Pan American Health Organization · 2021
Regulatory preparedness guidance for national authorities to streamline vaccine authorization, importation, and surveillance during emergencies.
- Issuer
- Pan American Health Organization
- Edition
- 2021
- Audience
- National regulatory authorities, ministries of health, public health professionals
- Evidence
- Expert consensus based on regional regulatory analysis
- Reviewed
- 19 Oct 2026 · GMJ
What this guideline says
GMJ summary
This PAHO document provides recommendations for national regulatory authorities (NRAs) in the Americas on establishing effective emergency regulatory frameworks for vaccine introduction during the COVID-19 pandemic and future emergencies. Based on a November 2020 analysis of 21 NRAs, it identifies significant gaps in regulatory preparedness, including inconsistent authorization mechanisms, unclear import procedures, and variable lot release protocols.
The guidance outlines four main vaccine authorization mechanisms used across the Region: exceptional approval based on reliance on reference entities (76% of NRAs), Emergency Use Authorization (62%), normal registration (43%), and streamlined procedures (24%). Many countries lack clear legal frameworks for these mechanisms, with processes varying significantly depending on procurement pathways.
Core recommendations include: establishing differentiated criteria based on vaccine procurement channels (direct purchase, COVAX, donations); avoiding duplication by relying on decisions from WHO prequalification or stringent regulatory authorities; implementing risk-based lot release that recognizes certificates from reference NRAs; and strengthening post-introduction pharmacovigilance regardless of authorization pathway. The document emphasizes that surveillance activities cannot be delegated and must remain a national responsibility.
Key points
For clinicians — doses and thresholds as stated in the guideline
- NRAs should establish emergency authorization mechanisms distinct from reliance procedures, with clear legal basis, transparency requirements, and validity limited to the emergency duration
- Import permits and customs clearance should take less than five days in emergency situations, with documented mechanisms to waive traditional requirements such as apostilled certificates
- Lot release for imported vaccines from reliable sources (UN agencies, COVAX) should be expedited to less than two days by recognizing certificates from reference NRAs without duplicating quality control
- 71% of NRAs participate in cold chain verification at entry points; all should maintain integrated records enabling tracking of vaccine lots through different procurement routes
- 90% of NRAs participate in ESAVI (adverse events supposedly attributable to vaccination) evaluation; pharmacovigilance plans must incorporate risk management plans from each vaccine manufacturer
- Emergency Use Authorizations require rolling review of manufacturer data, specific conditions (population restrictions, periodic risk management updates, mandatory safety notifications), and legal mechanisms for revocation
- Differentiated authorization criteria should be based on procurement pathway: vaccines through PAHO Revolving Fund or COVAX (which require WHO emergency use listing or prequalification) need minimal national requirements
- Post-introduction surveillance and monitoring cannot be delegated to other authorities and must include information exchange mechanisms with regional NRAs to detect substandard or falsified products
Characteristics of authorization procedures granted in emergency situations
Table extracted from the guideline
| Emergency Use Authorization | Exemptions and reliance on decisions of other authorities |
|---|---|
| Granted on exceptional basis by NRA or ministerial decree; sometimes no formal NRA evaluation required | Requested or authorized through ministries of health; often used for market shortage situations, not only emergencies |
| Based on risk-benefit analysis of limited quality, safety, efficacy data available at authorization | NRA or ministry adopts conditions under which reference NRA granted initial authorization |
| Rolling review process as manufacturer submits information; information submitted by interested party (usually manufacturer) | Authorities must ensure product made using same process, manufacturing sites, and supply chain authorized by reference body |
| Valid only for duration of emergency; administered by national institutions; indications often restricted to high-risk groups | Recommended to keep national-level record of lots used and strengthen quality, safety, efficacy monitoring |
| Periodic updating of risk management plans; mandatory safety notifications following introduction | Although not always envisaged, strengthening surveillance processes recommended for vaccines authorized via this mechanism |
| Conditions subject to review as updated information becomes available; manufacturers legally bound to submit established information | NRA should document decisions based on information used and establish vaccine surveillance mechanisms |
| NRA must have legal mechanisms to revoke EUA for non-compliance with conditions and agreements |
Source: Pan American Health Organization, Recommendations on Regulatory Processes and Aspects related to the Introduction of Vaccines during the COVID-19 Pandemic and Other Emergencies. Reproduced in summary form.
From the guideline
Verbatim
“Post-introduction surveillance and monitoring of vaccines, continuous risk-benefit assessments on the use of vaccines introduced in emergency situations, and timely detection of possible substandard or falsified vaccines cannot be delegated to other regulatory authorities or reference entities.”
Editor’s perspective
Why this matters for Georgia and the region
Prof. Giorgi Pkhakadze, MD, MPH, PhD
Editor-in-Chief, Georgian Medical Journal · Chair, Public Health Institute of Georgia · WHO consultant, health and migration
As Chair of the Public Health Institute of Georgia and having worked closely with WHO on regulatory harmonization, I recognize the critical gaps this document addresses for our region. The 2020 analysis showing 43% of NRAs unfamiliar with readiness assessment tools and inconsistent emergency authorization frameworks reflects challenges we observe across Eastern Europe and the South Caucasus, where regulatory capacity varies significantly between countries. For Georgian colleagues, the most actionable recommendation is establishing clear legal distinction between emergency use authorization requiring risk-benefit analysis and reliance mechanisms that adopt WHO prequalification decisions—this would prevent the regulatory delays we witnessed with COVID-19 vaccine introduction when unclear frameworks caused confusion about required documentation. The realistic implementation challenge for Georgia and neighbouring countries is that while the document recommends surveillance systems that cannot be delegated, many smaller NRAs lack the human resources and laboratory capacity for independent pharmacovigilance at the scale required during mass vaccination campaigns, necessitating regional cooperation networks and technical assistance to operationalize these principles effectively.
ORCID 0000-0001-7609-4515 · Perspective written for the GMJ Guidelines Library, 19 Oct 2026
Applicability
Georgia and the South Caucasus
For Georgia and South Caucasus countries with national immunization programmes and regulatory frameworks, this guidance is directly applicable as these countries procure vaccines through multiple channels including WHO prequalification, bilateral agreements, and international mechanisms like COVAX. Georgia’s national regulatory authority would need to review current legislation to ensure clear legal basis for emergency authorization mechanisms distinct from routine registration, establish documented procedures for expedited import licensing (under five days), and implement lot release protocols that recognize certificates from WHO-prequalified manufacturers or stringent regulatory authorities. The emphasis on mandatory pharmacovigilance regardless of authorization pathway aligns with Georgia’s existing adverse event reporting systems but would require strengthened capacity for risk-benefit assessment and information exchange with regional regulatory networks during health emergencies.
Questions this guideline answers
Quick answers
What is the difference between Emergency Use Authorization and reliance on other authorities' decisions?
Emergency Use Authorization involves the NRA conducting a risk-benefit analysis of limited available data through rolling review, with specific conditions and manufacturer obligations. Reliance mechanisms involve adopting decisions already made by WHO prequalification, stringent regulatory authorities, or regional reference entities, often without formal NRA evaluation, based on trust in the reference body's assessment.
How quickly should vaccine import authorization occur during emergencies?
Import permits and customs clearance should take less than five days. NRAs should consider issuing import permits prior to vaccine arrival and establishing documented mechanisms to waive requirements such as apostilled or translated certificates of pharmaceutical products that may not be available during emergencies.
Should countries conduct their own lot release testing for vaccines obtained through COVAX?
No. WHO recommends that imported vaccines purchased from reliable sources (UN procurement agencies, COVAX Facility) should be exempted from additional quality control in recipient countries. Countries should recognize lot release certificates issued by reference NRAs and aim for release in less than two days to avoid delaying vaccine availability.
Can post-introduction vaccine surveillance be delegated to international authorities?
No. Post-introduction surveillance and monitoring activities, including pharmacovigilance, continuous risk-benefit assessments, and detection of substandard or falsified vaccines, cannot be delegated to other regulatory authorities or reference entities and remain the responsibility of national authorities regardless of authorization pathway or procurement channel.
Related on GMJ
Interconnected resources
Dictionary of Public Health
GMJ News coverage
Quality & accreditation
Other guidelines on this topic
- Guide for the preparation of a risk communication strategy for COVID-19 vaccines
- Crisis Communication related to vaccine safety: Technical guidance
- Considerations on Thrombotic Events Following Administration of the Oxford-AstraZeneca COVID-19 Vaccine in Europe
- Developing national meningitis plans: an operational manual
- Regional Framework for the Monitoring and Re-Verification of Measles, Rubella and Congenital Rubella Syndrome Elimination in the Americas
- Issuer
- Pan American Health Organization
- Type
- Procedures, manuals, guidelines
- Status
- Current
- Published
- 2021-01-01
- Scope
- Americas region national regulatory authorities
- Audience
- National regulatory authorities, ministries of health, public health professionals
- Licence
- CC BY-NC-SA 3.0 IGO
- Evidence
- Expert consensus based on regional regulatory analysis
- Record history
- Created 19 Oct 2026 · updated 19 Oct 2026 · next check Apr 2027
Pan American Health Organization. Recommendations on Regulatory Processes and Aspects related to the Introduction of Vaccines during the COVID-19 Pandemic and Other Emergencies. Washington, DC: PAHO; 2021.GMJ Guidelines Library records are original summaries written by the GMJ editorial team from the issuer’s published document and reviewed by a physician. They do not replace the full guideline. The document is the copyright of its issuer and is linked, not hosted. Spotted an error or a newer edition? Tell the Guidelines Desk.
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