FDA has issued an Immediately In Effect Guidance for laboratories and commercial manufacturers to help accelerate the use of test they develop in order to achieve more rapid and widespread testing capacity. The guidance also provides FDA’s recommendations regarding validation of COVID-19 tests (see section V of the guidance). The guidance can be found at the following link:
FDA maintains a listing of the tests that are authorized for COVID-19 testing on this webpage: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019. There are currently 9 FDA-authorized tests for COVID-19. Under the description of each test there are links to the FDA authorization letter, a package insert which describes the studies used to verify/validate the test and fact sheets for patients and physicians.
FDA also announced that they would be taking steps to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. This action allows certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-and-cdc-take-action-increase-access-respirators-including-n95s
Announcement about Ibuprofen and COVID-19 (Washington, DC. 18 March, 2020)
Regarding information that appeared in the media about the risk of using ibuprofen in COVID-19 infections, between March 15 and March 18, 2020 the World Health Organization (WHO) and some regulatory authorities such as the European Medicines Agency (EMA), National Health Services (NHS) in the United Kingdom, Spanish Agency of Medicines and Medical Devices (AEMPS) in Spain, and the Health Products Regulatory (HPRA) in Ireland have stated that there is currently no evidence to support an aggravation of COVID-19 infection with ibuprofen or other NSAIDs.
In short and pending new data, we believe the approach suggested by the UK NHS is appropriate. It addresses the lack of evidence regarding harmful effects of ibuprofen on covid-19 infections and does not advise to discontinue ongoing treatments with this medicine but, if treatment is initiated, prioritizes the use of paracetamol to treat symptoms of the infection.
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 20201,152
0
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/
