European Medicine Agency (EMA) is aware of reports, especially on social media, which raise questions about whether non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen could worsen coronavirus disease (COVID-19).
There is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID‑19. EMA is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic.
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).
Coronavirus disease (COVID-19) is a new strain that was discovered in 2019 and has not been previously identified in humans.
Recently, Belize became an associate member of the WHO Program for International Drug Monitoring (WHO PIDM). The WHO PIDM helps countries with pharmacovigilance related activities, including provides software and analytical tools to report and analyze adverse events, provided the country can demonstrate to WHO that it has set up key elements for a successful pharmacovigilance program, including a national center, and can submit a certain number of high quality adverse event reports to WHO.
This accomplishment is the result of a focused effort on the part of the government of Belize and PAHO to strengthen regulatory functions including registration, pharmacovigilance, and post market surveillance. Regulatory strengthening in small countries like Belize can be especially challenging because small countries have fewer people to staff their agencies, small markets that do not incentivize strong industry engagement with regulation, and often times limited financing.
Belize’s strategy to improve its regulatory system makes use of new regional systems available to CARICOM countries, including CARPHA’s Caribbean Regulatory System, and its market surveillance reporting platform, VigiCarib. Belize has become a leader in CARICOM on regulatory strengthening initiatives.
PAHO’s approach to regulatory strengthening in small states, which is based on the PANDRH concept note that was presented at the PANDRH Conference in San Salvador, El Salvador, in 2018 has been published in BMJ Global Health.
Fernanda Lessa - 18:35, 26 de February de 20201,928
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The draft working document on “Revision of WHO GMP for sterile pharmaceutical products – a joint EU, PIC/S, WHO project”, is for public consultation due on 20 April 2020.
Additional information available at http://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/
Fernanda Lessa - 17:20, 14 de January de 20201,466
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National Regulatory Authorities (NRAs) of Argentina (ANMAT) and Brazil (ANVISA) made the first exchanges of medical devices audit reports using the Regulatory Information Secure Exchange (RISE) module.
Fernanda Lessa - 12:39, 14 de January de 20201,352
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Washington, D.C., 20 December 2019 (PAHO)-The National Regulatory Authorities (NRA) of Argentina (ANMAT), Colombia (INVIMA), Ecuador (ARCSA), El Salvador (DNM), Guyana (GAFDD), Mexico (COFEPRIS) and Venezuela (INHRR) have participated for the first time of the Single Medical Device Audit Program (MDSAP) Forum, held from 5-6 December 2019 in Washington D.C., USA.
