The EPR regulatory roundup: 9–13 November 2026

Welcome to this week’s Regulatory Roundup, covering the latest regulatory updates from around the world. This week, developments include new Innovation Passports through the MHRA’s Innovative Licensing and Access Pathway, updated FDA safety labelling requirements for GLP-1 medicines, and further findings on GMP compliance.

MHRA awards three Innovation Passports and opens new ILAP round

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has awarded three investigational medicines Innovation Passports through its Innovative Licensing and Access Pathway (ILAP). The therapies target Huntington’s disease, non-small cell lung cancer and Alzheimer’s disease, and will receive coordinated support throughout development from the regulator, NHS and health technology assessment bodies. The ILAP is designed to accelerate the development of transformative medicines and drug-device combinations, bringing developers together with regulatory and health system partners. The MHRA has also opened the next application round for Innovation Passports, with submissions accepted until 11 February 2027.

FDA requires new eye-risk warnings for GLP-1 RA medicines

The US Food and Drug Administration (FDA) is requiring application holders of all glucagon-like peptide-1 receptor agonist (GLP-1 RA) medicines to update product labelling to include a warning about the potential increased risk of non-arteritic anterior ischaemic optic neuropathy (NAION). Announced on 9 November, the requirement follows the FDA’s review of clinical trial data, animal studies, post-marketing data and observational research. NAION is a rare condition caused by reduced blood flow to the optic nerve, which can result in sudden, painless vision loss in one eye and, in some cases, permanent impairment. An FDA analysis of 126 randomised controlled trials found an incidence of 6.4 cases per 100,000 person-years among patients receiving GLP-1 medicines, compared with 3.8 cases per 100,000 person-years in comparator groups. The agency is requiring the risk information to be added to the Warnings and Precautions section of product labelling across the GLP-1 RA class.

MHRA approves retifanlimab for advanced anal cancer

The MHRA has approved retifanlimab (ZYNYZ) for adults with squamous cell carcinoma of the anal canal that cannot be removed surgically and is metastatic or has returned locally. The approval was granted to Incyte Biosciences UK Ltd. on 5 November through the International Recognition Procedure (IRP) and announced by the agency on 11 November. Retifanlimab is a PD-1 inhibitor that helps the immune system recognise and attack cancer cells, and is administered in combination with carboplatin and paclitaxel. The decision was supported by a study involving 308 people with metastatic or locally advanced disease, in which retifanlimab plus chemotherapy increased the time patients lived without their cancer worsening compared with chemotherapy alone.

FDA warning letters highlight GMP deficiencies across pharmaceutical manufacturing

The FDA has issued several warning letters identifying current good manufacturing practice (cGMP) deficiencies at pharmaceutical manufacturing facilities in India and China. Findings included weaknesses in aseptic processing operation controls, such as unidirectional airflow deficiencies, poor aseptic practices and insufficient contamination control, as well as shortcomings in critical raw materials supplier qualification and quality unit oversight. Two further warning letters to API manufacturers in China concerned failures to provide records requested by the FDA. The agency’s findings highlight the importance of robust quality systems, effective contamination control and appropriate oversight of suppliers, alongside the need for manufacturers to maintain accessible and complete records for regulatory inspection.