Recommendations on Regulatory Processes and Aspects related to the Introduction of Vaccines during the COVID-19 Pandemic and Other Emergencies

The document “Recommendations on Regulatory Processes and Aspects related to the Introduction of Vaccines during the COVID-19 Pandemic and Other Emergencies” is now published in IRIS at .

The objective of this document is to identify the main gaps in readiness for the introduction of COVID-19 vaccines and to propose the regulatory procedures needed to manage and reduce these gaps, which were detected through a situation analysis of the emergency regulatory procedures implemented by national regulatory authorities (NRAs) in the Americas and based on the available information regarding existing regulatory frameworks in the Region. During emergency situations, the World Health Organization (WHO) recommends that NRAs adopt agile and efficient regulatory pathways to evaluate the quality, safety, and efficacy of new vaccines, which should be based on risk-benefit assessments. It also recommends that, for each authorized vaccine, pharmacovigilance activities should be implemented, based on risk management plans. Countries should have national emergency preparedness and response plans that include streamlined regulatory pathways that allow new vaccines to be introduced following legal and orderly processes. This regulatory preparedness is key to achieving a rapid response that does not obstruct or delay the availability of vaccines.


Public consultation on Evaluation of the quality, safety and efficacy of messenger RNA vaccines for the prevention of infectious diseases: regulatory considerations

The document on Evaluation of the quality, safety and efficacy of messenger RNA vaccines for the prevention of infectious diseases: regulatory considerations, is open for public comments on the WHO website:  (scroll down to the right-hand you will find “Call for comments”.)

The direct link to the document is :

Please use the WHO Comment Form to provide your comments:


Comments should be sent to Dr. Tiequn Zhou at no later than 17 September 2021.  



Anvisa is reelected member of the ICH Management Committee

Anvisa was reelected this Thursday morning (June 3), as a member of the Management Committee of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use – ICH . The decision was made by the ICH Assembly, with the presence of regulatory authorities and industrial associations from around the world.

The full article is available at:



WHO: Medical Product Alert N°2/2021: Falsified COVID-19 Vaccine BNT162b2

Falsified COVID-19 Vaccine BNT162b2 identified in the WHO region of the Americas

26 March 2021

Medical product alert
Reading time: 2 min (443 words)

Alert Summary

This WHO Medical Product Alert refers to falsified COVID-19 Vaccine identified as “BNT162b2” detected in Mexico in February 2021 and recently confirmed as falsified to the WHO. The falsified product was supplied and administered to patients outside authorized vaccination programs.

This falsified COVID-19 Vaccine may still be in circulation in the region and may continue to be offered to patients outside authorized vaccination programs.

Laboratory analysis of the contents of the falsified products is pending and this Alert will be updated as soon as results are available.

Genuine COVID-19 Vaccine BNT162b2 is indicated for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus, in individuals 16 years of age and older. The use of genuine COVID-19 vaccines should be in accordance with official guidance from national regulatory authorities.

Falsified COVID-19 vaccines pose a serious risk to global public health and place an additional burden on vulnerable populations and health systems. It is important to identify and remove these from circulation.

The product identified in this alert is confirmed falsified on the basis that it deliberately/fraudulently misrepresents identity, composition, or source:

  • The genuine manufacturer of COVID-19 Vaccine BNT162b2 confirmed they did not manufacture the product.
  • The batch number and expiry dates are falsified.
  • The glass vials and label are different from genuine COVID-19 Vaccine BNT162b2 vials.


Table 1: Products subject of WHO Medical Product Alert N°2/2021

Table 1. Falsified COVID-19 Vaccine details

Advice to regulatory authorities and the public

WHO requests increased vigilance within the supply chains of countries and regions likely to be affected by these falsified products. Increased vigilance should include hospitals, clinics, health centers, wholesalers, distributors, pharmacies, and any other suppliers of medical products.

All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. Seek advice from a healthcare professional in case of doubt.

If you are in possession of the above products, please do not use them.

If you have used these products, or you suffered an adverse reaction/event having used these products, you are advised to seek immediate medical advice from a qualified healthcare professional and to report the incident to the National Regulatory Authorities/National Pharmacovigilance Centre.

National regulatory/health authorities are advised to immediately notify WHO if these products are discovered in their country. If you have any information concerning the manufacture, distribution, or supply of these products, please contact the WHO Global Surveillance and Monitoring System via


Table 2: Photographs of products subject of WHO Medical Product Alert N°2/2021

Table 2. Falsified COVID-19 Vaccine images


WHO Global Surveillance and Monitoring System

for Substandard and Falsified Medical Products

For more information, please visit the web pages of the WHO Global Surveillance and Monitoring System or Email:



31st edition of the RedETSA Webinars – Healthcare cost base

Dear all,

We are pleased to invite you to the 31st  edition of the RedETSA Webinars program, next Friday, March 19, at 2pm, Washington DC time.  

Alfredo Palacios, from the Institute for Clinical Effectiveness and Health Policy (IECS), Argentina,  will give a presentation on “Healthcare cost base.The session will take place in Spanish, without translation. 

The WebEx link that we will use is the following:

Please feel free to extend this invitation to all those who might be interested.

Best regards,

RedETSA Secretariat


Anvisa is approved for Pharmaceutical Inspection Co-operation Scheme – PIC/S

On Monday (30/11), Anvisa was formally informed of the successful completion of the Agency’s process of adhering to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Anvisa will become the 54th member of the international initiative in pharmaceutical inspection, and will have the international recognition of the excellence of inspections in Good Manufacturing Practices (GMP) of medicines and pharmaceutical inputs for human use.


WHO: Mask use in the context of COVID-19: interim guidance, 1 December 2020

This document, which is an update of the guidance published on 5 June 2020, includes new scientific evidence relevant to the use of masks for reducing the spread of SARS-CoV-2, the virus  that causes COVID-19, and practical considerations. It contains updated evidence and guidance on the following:
• mask management;
• SARS-CoV-2 transmission;
• masking in health facilities in areas with community, cluster and sporadic transmission;
• mask use by the public in areas with community and cluster transmission;
• alternatives to non-medical masks for the public;
• exhalation valves on respirators and non-medical masks;
• mask use during vigorous intensity physical activity;
• essential parameters to be considered when manufacturing non-medical masks (Annex).

Mask use in the context of COVID-19: interim guidance, 1 December 2020 (