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:



COVID-19 highlights need for strengthening national regulatory authorities in Latin America and the Caribbean

PAHO report: COVID-19 highlights need for strengthening national regulatory authorities in Latin America and the Caribbean
Study draws lessons for the region from the six national regulatory authorities of reference in Argentina, Brazil, Chile, Colombia, Cuba, and Mexico.

Washington, D.C., April 26, 2021 (PAHO) The COVID-19 pandemic has demonstrated the urgent need for strengthening national regulatory authorities in Latin America and the Caribbean to ensure the safety and effectiveness of new medicines and medical products, a new report by the Pan American Health Organization (PAHO) asserts.

“During the pandemic, we have watched the rapid deployment of clinical trials, the introduction of new and repurposed treatments, and now the development and use of new vaccines, many based on innovative and groundbreaking technological platforms,” said PAHO Assistant Director Jarbas Barbosa. “Throughout these processes, the role of regulatory authorities as independent and science-based institutions has proven more critical than ever.”

The report shows that national regulatory authorities vary dramatically in their capacity to evaluate medicines and medical products. The report draws lessons for improvement from six national regulatory authorities in the region, which PAHO has designated as National Regulatory Authorities of Reference (NRAr). These authorities are ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), INVIMA (Colombia), CECMED (Cuba), and COFEPRIS (Mexico).

Key findings include:

  • Robust regulatory capacities result from expansive legal and organizational frameworks, which give NRArs technical independence and strong mandates to supervise and sanction the pharmaceutical product approvals within their jurisdictions.
  • Recent reforms in national regulatory authorities have brought important improvement in access to medicines and transparency within the authorities.
  • Financial and human resources for national regulatory authorities have remained relatively static over the last five years in Latin America while the pharmaceutical market has increased both in value, volume and medical product complexity.
  • The manufacture of increasingly complex medical products requires stronger surveillance and control. Post-marketing surveillance and pharmacovigilance is a potential weakness of systems.
  • Advances in national regulatory authorities have helped catalyze improvements in other countries and regions. The creation of the Caribbean regulatory system and the Central American joint working system reflect an improvement of regulatory capacity.

The report raises concerns about the “limited or complete lack of legal and organizational frameworks for regulatory systems in a number of countries.”  It encourages countries with less capacity to rely, whenever possible, on evaluations and approvals already completed by one or more of the NRArs.

The report also highlights emergency measures that authorities have implemented since the beginning of the COVID-19 pandemic to improve access to health technologies essential for response and mitigation. “Yet the pursuit of accelerating access, while safeguarding the safety, effectiveness and quality of the products, created tensions and pressures within national regulatory authorities,” Dr. Barbosa said.

In 2010, PAHO member countries adopted a resolution calling for strengthening regulatory systems, which was the first of its kind for the World Health Organization (WHO).  The resolution established regulatory systems as a public health priority and underscored the need to ensure that medical products comply with international standards and are affordable and accessible.

“The Region of the Americas has made great progress in strengthening national regulatory authorities over the past decade, but work must continue,” Dr. Barbosa said.  “Strengthening regulatory systems takes time and commitment, and requires national leadership for sustainability.”

“Regulatory System Strengthening in the Americas” (English)
“Fortalecimiento del systema regulatorio en las Américas”  (Spanish)
Virtual launch of “Regulatory System Strengthening in the Americas” (Original audio)
Virtual launch of “Regulatory System Strengthening in the Americas” (English)
Lanzamiento virtual de “Fortalecimiento del sistema regulatorio en las Américas” (Spanish)

[Original press at PAHO’s website]


55th Report – WHO Expert Committee on Specifications for Pharmaceutical Preparations

The 55th WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) is now available at: It will be included on the agenda and presented to the 149th session of the WHO Executive Board.

Important to mention that the chapter 9  “Regulatory guidance and model schemes”  of such document includes:

  • WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce (page 205)
  • Good reliance practices in the regulation of medical products (page 237)
  • Good regulatory practices in the regulation of medical products (page 269)
  •  Update on WHO-listed authorities (page 40)




European Medicines Agency notification on new electronic Certificates of Pharmaceutical Products

In March 2020, the European Medicines Agency (EMA) informed that it would no longer provide printed Certificates of Pharmaceutical Products (CPP) but only electronically signed and authenticated ones, that would enable EMA to continue to be able provide certificates during the COVID-19 pandemic. The Agency considers electronic CPPs as the permanent way of issuing certificates.

EMA published a guidance on the format and safety features of the electronic certificates, as well on as measures to help regulatory authorities of importing countries confirm their validity. It also produced an official letter with information that might be useful for regulators when handling the electronic certificates.

On the use of electronic CPPs, WHO agrees with this initiative, which does not contradict the current guidelines. The Organization recommends other regulators issuing certificates consider this approach too, and urges regulators receiving certificates to accept the electronic signature.



WHO: Public consultation for review of draft COVID-19 vaccines: Safety Surveillance manual

The WHO has published the draft “COVID-19 Vaccines: Safety Surveillance Manual” for public consultation. Comments and suggestions shall be sent to, no later than 13 November 2020, 12 PM CET.

This COVID-19 vaccine safety surveillance manual has been developed upon recommendation and guidance of Global Advisory Committee on Vaccine Safety (GACVS) members, as well as by experts incorporating current and available information critical to all stakeholders when COVID-19 vaccines will be introduced.

Such manual provides relevant guidance prior to, during and after COVID-19 vaccine introduction for governments, global, regional and national staff from immunization programmes, regulatory authorities, partners and pharmacovigilance centers as well as marketing authorization holders.

Further information at:



Work to develop a COVID-19 vaccine is faster than ever but safety and efficacy processes remain unchanged


WORLD HEALTH ORGANIZATION                       

News and Public Information

News release


Work to develop a COVID-19 vaccine is faster than ever but safety and efficacy processes remain unchanged, PAHO Director says 

However, while spikes in cases continue in the Region, countries must ensure a sustained response until a vaccine arrives. 

Washington D.C., October 21, 2020 (PAHO) – While the Americas urgently awaits a breakthrough, the Pan American Health Organization (PAHO) will only support the distribution of a vaccine that has proven to be safe and effective in clinical trials, reviewed by National Regulatory Authorities and recommended by the World Health Organization (WHO), PAHO Director Carissa F Etienne, said today.

“It is important to emphasize that while we’re working to develop a vaccine faster than ever before, the process to guarantee its safety and efficacy is unchanged,” Etienne told a press briefing in Washington, DC. She noted that there is a pipeline of more than 180 vaccine candidates under study, with 11 in phase III clinical trials.

What has changed “is the unprecedented attention on the vaccine development process,” she added, highlighting the “over-abundance of information from a number of sources, some less reliable than others and not based on science, which has led to confusion and misinformation around vaccine safety.”

The PAHO Director emphasized that vaccines are designed and manufactured with safety in mind. Once a COVID-19 vaccine proves safe and effective in a clinical trial, regulatory agencies thoroughly evaluate the data prior to granting approvals and WHO will also oversee an independent review process before granting its own recommendation.

“How we communicate about COVID-19 will make our ability to control the pandemic,” she said, calling for countries, the media, regulatory authorities, the private sector and the scientific community to come together to provide the public with “clear, concise and science-based information about a future COVID-19 vaccine.”

Access to vaccines 

An important factor to establish trust in the new vaccines is to ensure their accessibility to all countries, and PAHO is supporting countries to gain access to these vaccines through the COVAX facility, Etienne noted.

“Virtually every country in Latin America and the Caribbean has joined or is in the process of joining the facility,” she said, and countries are taking legal and budgetary steps needed to participate in this innovative global partnership. “We are actively collaborating with financial institutions, like the Inter-American Development Bank, to support countries in our region access the funding needed to purchase vaccines through the COVAX Facility when they are available. Etienne added.

“PAHO’s Revolving Fund, with more than 40 years of experience providing affordable and quality vaccines to countries in Latin American and the Caribbean, will be, along with UNICEF, the purchase mechanism for the COVAX facility,” she said.

 In the Caribbean, 11 countries will receive financial support for initial payments to join the COVAX facility, she said, in collaboration with the Caribbean Public Health Agency and the European Union.

COVID-19 in the Americas 

The PAHO Director noted that there have been over 40 million cases and over 1.1 million deaths worldwide due to COVID-19, including 18.9 million cases in the Region of the Americas and over 610,000 deaths as of October 20. “Across our Region, around 100,000 people continue to test positive for COVID-19 every day,” Etienne said.

Trends show cases rising in the United States and Canada and plateauing across Central America, while most new cases in the Caribbean are related to non-essential international travel, Etienne noted.

These spikes show that while the region is “hard at work preparing for a vaccine, we must also keep a strong and steady course to continue fighting the virus without one.”

She urged all countries to “prioritize a transparent and proactive communications approach for COVID-19. The people of our region crave clear guidance. Communicating effectively and consistently about what they can do to protect themselves and avoid infection remains vital.”

Etienne added that “Testing, treating and isolating cases, as well as tracing contacts are all part of a good surveillance strategy and too few countries are doing this well in our region. It is as important now as it was in April. And it will be even more important once we have a vaccine.”

Further information at:,Work%20to%20develop%20a%20COVID%2D19%20vaccine%20is%20faster%20than,remain%20unchanged%2C%20PAHO%20Director%20says&text=However%2C%20while%20spikes%20in%20cases,response%20until%20a%20vaccine%20arrives.


The Pan American Health Organization (PAHO) works with the countries of the Americas to improve the health and quality of life of its population. Founded in 1902, it is the world’s oldest international public health agency. It serves as the Regional Office of WHO for the Americas and is the specialized health agency of the Inter-American system.




For the first time CARPHA-CRS recommends a medicine for rare disease

The Caribbean Public Health Agency’s Caribbean Regulatory System (CARPHA – CRS) has issued the first recommendation of a medicine to treat a rare disease.

To date, more than 130 medicines and other health technologies have been recommended by CARPHA-CRS to CARICOM Member States.

Further information is available at



PAHO has published official Spanish version of the English original: WHO GLOBAL BENCHMARKING TOOL (GBT) FOR EVALUATION OF NATIONAL REGULATORY SYSTEMS OF MEDICINES AND VACCINES that is available at


The English version of the GBT, developed by WHO can be found at

All queries related to GBT should be sent to WHO Regulatory Systems Strengthening Team at