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Re: beartrap12 post# 692459

Saturday, 05/18/2024 1:30:24 PM

Saturday, May 18, 2024 1:30:24 PM

Post# of 699219
A slight distinction: It's my understanding from reading about the CHM on the UK.Gov site, that they act in an advisory roll only. They can recommend approval, but the approval still rests with MHRA.
From the site:

The Commission on Human Medicines was established in October 2005. Its functions are set out in regulation 10 of the Human Medicines Regulations 2012 (SI 2012/1916).

Our responsibilities
We’re responsible for:

advising on applications for both national and European marketing authorisations
considering further representation against our provisional advice in respect of national applications
advising on the need for, and content of, risk management plans for new medicines
advising on the impact of new safety issues on the balance of risks and benefits of licensed medicines - eg adding warnings, restricting or suspending use of a medicine
advising the licensing authority on changes to legal status of marketing authorisations



And from ChatGBT:

In the UK, the Commission on Human Medicines (CHM) is responsible for advising the Medicines and Healthcare products Regulatory Agency (MHRA) on matters relating to the safety, efficacy, and quality of medicines. One of the key responsibilities of the CHM is to make recommendations regarding Marketing Authorisation Applications (MAAs) for new medicines.

The CHM does hold regular meetings, typically on a monthly basis, where they discuss various issues, including the assessment of MAAs. During these meetings, the CHM reviews detailed reports and data on new medicines to determine whether they meet the necessary standards for approval. Their recommendations are then considered by the MHRA, which makes the final decision on whether to grant a marketing authorisation.

Thus, the CHM plays a crucial role in the decision-making process for MAAs during their monthly meetings by providing expert advice and recommendations based on their evaluations of the medicines in question.


I only mention this to try to dispel any false hopes tied to a specific meeting date of the CHM. CHM may well recommend approval to MHRA in their meeting later this month, but that does not mean MHRA will approve on that very day or even the next week. However, we are closer than we were yesterday.
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