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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)

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