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
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