The facility CCS document(s) should provide an overall summary that briefly highlights the contamination controls per element and references the supporting technical documents (e.g., risk assessments, validations, qualifications and technical documents).
The draft is available via the Pharmacopeial Forum (this requires a subscription).
The document essentially draws on information in EU GMP Annex 1 and other sources, such as ‘Biocontamination Control for Pharmaceuticals and Healthcare’ (see: https://shop.elsevier.com/books/biocontamination-control-for-pharmaceuticals-and-healthcare/sandle/978-0-443-21600-8)
Microbial contamination control strategies
A related draft USP chapter has also been produced entitled ‘〈1114〉 Microbial Contamination Control Strategies for Cell Therapy Products’.
As they are living cells that cannot be terminally sterilised, cell therapy products must be manufactured under aseptic conditions. For the purposes of this chapter, cell therapy products are those products that are aseptically manufactured from autologous, allogeneic or xenogeneic cells from humans and animals that may undergo substantial manipulations (including genetic modification) outside the body before being administered to the patient.
Due to the different types of products and their associated complexities, a separate control strategy is recommended.
The draft is available via Pharmacopeial Forum (this requires a subscription).
Good clinical practice for clinical trials
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on ‘Good Clinical Practice for Clinical Trials’. The primary reason for the revision is to provide an update to the GCP inspection dossier clinical trial spreadsheet.
See: https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials#full-publication-update-history
Windsor framework
The MHRA have updated some of the required information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework. This primarily relates to updates to contact information.
See: https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines#full-publication-update-history
Modified release opioids and treatment of post-operative pain
The MHRA have provided a Safety Public Assessment Report for opioids and the treatment of post-operative pain management.
The report explains the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicine classes.
See: https://www.gov.uk/guidance/safety-public-assessment-reports#full-publication-update-history
Model informed drug development
The International Council for Harmonisation (ICH) M15 Model Informed Drug Development (MIDD) Guideline has reached Step 2b and is available for public consultation.
The ICH M15 will provide general recommendations for planning, model evaluation and documentation of evidence derived from Model-Informed Drug Development (MIDD). It establishes a harmonised assessment framework (including associated terminology) for MIDD evidence.
To access, see: https://database.ich.org/sites/default/files/ICH_M15_EWG_Step2_DraftGuideline_2024_1031.pdf
UK medical devices
The British government intends to introduce new regulations for medical devices that prioritise patient safety and provide patients access to the medical devices they need, helping to ensure the UK remains an attractive market for medical technology innovators.
The government seeks to ensure that there is a proportionate, phased approach to the implementation of the future regulatory framework, which supports system readiness and minimises the risk of supply disruption for UK patients. The regulations will be delivered though secondary legislation, including in 2025 and 2026, to introduce new pre-market requirements including international reliance.
A recent Post Market Surveillance Statutory Instrument is the first major update to the framework of medical device regulations. This draft introduces regulations on monitoring and reporting devices once they are on the market. The clearer and more robust measures have been introduced to improve patient safety and reduce adverse incidents by requiring manufacturers to identify and address issues earlier.
See: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations
Breakthrough in next-generation polio vaccines
Researchers have taken a major step towards producing a more affordable and lower-risk polio vaccine using Virus-like Particles (VLPs). These particles mimic the outer protein shell of poliovirus but are empty inside. This means there is no risk of infection, but the VLP still causes the immune system to respond.
The international research collaboration, which was funded by the World Health Organization, also included researchers from the University of Oxford, the MHRA, the John Innes Centre, The Pirbright Institute, the University of Florida and the University of Reading. The structural data was collected using a cryo-electron microscope at Diamond Light Source.
See: http://dx.doi.org/10.1038/s41467-025-56118-z
Reference standards
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published its monthly newsletter on European Pharmacopoeia reference standards. It includes information on new and replacement batches, distribution quotas, the removal and future removal of reference standards, changes in sales units, amounts per unit, price and in EDQM storage and/or shipping conditions, as well as information on International Chemical Reference Substances and International Standards for Antibiotics.
For details, see: https://www.edqm.eu/documents/52006/2175121/EDQM%20reference%20standards%20monthly%20newsletter%20%E2%80%93%20February%202025.pdf/6412008a-a0d3-b11a-6dc6-a0db8138059b?t=1741008835771
Unregulated Advanced Therapy Medical Products pose serious risks to health
According to the European Medicines Agency (EMA), several individuals, companies and clinics have been marketing unregulated ATMPs directly to patients, often when there is little or no evidence that the products work or are safe. Some of the unregulated products in the EU are sold as dendritic cell therapies, which use a type of immune cell to attack cancer cells.
Authorities are warning the public that unregulated products could put patients at risk, causing serious side effects while not providing benefits to patients. Additionally, unregulated ATMPs present significant quality-related risks due to the lack of strict oversight and regulatory compliance in the manufacturing process, which can lead to contamination, inconsistent product composition and improper storage. Patients may also face substantial financial costs and emotional distress from ineffective or harmful treatments.
For further details, see: https://www.ema.europa.eu/en/news/unregulated-advanced-therapy-medicinal-products-pose-serious-risks-health
Treatment of patients with Acute Respiratory Distress Syndrome (ARDS)
The EMA has issued a draft guidance document titled ‘Guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome’.
This is to provide guidance for the development of medicinal products for the treatment of ARDS and/or preventing disease progression.
See: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-patients-acute-respiratory-distress-syndrome-revision-2_en.pdf
European Pharmacopoeia publication schedule
The publication schedule for the 12th edition of the European Pharmacopeia is:
- Edition 12.1 - July 2025
- Edition 12.2 – October 2025
- Edition 12.3 – January 2026
In addition, the European Pharmacopeia has updated its Style Guide for the interpretation of pharmacopeia texts. This can be found here: https://pharmeuropa.edqm.eu/media/homepage/documents/2025/02/04/NEW_European_Pharmacopoeia_Style_Guide___Guide_de_r%C3%A9dactio_mjt1kvZ.pdf
Analytical instruments
For analytical laboratories, the USP has issued a draft chapter titled ‘〈1058〉 Analytical Instrument Qualification’.
This informational chapter provides general guidance on taking a risk-based approach to Analytical Instrument and System Qualification (AISQ). It is left to each laboratory to justify and document its specific approaches. The instrument owners and/or users and their management are responsible for assuring their instruments and systems are suitably qualified or validated.
This chapter uses various terms, acronyms and activities common to analytical laboratories and validation disciplines. These terms and activities may not be identical to their usages in all laboratories.
The draft is available via Pharmacopeial Forum (this requires a subscription).
European Commission shares priorities
The European Commission (EC) shared its priorities for 2025. The primary message: ‘Moving forward together: A Bolder, Simpler, Faster Union’.
The communication describes the actions the EC intends to prioritise under the EC President, Ursula von der Leyen, for the 2025 year to fortify and unite the European Union (EU).
See: https://commission.europa.eu/strategy-and-policy/strategy-documents/commission-work-programme/commission-work-programme-2025_en
EU Health Technology Assessment (HTA) for oncology medicinal products and ATMPs
Regulation (EU) 2021/2282 on Health Technology Assessment (HTAR), which entered into force on January 11, 2022, applies from January 12, 2025.
This is set to change the way new treatments are evaluated, introducing joint clinical assessments. These will be carried out in parallel with the European marketing authorisation procedure.
From 2025, oncology medicinal products and ATMPs will be evaluated under the HTAR, followed by orphan drugs from 2028 and finally all centrally authorised medicinal products from 2030.
See: https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment_en
