HRT provider censured by UK regulator for ‘systemic failures’ that put patients at risk | Health
One of the biggest manufacturers of hormone replacement therapy has been condemned by regulators for “systemic failures” that endangered patient safety.
Theramex, UK manufacturer of HRT drugs Evorel and Intrarosa, was found to be in breach core compliance standards This includes not updating important prescribing information for several years in some cases and not clearly stating that a medicine should not be used during pregnancy.
The Prescription Medicines Code of Practice Authority (PMCPA), the UK pharmaceutical industry’s self-regulatory body, issued a public reprimand against Theramex after its own staff reported “alarming” compliance issues and missing prescribing information for Evorel and Intrarosa that “compromised patient safety”.
Evorel patches containing estradiol are among the most prescribed forms of transdermal HRT, with more than 250,000 products issued in the last financial year. NHS Business Services Authority figures. Overall, around 10 million estradiol substances, including gels, were prescribed in the 2024/25 financial year.
employee concerns This includes Evorel’s prescribing information not providing comprehensive side effect information and Intrarosa’s product information not having been updated since 2019.
PMCPA also condemned the company failures to indicate Its advertisement at a reproductive and advertising conference stated that Yselty (linzagolix), used to treat uterine fibroids, should not be taken during pregnancy.
In total, the PMCPA found Theramex breached the Association of the British Pharmaceutical Industry (ABPI) code of practice 21 times.
The panel said these violations not only jeopardized patient safety, Theramex “brought into disrepute and diminished trust in the pharmaceutical industry.”
The PMCPA also condemned Theramex’s decision to leave the regulatory authority’s jurisdiction. “By abandoning its self-regulatory framework and requiring the Medicines and Healthcare products Regulatory Agency (MHRA) to take full responsibility for regulating it, Theramex has inevitably delayed any regulatory action and oversight,” he said.
ABPI’s medical director, Dr. Amit Aggarwal said: “[Theramex] It has fallen seriously short of the standards expected under our strict ABPI code of practice and it is right that the PMCPA takes action.
“As a result, it is also disappointing that the company has decided to leave the pharmaceutical industry’s self-regulatory system, which holds companies to standards above and beyond the law.”
Julian Beach, the MHRA’s chief executive of healthcare quality and access, said he was disappointed to see Theramex leave the PMCPA but the MHRA would take whatever steps necessary to ensure patient safety.
“Leaving the PMCPA’s jurisdiction does not mean that a company will escape scrutiny. MHRA legal powers …to investigate and take action on concerns about medications that may affect public safety. “Breaking the regulations may constitute a criminal offence.”
A spokesperson for Theramex said: “Maintaining ethical standards, compliance and patient safety are very important to us. We took immediate action upon learning of these historic matters.
“We take these matters seriously and have undertaken a comprehensive review of our compliance framework, including commissioning an independent external audit and implementing a broad remediation programme.
“As part of this process, we have concluded that it is most appropriate to be regulated by the MHRA in accordance with UK medicines legislation, whilst continuing to uphold the spirit and principles of the EFPIA. [European Federation of Pharmaceutical Industries and Associations] and ABPI codes of practice.
“Therefore, we withdrew from the jurisdiction of the PMCPA in January 2026. This approach allows us to focus our resources on maintaining high standards of ethical and compliant conduct while prioritizing patient safety.”
