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

Apr. 09 2024

Source Page: MHRA FOI performance data
Document: (Excel)

Found: This was approved by FDA in November last year: https://www.fda.gov/drugs/resources-information-approved-drugs

Non-Departmental Publication (Guidance and Regulation)
UK Export Finance (UKEF)

Apr. 04 2024

Source Page: Category A project under consideration: Electrification Project, Uíge Province, Angola
Document: Environmental and Social Impact Assessment for Uige Electrification Project – Lot 1, Phase 2 (PDF)

Found: traffic management plan with the following dimensions: safety, rules of behaviour, consumption of drugs

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: M4E(R2) – CTD on Efficacy (PDF)

Found: ......................... ................................ ................ 29 2.7.4.5.4 Use in Pregnancy

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: S1B(R1) – Testing for Carcinogenicity of Pharmaceuticals (PDF)

Found: of a pharmaceutical present a dilemma to all parties: regulatory reviewers, companies 2 developing drugs

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: E2C(R2) – Periodic Benefit-Risk Evaluation Report (PDF)

Found: 2005 Parent Guideline: Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs

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: E2B(R3) – Questions and Answers (PDF)

Found: 027) November 2014 Clarification was requested for usage on coding reports of possible counterfeit drugs

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: E2D – Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting (PDF)

Found: ......................................................................................... 7 5.4.1 Pregnancy

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: M3(R2) – Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (PDF)

Found: nonclinical pharmacokinetic studies, reproduction toxicity stud ies, genotoxicity studies and, for drugs

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: M3(R2) – Questions and Answers (R2) (PDF)

Found: For inhaled drugs with intended systemic action, the high dose in an inhalation toxicity study could

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: E11(R1) – Clinical Investigation of Medicinal Products in the Pediatric Populations: Guideline and Addendum (PDF)

Found: •Use of sensitive assays for parent drugs and metabolites to decrease the volume of blood required per