause of a deficiency is not an effective CAPA response.
Key takeaway
The MHRA’s message is pragmatic and important: regulators do not need to prohibit AI to control its risks.
The regulatory expectation remains focused on outcomes. Inspection responses must be accurate, evidence-based, organisation-specific and approved by accountable personnel.
For pharmaceutical companies, this means that AI-assisted regulatory writing should be treated as a controlled quality process—not as an informal administrative shortcut.
Source:
https://mhrainspecto … stifling-innovation/
