The MHRA and FDA will work closely on options to improve and align regulations for medical devices. This includes exploring future mutual recognition mechanisms (ways to recognise parts of the individual approval processes), reducing duplication for manufacturers and streamlining approval processes to help patients access new medical technologies sooner. 

 

For details, see: https://www.gov.uk/government/news/uk-and-us-deepen-regulatory-cooperation-on-medical-devices-building-on-wider-pharmaceutical-partnership

 

 

Animal testing

 

The MHRA has taken decisive action to phase out animal testing by helping developers to make greater use of New Approach Methodologies (NAMs). 

 

The move supports the Government’s long-term strategy to reduce the use of animals in drug development (where complete elimination is not yet feasible) and ensure medicines continue to meet rigorous standards of safety and efficacy.

 

For details, see: https://www.gov.uk/government/news/mhra-action-boosts-drive-to-phase-out-animal-testing 

 

 

 

Updated and Expanded ICH Q9(R1) Quality Risk Management Briefing Pack

 

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published an updated and expanded Q9(R1) Quality Risk Management Briefing Pack. This is to support the implementation of a systematic approach to Quality Risk Management (QRM) in pharmaceutical development, manufacturing and distribution.

 

The updated ICH Q9(R1) Briefing Pack reflects the new guidance on QRM that appears in the revised ICH Q9(R1) Guideline that was finalised in 2023. 

 

The ICH Q9(R1) Briefing Pack contains a new introductory presentation, nine training presentations on QRM methods and tools (reflecting Annex I of the Guideline) and nine training presentations on the potential applications of QRM (reflecting Annex II of the Guideline).

 

The briefing pack can be accessed here: https://ich.org/page/briefing-pack

 

 

 

GAMP Good Practice Guide: GxP Process Control Systems 3rd Edition

 

The International Society for Pharmaceutical Engineering (ISPE) has published its 3rd edition of ‘GAMP Good Practice Guide: GxP Process Control Systems’.

 

The update addresses technology advances in modular plant design, cloud and SaaS integration, software development tools, artificial intelligence and operational technology cybersecurity. The Guide also embraces methodologies such as Pharma 4.0™, continuous manufacturing, medical device production and personalised medicine.

 

The guide needs to be purchased from ISPE. Further details can be found here: https://ispe.org/publications/guidance-documents/gamp-good-practice-guide-gxp-process-control-systems-3rd-edition 

 

 

 

Maximum residue limits

 

The Maximum Residue Limit (MRL) is the highest concentration allowed for a residue in a food product obtained from an animal that has received a veterinary medicine or that has been exposed to a product used to kill or control germs or pests affecting animals.

 

The European Medicines Agency (EMA) has updated its questions and answers document: https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/maximum-residue-limits-mrl/maximum-residue-limits-mrls-questions-answers 

 

 

 

Medicine safety data

 

The EMA has issued a document designed to provide instructions on the practical implementation of the ICH E2D(R1) Guideline - Post-approval safety data: definitions and standards for management and reporting of individual case safety reports (EMA/CHMP/ICH/59123/2024) in the European Union (EU).

The document is intended to provide guidance for Marketing Authorisation Holders (MAHs), as well as for National Competent Authorities (NCAs) and inspectors.

The document can be accessed here: https://www.ema.europa.eu/en/documents/scientific-guideline/eu-implementation-strategy-ich-e2dr1-guideline-post-approval-safety-data-definitions-standards-management-reporting-individual-case-safety-reports_en.pdf 

EMA has also issued a document titled ‘Data Quality Framework for EU medicines regulation: application to Real-World Data’. This document can be retrieved from: https://www.ema.europa.eu/en/documents/other/data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf

 

 

 

EMA official languages update

 

EMA has updated its list of official languages for each EU member state, as part of the requirements for medicine labelling. The update is primarily for the Czech Republic now officially named Czechia.

 

See: https://www.ema.europa.eu/en/documents/other/list-official-languages-country_en.pdf 

 

 

 

USP updates

 

From the Pharmacopeial Forum edition 52.1, the United States Pharmacopeia (USP) is currently reviewing:

 

Subvisible particles

This is a planned deletion of chapter ‘〈787〉 Subvisible Particulate Matter in Therapeutic Protein Injections’ and the incorporation into the harmonised chapter <788>.

 

The title of <788> will be revised from ‘Particulate Matter in Injections’ to ‘Subvisible Particulate Matter in Injections’. This paves the way for harmonisation with the European Pharmacopeia chapter 2.9.19.

 

Sterilisation

The USP is updating the following chapters:

 

• 1229    Sterilization of compendial articles

 

The suggested change is to consolidate content by integrating relevant text from the following chapters:

 

• Steam Sterilization by Direct Contact 〈1229.1〉 
• Moist Heat Sterilization of Aqueous Liquids 〈1229.2〉 
• Biological Indicators for Sterilization 〈1229.5〉 (scheduled for omission)
• Physicochemical Integrators and Indicators for Sterilization 〈1229.9〉 (scheduled for omission)
• Sterilization Cycle Development 〈1229.14〉 (scheduled for omission)

 

There are also updates planned for:

 

• 1229.1    Moist Heat Sterilization
• 1229.2    Sterilizing Filtration of Liquids

 

With retitling of chapter <1229,2>, chapter 1229.4 will be deleted.

 

Physical environments for medication use

USP is updating its 2015 chapter ‘Physical Environments That Promote Safe Medication Use 〈1066〉’. The main changes are:

 

• Restructuring the chapter so that the information presented is more organised.
• Removing ‘procurement’ from 1. Introduction.
• Renaming ‘Organizational Support’ to ‘2. Organizational Factors’.
• Renaming ‘Principles from Human-Factors Research’ to ‘4. Human Factors Engineering (HFE) Principles of Safety’.
• Adding definitions of medication errors.
• Adding information on High-Reliability Organization (HRO).
• Adding globally inclusive language for non-US stakeholders.
• Updating recommendations for work system and physical environment design.
• Updating ‘9. The Home Environment’ to include more information on medication storage, disposal and transport to the home environment.

 

 

 

European Pharmacopeia updates

 

Edition 13.1 of the European Pharmacopeia (EP) will become effective on 1st January 2027. Some of the changes include:

 

2.1.7. Balances for analytical purposes 

The changes include definitions of multi-interval and multiple range balances introduced. Clarifications of technical terms relating to equipment performance made. Section on minimum weight expanded. 

 

2.4.35. Extractable elements in plastic materials for pharmaceutical use 

The changes relate to determination: a non-exhaustive list of elements determined using this analytical procedure has been included to enhance the clarity of the text. 

 

2.5.43. Size exclusion chromatography for recombinant therapeutic monoclonal antibodies 

This new general chapter describes two Size Exclusion Chromatography (SEC) procedures - HPLC (Procedure A) and UHPLC (Procedure B) - as suitable generic procedures for determination of the monomer and high molecular weight species in monoclonal antibodies in order to monitor their stability, quality and production consistency.

 

2.8.25. High-performance thin-layer chromatography of herbal products 

The text now refers more generally to ‘herbal products’, giving the possibility to apply the HPTLC technique beyond herbal drugs and herbal drug preparations.

 

2.9.1. Disintegration of tablets and capsules

The following changes are included:

 

• Test B (intended for tablets and capsules larger than 18 mm) has been harmonised, including the introduction of an additional requirement for the inner diameter of the beaker
• The dimensional requirements for the basket-rack assembly are now given in a consistent manner across tests A and B; 
• The general chapter now explicitly allows the use of automatic disintegration-detection instruments.

 

2.9.19. Particulate contamination: Sub-visible particles 

This text corresponds to the sign-off text signed by the Pharmacopoeial Discussion Group (PDG). The co-ordinating pharmacopoeia is the USP. 

 

With the chapter:

 

• Method 1. Light obscuration count test: The alternative test procedure (which allows the use of sample volumes of less than 5 mL depending on instrument capability/sample properties) - now harmonised - has become the only test procedure.
• Method 2. Microscopic particle count test: The alternative test procedure - now harmonised - has become the only test procedure. As a result, the obligation to combine at least 10 units for small-volume preparations has been removed.

 

2.6.14. Bacterial endotoxins 

This general chapter has been revised to introduce the fluorimetric end-point method using recombinant factor C (rFC) as the new method G. The proposed technical content concerning method G in the introduction and sections 2 and 9 has been imported from general chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C. Some editorial adjustments have also been made to the ntroduction and sections 5 and 6 to take account of the new method.

 

These changes also impact:

 

• 2.6.39. Microbiological examination of human tissues
• 5.1.10. Guidelines for using the test for bacterial endotoxins
• 5.1.13. Pyrogenicity
• 5.32. Cell-based preparations for human use
• 5.34. Additional information on gene therapy medicinal products for human use
• 5.36. mRNA vaccines for human use
• 5.37. Recombinant viral vectored vaccines for human use
• 5.39. mRNA substances for the production of mRNA vaccines for human use
• 5.40. DNA templates for the preparation of mRNA substances
• Gene therapy medicinal products for human use (3186)
• Substances for pharmaceutical use (2034)
• Parenteral preparations (0520)