On 2 February 2026, the U.S. Food and Drug Administration’s (FDA’s) Quality Management System Regulation (QMSR) comes into force, bringing important changes to how US medical device quality systems are assessed. QMSR replaces the existing QSR and formally aligns FDA requirements with ISO 13485.
This change came about following the amendment of the Current Good Manufacturing Practice (CGMP) requirement of the Quality System Regulation (QSR) (21 CFR Part 820) to incorporate by reference, and thereby align more closely with, the international consensus standard ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes.
The European Pharmacopeia (Ph. Eur.) has published its programme of works for 2026. To see which chapters and monographs are set to be updated, visit: https://www.edqm.eu/documents/52006/278487/PhEurWorkProgrammeNov2025_E.pdf/0c5e20f7-1369-fb87-7995-f2b8214b7103?t=1768905286060
Edition 12.3 will be published on 28 February 2026, with an implementation date of 1 July 2026.
There will be a new general chapter - 5.38. Quality of data
In addition, there will be revisions to:
2.2.44. Total organic carbon in water for pharmaceutical use
2.7.23. Numeration of CD34/CD45+ cells in haematopoietic products
2.9.42. Dissolution test for lipophilic solid dosage forms
2.9.43. Apparent dissolution
4. Reagents
5.2.5. Management of extraneous agents in immunological veterinary medicinal products
5.22. Names of herbal drugs used in traditional Chinese medicine
The European Pharmacopeia is set to update ‘3.2.9. Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powder’, with a draft text available for comment.
There is one planned change: ‘Volatile sulfides: following issues regarding the availability of sodium sulfide R, the reagent used in the test has been changed to thioacetamide R, which also improves the visibility of the test results.’
The text is available to view online, however a registration is required.
The FDA is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT). The agency’s more flexible approach has been, and is expected to continue to be, helpful in expediting product development and will help guide the FDA’s evaluation of development strategies in preparation for a Biologics License Application (BLA) submission.
The FDA has produced a list of guidance topics that the Center for Biologics Evaluation and Research (CBER) is considering for development during 2026.
The list includes topics that currently have no guidance associated with them and those where updated guidance may be helpful. Additional topics are those which CBER has already issued Level 1 draft guidances that may be finalised following review of public comments.
While the FDA currently intend to develop guidance documents on these topics, the Center is neither bound by this list of topics, nor required to issue every guidance document on the list.
To access see: https://www.fda.gov/media/120341/download
Artificial Intelligence (AI) has the potential to transform the way medicines are developed and evaluated, ultimately improving healthcare. In this context, AI refers to system-level technologies used to generate or analyse evidence across the drug product life cycle, including nonclinical, clinical, post-marketing and manufacturing phases.
The European Medicines Agency (EMA) and the FDA have put together ten guiding principles that are intended to lay the foundation for developing good practice that addresses the unique nature of AI technologies. They will also help cultivate future growth in this rapidly progressing field.
The principles are relevant for those developing medicines, as well as for marketing authorisation applicants and holders. They will underpin future AI guidance in the different jurisdictions and support enhanced international collaboration among regulators, organisations setting technical standards and other stakeholders.
The document can be accessed here: https://www.ema.europa.eu/en/documents/other/guiding-principles-good-ai-practice-drug-development_en.pdf
The FDA has released a new tool for the toxicity screening of chemicals in food. This is the Expanded Decision Tree (EDT), a chemical toxicity and risk screening tool.
The tool provides a consistent, systematic and science-based approach to support evaluation of the safety of chemicals in food based on their structure and estimated toxicity. The EDT was evaluated through external peer review, marking a significant milestone in its development.
For details see: https://www.fda.gov/food/food-chemical-safety/expanded-decision-tree-fdas-food-chemical-toxicity-screening-tool
The Association of Official Analytical Collaboration (AOAC) International has released a document titled ‘Guidelines for Validation of Qualitative Gluten Methods with Specific Examples – Lateral Flow Devices’, examining the testing of gluten in food.
The integrity of gluten testing relies on methods that are reproducible, comparable and fit for purpose across diverse settings. The new guideline addresses ongoing challenges in method validation with a harmonised, consensus-based framework. The standard provides clear technical requirements for single-laboratory, independent and collaborative validation studies. It includes practical examples (such as lateral flow devices) and is intentionally designed to serve laboratories, regulators and industry worldwide.
Further details can be found here: https://www.aoac.org/news/new-qualitative-gluten-guideline-release/
The EMA has issued a factsheet titled ‘Revolutionising Clinical Trials’, which looks at key changes under the European New Biotech Act.
The Act sets out to achieve:
To access, see: https://health.ec.europa.eu/publications/factsheet-revolutionising-clinical-trials_en
Other factsheets of interest include:
On 1 January 2026, the Jordan Food & Drug Administration (JFDA) became the 57th PIC/S Participating Authority. See: https://picscheme.org/en/news/jordan-jfda-joins-pics
The joint EMA - PIC/S drafting group has developed a concept paper on the revision of the Annex 3 (Good Manufacturing Practice for Radiopharmaceuticals) of the Good Manufacturing Practice (GMP) Guide.
This concept paper aims to outline the rationale, objectives and proposed changes for updating the Annex 3, Manufacture of Radiopharmaceuticals, of the Good Manufacturing Practice (GMP) Guide, that is common to the Member States of the European Union (EU) / European Economic Area (EEA), as well as to the Participating Authorities (PAs) of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
The aim of the revision is to provide guidance within some areas that were not covered in the current version issued in 2008, clarify some sections and support innovative pharmaceutical manufacturing and control approaches.
This concept paper is submitted to a joint EMA - PIC/S public consultation until 15 February 2026.
The concept paper can be found here: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/good-manufacturing-practice-gmp-good-distribution-practice-gdp-inspectors-working-group#concept-papers-reflection-papers-and-draft-guidelines-8390
EMA has updated the document ‘Abbreviations used in EMA scientific committees & CMD documents and in relation to EMA’s regulatory activities’. This is an ongoing collection of official abbreviations.
The document can be found here: https://www.ema.europa.eu/en/documents/other/abbreviations-used-ema-scientific-committees-coordination-group-mutual-recognition-decentralised-procedures-cmd-documents-relation-emas-regulatory-activities_en.pdf
FDA has issued a draft guidance document based on the ICH M4Q(R2) document.
The M4Q(R2) guideline establishes the location and structure of quality information for registration applications of all medicinal products for human use. It supports various submission types, including those referring to or consisting of master files and applies to both initial marketing authorisation and post-approval submissions. This guideline is structured to be flexible to accommodate all types of medicinal products and their components.
To access, see: https://www.fda.gov/media/190641/download
The FDA is announcing the availability of a final guidance entitled ‘Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices’. The FDA is issuing this guidance to clarify how they FDA evaluate Real-World Data (RWD) to determine whether they are of sufficient quality for generating Real-World Evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This final guidance supersedes the final guidance - ‘Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices’ - issued August 31 2017 and provides expanded and updated recommendations.
For further details, see the Federal Register: https://www.federalregister.gov/documents/2025/12/18/2025-23252/use-of-real-world-evidence-to-support-regulatory-decision-making-for-medical-devices-guidance-for
The E2B(R3) Expert Working Group has published an Information Paper to explain the alignment of ICH E2B(R3) specifications with the revised ICH E2D Guideline.
The E2B(R3) Expert Working Group has also published an Implementation Guide Package with Code List. The ICH E2D Guideline: ‘Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports’ provides guidance on definitions and standards for individual case safety reporting after a product is approved by regulatory authorities, as well as good case management practices. It was updated in September 2025 and the changes have implications for E2B(R3).
Both Guidelines are related to ICH’s harmonised electronic standards work, which is advanced by ICH Expert Working Groups, as well as joint initiatives with other standards development organisations to ensure global interoperability. Harmonising these standards facilitates the electronic exchange of data by regulatory authorities and pharmaceutical companies.
For details see: https://admin.ich.org/sites/default/files/inline-files/E2B%28R3%29_InfoPaper_MCApproved_20251216.pdf
The ICH M4Q(R2) Expert Working Group has issued a Mapping Document to support understanding of revisions to the Quality section of the Common Technical Document. The Mapping Document provides a high level, conceptual mapping between the earlier version, M4Q(R1) (finalised in 2002). The revised version that is now in development is based on the M4Q(R2) Step 2 version of the draft Guideline that was endorsed in May 2025.
The Common Technical Document is a standardised, easy-to-follow format used by pharmaceutical companies when they submit new drug applications to regulatory authorities. Before the development of the Common Technical Document, regions had different documentation requirements, which slowed down the submission of documentation in different regions and increased the likelihood of errors. The Quality section of the Common Technical Document provides a harmonised structure and format for presenting chemistry, manufacturing and controls information in a registration dossier.
For details see: https://database.ich.org/sites/default/files/ICH_M4Q%28R2%29_MappingDocument_2026_0112.pdf
In a new addition to the training library, Module 4: Informed Consent, a two-part training module has just been published for ICH E6(R3) Good Clinical Practice Guideline.
E6(R3) Good Clinical Practice is an international, ethical, scientific and quality standard for the conduct of clinical trials that involve human participants. Clinical trials conducted in accordance with this standard help to ensure that the rights, safety and well-being of trial participants are protected. Module 4 of the training materials concerns informed consent, an integral feature of the ethical conduct of a trial.
For details, see: https://www.ich.org/page/training-library#36-2
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