Report on the review of regulatory flexibilities/agilities as implemented by National Regulatory Authorities during COVID-19

The ICMRA and WHO joint report on the implemented regulatory flexibilities in COVID-19 framework has been published

The report brings together different regulatory flexibilities/agilities that National Regulatory Authorities (NRAs) had implemented to ensure that there was continuity with regulatory oversight on routine functions while allowing for timely development and approvals of medical products for Covid-19.

The main objective of this report is to foster transparency and information sharing of practices among NRAs, besides providing models or examples of practices that other limited resourced NRAs could consider and potentially adopt and adapt to their regulatory systems within the respective national legal frameworks.

The authors inform that the report contains specific limitations on the scope of considered products, sources of information, period of review of flexibilities, context of application and effectiveness of these flexibilities.


Unmasking safety signals in an ‘Infodemic’ – a Pharmacovigilance Workshop

World Health Organization

Regulation and Prequalification (RPQ)

When: 6 DECEMBER 2021 14:00 (CET/local time Geneva)
Topic: Unmasking safety signals in an infodemic
Link below to join the webinar:
Meeting ID: 942 8343 9124
Password: 1NfoD3+c


WHO recommends groundbreaking malaria vaccine for children at risk

Historic RTS,S/AS01 recommendation can reinvigorate the fight against malaria


The World Health Organization (WHO) is recommending widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine among children in sub-Saharan Africa and in other regions with moderate to high P. falciparum malaria transmission. The recommendation is based on results from an ongoing pilot programme in Ghana, Kenya and Malawi that has reached more than 800 000 children since 2019.

“This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Using this vaccine on top of existing  tools to prevent malaria could save tens of thousands of young lives each year.”

Malaria remains a primary cause of childhood illness and death in sub-Saharan Africa. More than 260 000 African children under the age of five die from malaria annually.

In recent years, WHO and its partners have been reporting a stagnation in progress against the deadly disease.

“For centuries, malaria has stalked sub-Saharan Africa, causing immense personal suffering,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “We have long hoped for an effective malaria vaccine and now for the first time ever, we have such a vaccine recommended for widespread use. Today’s recommendation offers a glimmer of hope for the continent which shoulders the heaviest burden of the disease and we expect many more African children to be protected from malaria and grow into healthy adults.”

WHO recommendation for the RTS,S malaria vaccine

Based on the advice of two WHO global advisory bodies, one for immunization and the other for malaria, the Organization recommends that:

WHO recommends that in the context of comprehensive malaria control the RTS,S/AS01 malaria vaccine be used for the prevention of P. falciparum malaria in children living in regions with moderate to high transmission as defined by WHO.  RTS,S/AS01 malaria vaccine should be provided in a schedule of 4 doses in children from 5 months of age for the reduction of malaria disease and burden.

Summary of key findings of the malaria vaccine pilots

Key findings of the pilots informed the recommendation based on data and insights generated from two years of vaccination in child health clinics in the three pilot countries, implemented under the leadership of the Ministries of Health of Ghana, Kenya and Malawi. Findings include:

  • Feasible to deliver: Vaccine introduction is feasible, improves health and saves lives, with good and equitable coverage of RTS,S seen through routine immunization systems. This occurred even in the context of the COVID-19 pandemic.
  • Reaching the unreached: RTS,S increases equity in access to malaria prevention.
    • Data from the pilot programme showed that more than two-thirds of children in the 3 countries who are not sleeping under a bednet are benefitting from the RTS,S vaccine.
    • Layering the tools results in over 90% of children benefitting from at least one preventive intervention (insecticide treated bednets or the malaria vaccine).
  • Strong safety profile: To date, more than 2.3 million doses of the vaccine have been administered in 3 African countries – the vaccine has a favorable safety profile.
  • No negative impact on uptake of bednets, other childhood vaccinations, or health seeking behavior for febrile illness. In areas where the vaccine has been introduced, there has been no decrease in the use of insecticide-treated nets, uptake of other childhood vaccinations or health seeking behavior for febrile illness.
  • High impact in real-life childhood vaccination settings: Significant reduction (30%) in deadly severe malaria, even when introduced in areas where insecticide-treated nets are widely used and there is good access to diagnosis and treatment.
  • Highly cost-effective: Modelling estimates that the vaccine is cost effective in areas of moderate to high malaria transmission.

Next steps for the WHO-recommended malaria vaccine will include funding decisions from the global health community for broader rollout, and country decision-making on whether to adopt the vaccine as part of national malaria control strategies.

Financial support

Financing for the pilot programme has been mobilized through an unprecedented collaboration among three key global health funding bodies: Gavi, the Vaccine Alliance; the Global Fund to Fight AIDS, Tuberculosis and Malaria; and Unitaid.

Note to editors:

  • The malaria vaccine, RTS,S, acts against P. falciparum, the most deadly malaria parasite globally, and the most prevalent in Africa.
  • The Malaria Vaccine Implementation Programme is generating evidence and experience on the feasibility, impact and safety of the RTS,S malaria vaccine in real-life, routine settings in selected areas of Ghana, Kenya and Malawi.
  • Pilot malaria vaccine introductions are led by the Ministries of Health of Ghana, Kenya and Malawi.
  • The pilot programme will continue in the 3 pilot countries to understand the added value of the 4th vaccine dose, and to measure longer-term impact on child deaths.
  • The Malaria Vaccine Implementation Programme is coordinated by WHO and supported by in-country and international partners, including PATH, UNICEF and GSK, which is donating up to 10 million doses of the vaccine for the pilot.
  • The RTS,S malaria vaccine is the result of 30 years of research and development by GSK and through a partnership with PATH, with support from a network of African research centres.
  • The Bill & Melinda Gates Foundation provided catalytic funding for late-stage development of RTS,S between 2001 and 2015.


Source: WHO


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: