About us
The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products.
Who we are
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
Terms of reference
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).
The functions of the Commission on Human Medicines are:
- to advise the Health Ministers and the Licensing Authority (LA) on matters relating to human medicinal products including giving advice on the safety, quality and efficacy of human medicinal products where either the Commission thinks it appropriate or where it is asked to do so
- to consider those applications that lead to LA action as appropriate (eg where the LA has a statutory duty to refer or chooses to do so)
- to consider representations made (either in writing or at a hearing) by an applicant or by a licence or marketing authorisation holder in certain circumstances
- to promote the collection and investigation of information about adverse reactions to human medicines so advice can be given
The Commission is similarly involved in respect of medicinal products to which relevant EC legislation applies.
The Code of Practice
Code of Practice on conflicts of interest applies to chairs, members, co-opted members and invited and patient experts of all our scientific advisory committees. See Code of Practice.
The principles in the Code also apply to observers and invited experts who are asked to contribute written advice and do not attend committee meetings.