The European Pharmacopoeia (Ph. Eur.) is revising chapter ‘2.4.24. Identification and Control of Residual Solvents’ to improve clarity.
The distinction between non-targeted and targeted analysis has been made explicit and a separate system suitability solution (prepared from a subset of Class 2 residual solvents) has been included. In addition, the chromatograms of Class 2 residual solvents have been updated to include cyclopentyl methyl ether and tertiary-butyl alcohol.
The draft is accessible via the European Pharmacopeia (requires registration).
The National Institute for Health and Care Excellence (NICE) has launched a consultation to seek the views of external stakeholders on proposed updates to the PMG36 manual (NICE Health Technology Evaluations: The Manual).
The proposed changes to PMG36 are to support the production of technology appraisals on HealthTech (that is, medical devices, diagnostics and digital technologies), as set out in the NHS 10-year plan - not to change the assessment of medicines.
The existing manual can be used to develop technology appraisal guidance on HealthTech; however, technology appraisal guidance has predominantly focused on medicines. The update will provide details on the processes and methods to develop technology appraisal guidance more suited to the HealthTech landscape.
The consultation will be made available via the following link: https://www.nice.org.uk/guidance/indevelopment/GID-PMG10017
The global quality standard, ISO 9001, is set to have a new edition in 2026. This is divided into:
Both have the status of ‘Draft International Standard’ (DIS). Copies are available via ISO.
The European Medicines Agency (EMA) has issued a draft guideline to clarify the regulatory expectations for quality documentation of bacteriophage active substances and finished products for human use within marketing authorisation applications.
The guideline addresses specific aspects regarding the manufacture, control of materials, characterisation, specifications, analytical control, reference standards and stability of bacteriophage active substances. In addition, guidance is given on the pharmaceutical development, manufacture, control and stability of the finished product.
Comments are open until 30th April 2026, see: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-aspects-phage-therapy-medicinal-products_en.pdf
The EMA has issued a draft guide on monoclonal antibodies, titled ‘Draft Qualification Opinion for Molecule-Independent Device Bridging Approach (MIDBA)’.
The MIDBA is qualified as an alternative methodology for clinical bridging from manual subcutaneous injection via a handheld syringe or prefilled syringe, to an autoinjector platform (specifically the YpsoMate 2.25 and 1.0 AIs) for monoclonal antibodies (mAbs).
With the MIDBA, it is proposed that individual clinical device qualification for mAbs using the YpsoMate AI platform is replaced by referring to available pharmacokinetic (PK) comparability data generated with other mAbs for the same AI platform. This approach would omit the need to generate molecule-specific PK comparability assessments for new mAbs using the YpsoMate AI.
To review, see: https://www.ema.europa.eu/en/documents/other/draft-qualification-opinion-molecule-independent-device-bridging-approach-midba_en.pdf
The Ph. Eur. chapter ‘2.8.23. Microscopic examination of herbal drugs’, is to be updated to allow for more flexibility in particle size. The draft is accessible via the European Pharmacopeia (requires registration).
The text in the Ph. Eur. for ‘Parenteral Preparations’ (520) is undergoing revision. The key changes are:
Definition:
Injections:
Powders for injection or infusion:
The draft is accessible via the European Pharmacopeia (requires registration).
In accordance with the obligations laid down by the Commission Implementing Regulation (EU) No 520/2012 (articles 25 and 26), the EMA is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the Identification of Medicinal Products (IDMP).
The European Union (EU) Member States, Marketing Authorisation Holders (MAHs) and EMA are required to make use of the ISO IDMP standards to support the exchange of medicinal product information in standardised manner.
EMA is implementing the standards in a phased programme based on the four domains of master data in pharmaceutical regulatory processes: Substance, Product, Organisation and Referential (SPOR) master data.
The five ISO standards provide data elements and structures to uniquely identify and exchange information on:
The document can be accessed here: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/products-management-services-pms-implementation-international-organization-standardization-iso-standards-identification-medicinal-products-idmp-europe-chapter-1-registration-requirements_en.pdf
The Ph. Eur. chapter ‘3.2.9. Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders’ is under revision.
The primary changes are:
The draft is accessible via the European Pharmacopeia (requires registration).
Parallel distribution is the distribution of a centrally authorised medicinal product from one country to another by a pharmaceutical company independent of the marketing-authorisation holder.
The EMA has updated its question-and-answer document for parallel distribution. The updated document can be found here: https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-about-parallel-distribution_en.pdf
According to the MHRA, the most significant update to UK clinical trials regulations in two decades will come into force on 28 April 2026:
‘The implementation of the latest international Good Clinical Practice (GCP) guidelines (ICH-GCP E6(R3)) will come into force in the UK, along with the updated regulations. All trials will need to adhere to the principles of GCP and trials for marketing authorisation will need to comply with the full guidelines.’
For further details, see: https://mhrainspectorate.blog.gov.uk/2025/10/28/clinical-trials-regulations-six-month-countdown-begins/
The International Conference on Harmonisation (ICH) has issued a guideline which recommends international standards for, and promotes harmonisation of, the general principles on planning, designing, analysing and reporting of noninterventional studies that utilise fit-for-use data for safety assessment of medicines.
The guideline outlines recommendations and high-level best practices for the conduct of non-interventional pharmacoepidemiologic safety studies to streamline the development and regulatory assessment of study protocols and reports. The guideline recommends an iterative approach to study development, focusing on assessment of data fitness-for-use, feasibility assessments to guide study design and further refinement of design based on feasibility results.
The recommendations are intended to minimise the conduct of multiple studies on the same safety concern for regulatory submissions, improve the regulatory acceptance of the protocol across regions, and ultimately to support regulatory decision making.
The document is titled ‘ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines - Scientific guideline’.
The guideline can be found here: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m14-guideline-general-principles-planning-designing-analysing-reporting-non-interventional-studies-utilise-real-world-data-safety-assessment-medicines-step-5_en.pdf
The EMA has made an update to its ‘Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products’.
The update relates to the question: ‘What is the approach to control presence of N-nitrosamine exceeding the AI during CAPA implementation?’
The updated document can be found here: https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/nitrosamines-emea-h-a53-1490-questions-answers-marketing-authorisation-holders-applicants-chmp-opinion-article-53-regulation-ec-no-726-2004-referral-nitrosamine-impurities-human-medicinal-products_en.pdf
The EMA has updated its question-and-answer document regarding mutual recognition with the U.S. Food and Drug Administration (FDA). This is the document ‘Q&A on impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations.’
The document can be found here: https://www.ema.europa.eu/en/documents/other/qa-impact-eu-usa-mutual-recognition-agreement-marketing-authorisation-applications-relevant-variations-revised-1st-october-2025_en.pdf
The FDA has issued a draft guidance document titled ‘Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies’.
The document describes considerations regarding a comparative clinical study or studies with efficacy endpoints (a ‘comparative efficacy study’ or ‘CES’) to support a demonstration of biosimilarity in a Biologics License Application (BLA).
The document can be accessed here: https://www.fda.gov/media/189366/download
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