WHO Technical Report Series TRS 1044, 2022 56th Report

WHO Expert Committee on Specifications for Pharmaceutical Preparations has published the Technical Report Series TRS 1044 on 22 Dec 2022 (Fifty-sixth report) Contents Abbreviations WHO Expert Committee on Specifications for Pharmaceutical Preparations Declarations of interest OPEN SESSION Introduction and welcome I. ECSPP procedures and processes II. Update on new guidelines, norms and standards III. Technical agenda topics of the fifty-sixth ECSPP IV. Points of discussion PRIVATE AND CLOSED SESSIONS Opening Election of chairpersons and rapporteurs Participation in ECSPP meetings 1. General policy 1.1 Process for development of WHO norms and standards 2. General updates and matters for information 2.1 Expert Committee on Biological Standardization 2.2 Expert Committee on the Selection and Use of Essential Medicines 2.3 Prequalification of medicines 2.4 Member State Mechanism and post-market surveillance 2.5 International Conference of Drug Regulatory Authorities 3. Quality assurance: collaboration initiatives 3.1 International Meeting of World Pharmacopoeias 4. Nomenclature, terminology and databases 4.1 International nonproprietary names for pharmaceutical substances 4.2 Quality assurance terminology 4.3 Guidelines and guidance texts adopted by the ECSPP 5. Quality control: national laboratories 5.1 External Quality Assurance Assessment Scheme 5.1.1 Final report on EQAAS phase 10 5.1.2 Update on EQAAS phase 11 6. Quality control: specifications and tests 6.1 The International Pharmacopoeia 6.1.1 Workplan 2022–2023 6.2 General chapters 6.2.1 Chromatography 6.3 Specifications and draft monographs for medicines, including paediatrics and candidate medicines for COVID-19 6.3.1 COVID-19 therapeutics 6.3.2 Medicines for maternal, newborn, child and adolescent health 6.3.3 Antimalarial medicines 6.3.4 Antituberculosis medicines 6.3.5 Antiviral medicines, including antiretrovirals 6.3.6 Other medicines 6.4 Update on the virtual consultations on screening technologies, laboratory tools and pharmacopoeial specifications 7. Quality control: international reference materials 7.1 Update on International Chemical Reference Substances 8. Quality assurance: good manufacturing practices and inspection 8.1 Good manufacturing practices for sterile pharmaceutical products 8.2 Good manufacturing practices for investigational radiopharmaceutical products 8.3 Guidelines on technology transfer in pharmaceutical manufacturing 8.4 Good manufacturing practices for medicinal gases 8.5 Good practices for research and development facilities 8.6 Good manufacturing practices for investigational products 8.7 Recommendations from the virtual consultation on good practices for health products manufacture and inspection 9. Quality assurance: distribution and supply chain 9.1 Setting remaining shelf-life for supply and procurement of emergency health kits 9.2 WHO/UNFPA guidance on natural rubber latex condom stability studies 9.3 WHO/UNFPA technical specification for TCu380A intrauterine device 10. Regulatory guidance and model schemes 10.1 WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for medicines included in the EML 10.2 WHO guidance on registration requirements to establish interchangeability for multisource (generic) products 10.3 Update on WHO-listed authorities 10.4 WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce 10.5 Recommendations from the virtual consultation on regulatory guidance for multisource products 10.6 Ongoing activities and proposed new topics for regulatory guidance and model schemes 11. Miscellaneous: update on COVID-19 activities 11.1 Therapeutic specifications 11.2 Existing guidance 11.3 New activities 12. Closing remarks 13. Summary and recommendations 13.1 Guidelines and decisions adopted and recommended for use 13.2 Texts adopted for inclusion in The International Pharmacopoeia 13.2.1 General chapters 13.2.2 Monographs 13.2.3 International Chemical Reference Substances (ICRS) 13.3 Recommendations 13.3.1 The International Pharmacopoeia 13.3.2 Quality control: national laboratories 13.3.3 Good manufacturing practices and related areas 13.3.4 Distribution and supply chain 13.3.5 Regulatory mechanisms 13.3.6 Other 55 Acknowledgments References Annex 1 Guidelines and guidance texts adopted by the Expert Committee on Specifications for Pharmaceutical Preparations Annex 2 WHO good manufacturing practices for sterile pharmaceutical products Annex 3 IAEA/WHO guideline on good manufacturing practices for investigational radiopharmaceutical products Annex 4 WHO guidelines on technology transfer in pharmaceutical manufacturing Annex 5 WHO good manufacturing practices for medicinal gases Annex 6 WHO good practices for research and development facilities of pharmaceutical products Annex 7 WHO good manufacturing practices for investigational products Annex 8 Points to consider for setting the remaining shelf-life of medical products upon delivery Annex 9 WHO/UNFPA guidance on natural rubber latex male condom stability studies Annex 10 WHO/UNFPA technical specification for TCu380A intrauterine device Annex 11 WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms