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Reports and references

Opportunities for improving access to vaccines in emerging countries through efficient and aligned registration procedures: An industry perspective. Delepiane N, et al.
https://www.ncbi.nlm.nih.gov/pubmed/31027928

Challenges for the registration of vaccines in emerging countries: Differences in dossier requirements, application and evaluation processes. Delepiane N, et al.
https://www.ncbi.nlm.nih.gov/pubmed/29724510

Handling of Post-Approval Changes to Marketing Authorizations: IFPMA report, 2019
https://www.ifpma.org/wp-content/uploads/2018/11/IFPMA-PACs-Brochure.pdf

EMA procedural advice for medicinal products intended exclusively for markets outside the European Union under Article 58 of Regulation (EC) No 726/2004 in the context of co-operation with the World Health Organisation (WHO)
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-procedural-advice-medicinal-products-intended-exclusively-markets-outside/2004-context-cooperation-world-health_en.pdf

Emergency Use listing procedure
https://www.who.int/immunization_standards/vaccine_quality/EUL/en/

POLICY- Evaluating and publicly designating regulatory authorities as WHO listed authorities: 2019 Draft for comments https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS19_828_Policy_on_WHO_Listed_Authorities.pdf?ua=1

Collaborative procedure between the World Health Organization (WHO) Prequalification Team and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines. WHO TRS 996, Annex 8 : 2016 (here attached as file named WHO TRS 996 Annex 08)
WHO TRS 996 Annex 08 (PDF)

WHO Listed Authorities (WLA) consultative meeting
WLA consultative meeting SH (PDF)
Comments WLA WHO 2nd july SD (PDF)

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