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MHRA

John Montgomery5 min read

MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. It is an executive agency of the Department of Health and Social Care, formed in 2003 when the Medicines Control Agency and the Medical Devices Agency merged. Since Brexit it has licensed medicines for the UK market independently (Wikipedia; GOV.UK “About us”). Its stated duties include making sure products meet standards of safety, quality and efficacy, keeping the supply chain safe, and “educat[ing] the public and healthcare professionals about the risks and benefits of medicines”. It is funded by government grant-in-aid plus fees charged to industry. For families managing Atopic Dermatitis, it is the body that licenses prescribed creams such as Topical Corticosteroids and issues safety warnings about everyday eczema products.

MHRA [regulates] Topical Corticosteroids MHRA [regulates] Emollient Therapy

Herbal medicines. The MHRA also regulates traditional herbal and homeopathic remedies. It runs the Traditional Herbal Registration (THR) scheme, with advice from its Herbal Medicines Advisory Committee on the safety and quality of applications (GOV.UK “About us”). Its Medicines Borderline Section decides whether products sold as cosmetics or “natural” remedies are in fact unlicensed medicines. Its standing advice to the public is to check a “herbal” product for a Marketing Authorisation, Product Licence or THR number, or the THR logo, because this shows the MHRA has assessed it for safety and manufacturing quality (MHRA 2018a; 2018b). Its predecessor, the Medicines Control Agency, was already investigating Chinese herbalists who supplied dexamethasone-containing creams in 1999 (Keane et al., BMJ).

MHRA [regulates] Traditional Herbal Registration MHRA [regulates] Herbal and Home Remedies for Eczema

Warnings on adulterated creams. In 2018 the MHRA issued two warnings about Adulterated Herbal Creams. Its lab analysis found very potent Clobetasol Propionate plus antifungals in Yiganerjing Cream (early 2018) and in Zudaifu cream (December 2018). Both were sold in the UK as “natural” Chinese herbal treatments for eczema, psoriasis and rosacea. It also named Penny Orange Cream, supplied via a herbal clinic. The agency worked to remove the products from websites and online marketplaces and told sellers to stop. It said that selling potent steroid creams directly to the public “is illegal for good reason”, that clobetasol is contraindicated in children under 1 year, and that parents using the creams “particularly on young children and babies” should stop immediately and contact a healthcare professional. Suspected sales can be reported to Borderline_medicine@mhra.gov.uk.

MHRA [opposes] Adulterated Herbal Creams MHRA [regulates] Adulterated Herbal Creams

Emollient safety warnings. The MHRA’s Drug Safety Updates have shaped UK emollient advice for toddlers. In 2013 it warned that Aqueous Cream, which contains Sodium Lauryl Sulfate, can cause stinging, burning, itching and redness when used as a leave-on emollient, especially in children with eczema. Warnings in 2008, 2016 and 2018 covered Emollient Fire Risk: emollient residue soaked into clothing, bedding and dressings makes fabric catch fire easily. The 2018 update said this applies to paraffin-containing emollients of any paraffin percentage and cannot be ruled out for paraffin-free ones.

MHRA [opposes] Aqueous Cream MHRA [relates] Emollient Fire Risk Sodium Lauryl Sulfate [part-of] Aqueous Cream

Licensing update (Oct 2026). UK product information (SmPCs on emc) was checked on 3 October 2026. The MHRA products site would not render, so these findings are unconfirmed on MHRA’s own pages. Opzelura (Ruxolitinib Cream, PLGB 42338/0021, revised 11 September 2026) is licensed for moderate AD in adults only. Dupilumab is licensed for severe AD in 6 months–11 years. Ebglyss (12 years and over, at least 40 kg), Adtralza (12 years and over) and Nemluvio (12 years and over, at least 30 kg) are also listed. emc has no roflumilast cream (only Daxas and generic tablets) and no tapinarof (“No search results”). So Roflumilast Cream and Tapinarof Cream appear to be unlicensed in the UK.

MHRA [relates] Roflumilast Cream MHRA [relates] Tapinarof Cream

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