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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.
Additional information: https://www.who-umc.org/global-pharmacovigilance/who-programme-for-international-drug-monitoring/
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.
The publication is available at https://gh.bmj.com/content/5/2/e001912
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/
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.
Additional information here
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.
For additional information please click here.
The Pan American Health Organization invites you to celebrate Universal Health Day 2019, with the theme “Universal health: everyone, everywhere” – Compact on Primary Health Care for Universal Health 2030.
The PAHO Director, Carissa F. Etienne, and representatives from the academic field, NGOs, and U.S. authorities will participate of the event. Speakers will talk about achievements and new challenges to achieve Universal Health by 2030, with reference to the Compact 30.30.30: Primary Health Care for Universal Health.
When: Thursday, 12 December 2019
Time: 10 AM (EDT)
How: www.vimeo.com/pahotv
The International Pharmaceutical Regulators provide Training Manual on the Basic of Analytical Comparability of Biosimilar Monoclonal Antibodies (English, Spanish, Russian) at http://www.iprp.global/page/biosimilar-activities
The National Regulatory Authority from Brazil, ANVISA, was elected for the last vacant position at the Management Committee of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use – ICH.
For more information in Portuguese, please click here.
Interview with Analía Ines Porrás, during the 57 Directing Council, regarding the actual situation with organ transplantation.
