No, I don't believe he is wrong.
CHM would advise MHRA of their findings and then MHRA would take the next step in the process. CHM advises MHRA, not the sponsor.
What Happens After Negative (or Adverse) CHM AdviceIf the CHM's final advice is negative — meaning it advises against granting the marketing authorisation — the MHRA will proceed to refuse the MAA. Key points from official MHRA guidance include:The MHRA will only refuse an application after receiving the final advice from the CHM (except in cases of technical incompleteness or failure to respond to an RFI within required timeframes).
The applicant receives a refusal letter detailing the grounds for refusal.
The decision is based on the assessment that safety, quality, or efficacy have not been adequately demonstrated, or the overall risk-benefit balance is not positive.
Appeal/Review RightsThe applicant has the right to request a review (appeal) of the refusal decision. This is set out in:Schedule 5 and paragraph 11 of Schedule 11 to the Human Medicines Regulations 2012 (as amended).
The refusal letter from the MHRA will detail the appeal process and timelines.
This may involve further representations to the CHM or other steps.
In summary, negative CHM advice is a critical step that almost invariably leads to refusal of the MAA by the MHRA, but applicants have formal appeal rights to challenge the outcome.
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