Government response to 3 ACMD reports (accessible)
Published 23 February 2026
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Sarah Jones MP
Minister of State for Policing and Crime
2 Marsham Street
London SW1P 4DF
Professor David Wood
Chair, Advisory Council on the Misuse of Drugs (ACMD)
Professor Roger Knaggs
Chair, ACMD Technical Committee
C/o ACMD Secretariat
1st Floor, Peel Building
2 Marsham Street
London, SW1P 4DF
By e-mail only: ACMD@homeoffice.gov.uk
18 February 2026
Dear Professor Wood and Professor Knaggs,
Advisory Council on the Misuse of Drugs’ (ACMD) advice on: i) somapacitan, lonapegsomatropin, and somatrogon, ii) zuranolone, and iii) ganaxolone.
I am grateful to the ACMD for producing three reports, as requested by the Medicines and Healthcare products Regulatory Agency (MHRA), which you published on 13 August. These reports concern five new medicines on the market, all of which have been granted marketing authorisations by the MHRA. The reports set out the ACMD’s views and recommendations on whether the medicines should be controlled under the Misuse of Drugs Act 1971 and scheduled under the Misuse of Drugs Regulations 2001.
I have set out the recommendations from each report followed by the government’s overall response.
ACMD advice on the classification and scheduling of somapacitan, lonapegsomatropin, and somatrogon
Recommendation 1
The ACMD recommends that somapacitan, lonapegsomatropin, and somatrogon should be controlled as Class C drugs under the Misuse of Drugs Act 1971.
Lead department
The Home Office.
Measure of implementation
Legislative changes to the Misuse of Drugs Act 1971.
Scheduling
The three growth hormone medicines already listed in the Misuse of Drugs Regulations 2001, somatotropin, somatropin, and somatrem, are currently scheduled under Schedule 4 (Part 2) of the Misuse of Drugs Regulations 2001.
Recommendation 2
The ACMD recommends that somapacitan, lonapegsomatropin, and somatrogon should each be scheduled under Schedule 4 (Part 2) of the Misuse of Drugs Regulations 2001.
Lead department
The Home Office.
Measure of impact
Legislative changes to the Misuse of Drugs Regulations 2001 (as amended).
ACMD advice on the classification and schedule of zuranolone
Recommendation 1
The ACMD recommends that zuranolone should be controlled as a Class C drug under the Misuse of Drugs Act 1971.
Lead department
The Home Office.
Measure of implementation
Legislative change to the Misuse of Drugs Act 1971.
Recommendation 2
The ACMD recommends that zuranolone should be scheduled under Schedule 4 (Part 1) of the Misuse of Drugs Regulations 2001.
Lead department
The Home Office.
Measure of impact
Legislative change to the Misuse of Drugs Regulations 2001 (as amended).
ACMD advice on ganaxolone
Recommendation 1
The ACMD recommends that ganaxolone should not be controlled under the Misuse of Drugs Act 1971 nor scheduled under the Misuse of Drugs Regulations 2001 at this time.
Recommendation 2
The ACMD recommends that the MHRA incorporate consideration of misuse, abuse and diversion into their risk management plan for ganaxolone, and that the MHRA, in collaboration with the licence holder, monitor misuse in their post-marketing surveillance. If the surveillance shows evidence of misuse, the MHRA should resubmit evidence to the ACMD for further consideration.
Lead department
MHRA
Measure of implementation
Monitoring of misuse in post-marketing surveillance report and risk management plan, and resubmission of evidence to the ACMD if misuse is reported.
Government response
The government accepts the ACMD’s recommendations in relation to the classification and scheduling of the five medicines featured in the ACMD’s reports (in the case of ganaxolone, the recommendation not to classify or schedule).
The potential for misuse of ganaxolone is discussed in the ganaxolone Risk Management Plan assessed by the MHRA as part of the marketing authorisation application. Abuse, misuse and diversion will be monitored in line with standard pharmacovigilance practices by the MHRA and licence holder and the ACMD consulted if any potential signals of concern arise in the postmarketing setting.
I am very grateful for the expert advice provided by the ACMD in each of these three reports, and the government will act as quickly as parliamentary processes allow to control and schedule these substances.
Very best wishes,
Sarah Jones MP
Minister of State for Policing and Crime