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Select Committee
Inquiry into Veterinary Medicines and The Windsor Framework: Roundtable meeting with Northern Ireland based stakeholders, 1 February 2024, Belfast - Note of discussion

Engagement document Apr. 09 2024

Committee: Windsor Framework Sub-Committee

Found: The core objective of this w as to actively demonstrate the sector’s reduction in the use of antibiotics

Non-Departmental Publication (News and Communications)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: Combined antibiotic approved to treat adult patients with severe infections of the urinary tract and hospital-acquired pneumonia
Document: Combined antibiotic approved to treat adult patients with severe infections of the urinary tract and hospital-acquired pneumonia (webpage)

Found: When infections in the urinary tract or lungs (pneumonia) develop resistance to traditional antibiotics

Non-Departmental Publication (News and Communications)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: National Patient Safety Alert: ​​Reducing risks for transfusion-associated circulatory overload​ ​(NatPSA/2024/004/MHRA​)
Document: within TACO chapter (PDF)

Found: received oxygen via continuous positive airway pressure, a diuretic, hydrocortisone, bronchodilator and antibiotics

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: E7 – Studies in Support of Special Populations: Geriatrics (PDF)

Found: effects of known inhibitors, such as quinidine (for cytochrome P-450 2D6) or ketoconazole and macrolide antibiotics

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: E10 – Choice of Control Group and Related Issues in Clinical Trials (PDF)

Found: reasons, and if a defined treatment effect of the active control is regularly seen (e.g., as it is for antibiotics

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: Q5D – Derivation and Characterisation of Cell Substrates Used for Productions of Biotechnological/Biological Products (PDF)

Found: cells cultivated from cell banks with the exception of microbial metabolites such as, for example, antibiotics

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: E17 – General Principles for planning and design of Multi-Regional Clinical Trials (PDF)

Found: prevalent in a single region (e.g., anti-malarial drugs, vaccines specific to local epidemics, or antibiotics

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: Q5C – Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products (PDF)

Found: The document does not cover antibiotics, allergenic extracts, heparins, vitamins, whole blood, or cellular

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: S2(R1) – Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use (PDF)

Found: Compounds that are Toxic to Bacteria In cases where compounds are highly toxic to bacteria (e.g., some antibiotics

Non-Departmental Publication (Guidance and Regulation)
Medicines and Healthcare products Regulatory Agency

Apr. 04 2024

Source Page: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Document: Q1A(R2) – Stability Testing of New Drug Substances and Products (PDF)

Found: The same may be true for certain antibiotics.