Here is what Grok3 has to say on the subject.
This suggests that CHM is likely to be involved for possibly positive or negative reasons, but likely to be involved.
Does the MHRA refer all MAA recommendations to the CHM both positive and negative?
The Medicines and Healthcare products Regulatory Agency (MHRA) does not refer all Marketing Authorisation Application (MAA) recommendations to the Commission on Human Medicines (CHM) for both positive and negative outcomes. The referral process depends on specific circumstances outlined in the MHRA’s guidance and procedures. Here's a detailed explanation based on available information:
Positive Recommendations: The MHRA typically does not refer all positive MAA recommendations to the CHM. If the MHRA’s assessment concludes that the application meets the necessary quality, safety, and efficacy requirements and the risk-benefit balance is positive, the application may proceed to approval without mandatory CHM consultation. However, the MHRA may consult the CHM or its Expert Advisory Groups (EAGs) during the assessment process for complex or innovative applications (e.g., new active substances, biosimilars, or applications for conditional or exceptional circumstances authorisations) to seek advice on quality, safety, or efficacy. This is particularly common during the initial assessment phase (up to Day 90) or for applications under the rolling review or 150-day assessment processes. If the application is straightforward and approvable after resolving any issues (e.g., through responses to Requests for Further Information (RFIs)), the MHRA can grant the authorisation without further CHM involvement.
Negative Recommendations: The MHRA is more likely to refer an MAA to the CHM when it proposes to refuse the application, particularly if there are unresolved major objections or deficiencies that present a potential serious risk to public health. For example, if safety, quality, or efficacy concerns remain after the applicant’s responses to RFIs, or if no response is received within the specified timeline (e.g., 60 days for established medicines), the MHRA may refer the application to the CHM for advice on refusal. In such cases, the CHM provides a provisional opinion, and the applicant receives a letter outlining the reasons for potential refusal. The applicant then has the opportunity to make written or oral representations to the CHM. The CHM’s final advice informs the MHRA’s decision to grant or refuse the MAA.
Specific Scenarios:
For applications under the International Recognition Procedure (IRP), if major objections persist at Day 110, the MHRA seeks formal advice from the CHM on approvability, reverting to the standard 210-day national procedure timetable.
For established medicines, if deficiencies are considered to pose a serious public health risk or if no response is received within 60 days of an RFI, the MHRA refers the application to the CHM for advice on refusal.
For Article 29 referrals (related to mutual recognition or decentralised procedures), the MHRA may adopt the CHMP or CMDh opinion (positive or negative) unless UK-specific changes are needed, but this applies specifically to Northern Ireland until 31 December 2024, and from 1 January 2025 for UK-wide applications under certain conditions.
Exceptions and Context: The MHRA’s decision to consult the CHM depends on the complexity of the application, the nature of the medicinal product (e.g., new active substances, biologics, or advanced therapies), and whether significant issues arise during the assessment. For instance, applications for conditional marketing authorisations (CMAs) or exceptional circumstances MAs may involve CHM consultation to assess eligibility or unresolved issues, but this is not automatic for all positive recommendations. The CHM’s role is advisory, and the MHRA makes the final decision, considering CHM advice when it is sought.
In summary, the MHRA refers MAA recommendations to the CHM primarily when there are significant concerns (e.g., potential refusal due to safety, quality, or efficacy issues) or for complex applications requiring expert input. Positive recommendations may not always require CHM referral unless specific issues or complexities arise during the assessment process. For the most accurate and up-to-date guidance, applicants should refer to the MHRA’s official website or contact RIS.NA@mhra.gov.uk for clarification.
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