30 September 2025
From the newsfeeds of the European Medicines Agency’s (EMA), the European Commission (EC) and the Co-ordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh) , Arex Advisor has rounded up a selection of highlights from September 2025.
EMA and WHO mark 10 years of regulatory collaboration
1 September 2025
The European Medicines Agency (EMA) and the World Health Organization (WHO) are celebrating a decade of formal cooperation to strengthen access to safe and effective medicines globally. Since the signing of a confidentiality agreement in September 2015, the partnership has focused on scientific evaluation, capacity building, and improving regulatory systems to support public health worldwide. Read more
EMA and HMA warn against illegal online sales of GLP-1 drugs
3 September 2025
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have raised concerns about the increasing spread of unauthorised medicines sold online in the EU. Authorities highlight a surge in illegal products marketed as GLP-1 receptor agonists, including semaglutide, liraglutide and tirzepatide, which are being promoted for weight loss and diabetes through fraudulent websites and social media. These medicines are not authorised and fail to meet required standards of quality, safety, and efficacy. Read more
EMA deepens collaboration with academia on scientific innovation
4 September 2025
The European Medicines Agency (EMA) is working more closely with academic partners to keep pace with scientific and technological progress. Key areas of cooperation include regulatory science research, oncology, and clinical trial development. Read more
EC: Updated FAQ on joint clinical assessments
5 September 2025
A set of frequently asked questions (FAQs) on joint clinical assessments has been published, reflecting queries received to date. The document will be updated on a regular basis. Read more
PRAC launches safety review of levamisole
5 September 2025
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has begun reviewing medicines containing levamisole, which are authorised in four EU countries for treating parasitic worm infections in both adults and children. The review was announced following the committee’s meeting held from 1–4 September 2025. Read more
EMA: 2026 deadlines for PRIME eligibility requests
10 September 2025
The European Medicines Agency (EMA) has released the 2026 submission deadlines and assessment timetable for applications to its PRIority MEdicines (PRIME) scheme. The programme is designed to support the development of medicines that address unmet medical needs. Read more
Highlights from first EMA annual bilateral meeting with ACRO
17 September 2025
The European Medicines Agency (EMA) has met with the Association of Clinical Research Organizations (ACRO) as part of its yearly series of bilateral meetings with industry stakeholders. The discussions form part of ongoing engagement between EMA and the clinical research sector. Read more
EMA: Minutes from Cancer Medicines Forum in June 2025
19 September 2025
The European Medicines Agency (EMA) has met with the Association of Clinical Research Organizations (ACRO) as part of its yearly series of bilateral meetings with industry stakeholders. The discussions form part of ongoing engagement between EMA and the clinical research sector. Read more
EMA shares Q&A recording on data management services
19 September 2025
The EMA’s regulatory data management services team has published a recording of its Q&A clinic on the Substance, Organisation, Referentials Management Services (SPOR). The session provided an opportunity for stakeholders to ask questions and receive guidance on the use of SPOR services. Read more
EMA shares Q&A recording on data management services
19 September 2025
The EMA’s regulatory data management services team has published a recording of its Q&A clinic on the Substance, Organisation, Referentials Management Services (SPOR). The session provided an opportunity for stakeholders to ask questions and receive guidance on the use of SPOR services. Read more
EMA: CHMP recommends 14 new medicines and six indication extensions
19 September 2025
At its meeting from 15–18 September 2025, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of 14 new medicines. The committee also endorsed extensions of therapeutic indications for a further six medicines. Read more
EMA: CHMP backs first treatment for IgG4-related disease
19 September 2025
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending the indication of Uplizna (inebilizumab) to include adult patients with active immunoglobulin G4-related disease (IgG4-RD). This marks the first treatment option recommended in the EU for this rare autoimmune condition. Read more
EMA publishes Q&A recording on Product Management Service
19 September 2025
The EMA has released a recording of its August 2025 Q&A clinic on the Product Management Service (PMS). The session focused on the Product User Interface (PUI) and the Application Programming Interface (API), which provide access to data on both centrally authorised and non-centrally authorised human medicines. Read more
EudraVigilance group updates Important Medical Events list
22 September 2025
The EudraVigilance Expert Working Group (EV-EWG) has developed an updated Important Medical Event (IME) list to support pharmacovigilance activities across the EU. The list is designed to guide stakeholders in classifying suspected adverse reactions, conducting case assessments, and analysing aggregated safety data, but is intended for guidance purposes only. Read more
EMA confirms current guidance on paracetamol use in pregnancy
22 September 2025
Paracetamol (acetaminophen) continues to be recommended in the EU for managing pain or fever during pregnancy when clinically necessary. Regulators note that no new evidence has emerged to warrant changes to existing guidance. Read more
EU sets new targets to boost multinational clinical trials
23 September 2025
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the EMA have agreed on two new targets to strengthen Europe’s position as a hub for clinical research. The plan includes the addition of 500 authorised multinational clinical trials over the next five years, aiming to improve Europe’s appeal for research and accelerate patient access to innovative medicines. Read more
New EU4Health calls launched under 2025 Work Programme
23 September 2025
The European Commission has granted EU marketing authorisation for Kisunla, indicated for the treatment of mild cognitive impairment and mild dementia in the early stages of Alzheimer’s disease. Read more
CMDh publishes highlights from September 2025 meeting
24 September 2025
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has released the main outcomes of its meeting held from 16–18 September 2025. Key updates include guidance on the revised variations framework, new templates and validation checklists for the decentralised procedure (DCP), criteria for SmPC harmonisation, public assessment reports under Articles 45 and 46 of the Paediatric Regulation, CMDh positions following PSUSA procedures, referral timetables for 2026, and statistics on MRP/DCP applications for the first half of 2025. Read more
EC approves Kisunla for early-stage Alzheimer’s disease
25 September 2025
The European Commission has granted EU marketing authorisation for Kisunla, indicated for the treatment of mild cognitive impairment and mild dementia in the early stages of Alzheimer’s disease. Read more
Commission reports on EU4Health action to improve healthcare access
26 September 2025
The European Commission has published a report highlighting initiatives funded through the EU4Health programme to strengthen access to healthcare across the European Union. Read more
EU and Canada strengthen cooperation on health emergency response
26 September 2025
From 22–26 September 2025, the European Commission’s Health Emergency Preparedness and Response Authority (HERA) took part in high-level events in Canada. The meetings focused on reinforcing transatlantic collaboration to improve preparedness and response to cross-border health threats and to strengthen global health security. Read more
PRAC safety signal recommendations from September meeting
29 September 2025
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has published its recommendations on safety signals reviewed during its 1–4 September 2025 meeting. The document includes an overview of the signals discussed, along with their European Pharmacovigilance Issues Tracking Tool (EPITT) reference numbers. Read more
EMA consults on draft reflection paper on patient experience data
29 September 2025
The EMA has released a draft reflection paper on the use of patient experience data in medicines regulation, now open for consultation until 31 January 2026. The paper focuses on data that capture patients’ own experiences and treatment preferences directly, without interpretation by clinicians or others. Read more
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