Read our guidance documents, technical briefs, and job aids for more information about medical products, including emergency use authorization.
Guidance documents and technical briefs
- Substandard and falsified medicines burden model (Sept 2024)
- Selecting software solutions for dossier and quality management (Sept 2024)
- Guide for conducting risk-based inspections using the PQM+ risk-based inspection tool (Sept 2024)
- COVID therapeutics support brief: Results and recommendations (May 2024)
- Emergency use authorizations for therapeutics: Guidance for national medicine regulatory authorities Dec 2023
- Facilitated regulatory pathways model dossier Dec 2023
- Test-to-Treat resource: Scientific and technical information on COVID-19 therapeutics Sept 2023
- Product information report: Gentamicin March 2023
- Technical brief: 4-Chloroaniline (4CA) impurity in Chlorhexidine (PDF) Sept 2022
- A proposed model to build capacity for emergency use authorization for vaccines (PDF) Nov 2021
- A proposed model to build capacity for emergency use authorization for diagnostics (PDF) Nov 2021
- Guidance document for developing and implementing a risk-based PMS for maternal, neonatal, and child health products (PDF) (EN, FR) Feb 2021
- Manual on testing dexamethasone tablets and injections using GPHF-Minilab™ (PDF) Feb 2020
- Guidance on development, manufacture of Chlorhexidine digluconate (7.1%) gel (PDF) June 2019
Job aids
- Competency Framework for Regulators of Biologicals Including Vaccines (PDF) Mar 2024
- Competency Framework Organizational Capability Assessment Tool (Excel) Mar 2024
- Gentamicin injection job aid to assist with laboratory testing (PDF) Apr 2023
- Gentamicin injection job aid to assist with dossier preparation (PDF) Apr 2023
- Chlorhexidine gel 7.1% job aid to assist with laboratory testing (PDF) (EN, FR) Jan 2021
- Chlorhexidine digluconate (7.1%) gel job aid to assist with dossier preparation (PDF) (EN, FR) Jan 2021
- Oxytocin injection job aid to assist with dossier preparation (PDF) (EN, FR) Jan 2021
- Oxytocin injection job aid to assist with laboratory testing (PDF) (EN, FR) Jan 2021
- Amoxicillin job aid to assist with dossier preparation (PDF) (EN, FR) Nov 2020
- Amoxicillin job aid to assist with laboratory testing (PDF) (EN, FR) Nov 2020
