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Saint Vincent and the Grenadines Achieves Full Membership in the WHO PIDM

Saint Vincent and the Grenadines (SVG) has recently became Full Member of the WHO Programme for International Drug Monitoring (PIDM).  SVG joins three other CARICOM states as full members: Barbados, Jamaica and Suriname. The Programme was established in 1968, and consists of a group of more than 150 countries that work nationally and collaborate internationally to monitor any harm caused by medicines, to reduce the risks to patients and to establish worldwide pharmacovigilance standards and systems.

The Uppsala Monitoring Centre (UMC) has been responsible for the technical and operational aspects of the programme since 1978, and from October 2017, the Caribbean Regulatory System (CRS) of the Caribbean Public Health Agency (CARPHA) VigiCarib program began sharing reports from SVG with the UMC, which has contributed to achievement of full membership. As of April 2020, 99 case reports of suspected adverse drug reactions have been reported to the UMC via the CRS from the SVG Pharmacovigilance and Drug Information Centre, and SVG has become a leader in reporting in CARICOM.

CARICOM States with membership in the WHO PIDM

Full Members: Barbados, Jamaica, Saint Vincent and the Grenadines, Suriname

Associate Members: Antigua and Barbuda, Belize, British Virgin Islands, Dominica, Haiti, Grenada, Guyana, Saint Kitts and Nevis, Saint Lucia

Further information at https://www.who-umc.org/global-pharmacovigilance/who-programme-for-international-drug-monitoring/who-programme-members/ and https://carpha.org/What-We-Do/CRS/VigiCarib

 

 
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PAHO: Guidance and strategies to streamline the ethics review and oversight of COVID-19-related research

In a prior publication PAHO has stressed the moral obligation to do research about COVID-19 as quickly as possible to produce the evidence that is needed to respond to the pandemic.

This new publication provides guidance and strategies to streamline the ethics review and oversight of COVID-19-related research with human subjects. It is available at: https://www.paho.org/en/documents/guidance-and-strategies-streamline-ethics-review-and-oversight-covid-19-related-research.

In an upcoming publication a template of standard operating procedures for ethics review in emergency situation, which committees can adapt to their contexts and adopt will be given.

 
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Annotated Medicine and Devices Lists

PAHO has launched the MedList, an annotated medicine and device lists portal that provides evidence summaries based on a context and question about a medicine clinical use.

Here you can find scientific and technological information related to COVID-19 on medicines and other health technologies, explore the international database of grade guidelines, explore WHO prequalified vaccines tool, and access BRISA, the database for technology assessment reports.

Click here to access the Search engine to access scientific & technological information related to COVID-19

 

 
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FDA: actions related to COVID-19

The latest information on FDA actions related to COVID-19 are available at: https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19#new

At-a-glance: FDA COVID-19 response summary

Medical Devices:

FDA posted a new webpage with frequent questions and answers on importing medical devices during the COVID-19 pandemic

Drug Shortages: FDA updates its webpage on COVID-19 drug shortages responses 

Hand Sanitizers containing methanol: List of recalled hand-sanitizers that contain undeclared methanol as ingredient

Emergency Use Authorizations (EUA):

Product-Specific Guidance:

Abbreviated New Drug Applications (ANDA): Albuterol sulfate inhalation solution 0.021% and 0.042%

Guidelines:

Serology tests for COVID-19 : The FDA issued an  note about the importance of serology tests for  COVID-19 as well as the situation about firms falsely claiming that their serological tests are FDA approved or authorized, or falsely claiming that they can diagnose COVID-19

Reference links for fraudulent COVID-19 products:

R&D: https://www.fda.gov/medical-devices/database-reference-grade-microbial-sequences-fda-argos/fda-argos-sars-cov-2-reference-grade-sequence-data

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Coronavirus Treatment Acceleration Program (CTAC)

Adverse Event Reporting for Medical Devices under EUA or discussed in COVID-19 related guidance document.

Thermal Imaging Systems (Infrared Thermographic Systems / Thermal Imaging Cameras)

FDA encourages recovered patients to donate plasma for development of blood-related therapies

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The Center for Drug Evaluation and Research (CDER) launch a webpage with activities and information related to COVID-19: https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs

 
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ANVISA: actions related to COVID-19

  • General actions:

The Brazilian National Regulatory Authority, Anvisa, is carrying out several regulatory and informative actions to address the international public health emergency related to SARS-CoV-2 (a new type of coronavirus), which causes COVID-19. All related information is gathered on the link: http://portal.anvisa.gov.br/coronavirus

Report on ANVISA’s actions to fight the pandemic  (NEW)

  • IVD for COVID-19

The COVID-19 IVD  list is daily updated and is available here 

  • Regulations and guidance:

The list of specific regulations and guidance is regularly updated and available at http://portal.anvisa.gov.br/coronavirus/regulamentos

 
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FDA: COVID-19 regulatory update

 

 
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USP: resources and information related to COVID-19

The United States Pharmacopeia (USP) has made available some resources and information related to COVID-19 to the public:

 

 

 
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PAHO: The imperative to catalyze COVID-19 ethical research – Tuesday March 31 2:00 – 3:30 pm, Washington D.C. time (In English)

We invite you to participate in this virtual seminar to present and discuss PAHO’s ethics guidance for COVID-19 research available at: https://www.paho.org/en/documents/ethics-guidance-issues-raised-novel-coronavirus-disease-covid-19-pandemic.

To participate follow this link: https://paho.webex.com/paho/onstage/g.php?MTID=eb1e5b00997fab7e37c834c5d35d9ad3f

Tuesday March 31 2:00 – 3:30 pm, Washington D.C. time (In English)

We are waiting for you.

PANDRH Secretariat