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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.

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: S5(R3) – Revision of S5 Guidelines on Detection of Toxicity to Reproduction for Human Pharmaceuticals (PDF)

Found: fertility and pre -/postnatal studies • Sensitive to gastr ointestinal disturbances; (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: S6(R1) – Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (PDF)

Found: This document does not cover antibiotics, allergenic extracts, heparin, vitamins, cellular blood components

Select Committee
2024-03-26 10:00:00+00:00

Oral Evidence Mar. 26 2024

Inquiry: Pharmacy
Inquiry Status: Closed
Committee: Health and Social Care Committee (Department: Department of Health and Social Care)

Found: an evaluation commissioned around antimicrobial resistance and looking at the total quantity of antibiotics

Select Committee
Fifth Report - The prevalence of sexually transmitted infections in young people and other high risk groups

Report Mar. 26 2024

Committee: Women and Equalities Committee

Found: gonorrhoea as “one of the most highly drug-resistant organisms we have”, with very few effective antibiotics

Non-Departmental Publication (News and Communications)
Veterinary Medicines Directorate

Mar. 25 2024

Source Page: Recruitment for two Non-Executive Directors
Document: Candidate Information Pack (PDF)

Found: VMD), but have you ever: •eaten meat, eggs, fish or honey •drunk milk •owned a pet or animal •taken antibiotics