Washington, DC, 21 December (PAHO) – In an effort to increase equitable access to COVID-19 therapeutics, the Pan American Health Organization (PAHO) delivered more than 11,000 vials of a medication to improve treatment for severe and critically ill COVID-19 patients in 15 Latin American and Caribbean countries.  

Countries that have received the PAHO donation of tocilizumab since mid-September are Belize, Bolivia, Dominica, Dominican Republic, El Salvador, Grenada, Guyana, Haiti, Jamaica, Nicaragua, Peru, St. Lucia, St. Vincent and the Grenadines, Suriname and Venezuela. Panama expects to receive it soon. 

The drug, tocilizumab, has been shown to reduce deaths in hospitalized patients with severe or critical COVID-19, who are rapidly deteriorating or need increased levels of oxygen, and who have a significant inflammatory response.   

The purchase, worth over US$2 million, was procured by PAHO and supported by the Government of the United States. 

For more information go to https://www.paho.org/en/news/21-12-2022-paho-makes-covid-19-therapeutic-available-16-countries

Geneva, 23 January 2023 – WHO is releasing an urgent call to action to countries to prevent, detect and respond to incidents of substandard and falsified medical products.
Over the past four months, countries have reported on several incidents of over-the-counter cough syrups for children with confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol (EG). The cases are from at least seven countries, associated with more than 300 fatalities in three of these countries. Most are young children under the age of five. These contaminants are toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even taken in small amounts, and should never be found in medicines.
Based on country reports, WHO has issued three global medical alerts addressing these incidents. The  Medical Product Alert N°6/2022 on 5 October 2022 focused on the outbreak in the Gambia, Medical Product Alert N°7/2022 on 6 November 2022 focused on Indonesia, and Medical Product Alert N^o1/2023 on 11 January 2023 focused on Uzbekistan.
WHO’s medical product alerts were rapidly disseminated to the national health authorities of all 194 WHO Member States.  These medical product alerts requested, inter alia: (a) the detection and removal of contaminated medicines from circulation in the markets, (b) increased surveillance and diligence within the supply chains of countries and regions likely to be affected, (c) immediate notification to WHO if these substandard products are discovered in-country; and otherwise inform the public of the dangers and toxic effects of the substandard medicines at issue.
Since these are not isolated incidents WHO calls on various key stakeholders engaged in the medical supply chain to take immediate and coordinated action.

For more information go to WHO urges action to protect children from contaminated medicines

FDA’s curriculum materials are intended to help educate students in health care professional degree programs, for medicine, nursing, physician assistants, and pharmacy, as well as practicing professionals, to improve understanding of biosimilar and interchangeable biosimilar products and the regulatory approval pathway in the United States. For more information go to https://www.fda.gov/drugs/biosimilars/curriculum-materials-health-care-degree-programs-biosimilars

https://www.paho.org/en/news/10-12-2021-national-regulatory-authorities-will-play-key-role-stepping-vaccines-manufacturing

https://www.paho.org/en/events/10th-conference-pan-american-network-drug-regulatory-harmonization

The COVID-19 pandemic posed a challenge for health systems that had to take regulatory decisions to ensure timely access to medicines and other health technologies, including vaccines, blood and derivatives, medical devices, reagents and in vitro diagnostics that are quality, safe and effective to the population.

The 10^th edition of the Conference of the Pan American Network for the Drug Regulatory Harmonization (PANDRH) provides a virtual space to discuss the contribution of regulatory systems in the response to the pandemic, as well as the lessons learned and post-COVID-19 regulatory challenges with PANDRH members and experts from the Region of the Americas and worldwide.

The Conference will take place entirely online on December 6, from 9:30 to noon, December 8 from 9 to 11am, and December 10, from 9 to 11:30am (Washington, D.C. time) and requires advance registration. Sessions will be held in English, Portuguese and Spanish, with the option of simultaneous translation in these languages, as well as in French.

Please register HERE

The quotas to participate in this Conference are limited, so PANDRH Secretariat will prioritize the registrations of representatives of the national regulatory authorities of the Americas region, representatives of the pharmaceutical industry members of ALIFAR and FIFARMA; of economic integration organizations such as CARICOM, MERCOSUR, NAFTA, ALADI, Andean Community; consumer groups; academics; representatives of regional professional associations; and from other groups interested in harmonization and regulatory convergence initiatives.

Note: quotas will be granted to representatives of pharmaceutical industries not affiliated to ALIFAR or FIFARMA as long as they remain vacant after the registration of those considered priority.

*Further information and agenda of the Conference, please click here