The collection and assessment of adverse reactions are important in the first decade after the marketing authorization of a drug. The information gathered in this period could help, for example, identify complications from its use that were unknown before its commercialization. However, when it comes to medicines that have been on the market for a ...
Be-cause Health & QUAMED literature updates Ref (1): US Pharmacopoeia, Increasing Transparency in the Medicines Supply Chain, 2021 Ref (2): US Pharmacopoeia, Global Public Policy Position: Key Elements to Building a More Resilient Supply Chain Dear Friend, The more diffuse and fragmented the supply chain is, the greater the risk that important information about the origin, production ...
USP has developed interesting material on quality and Covid-19. They include an infographic on production standards of Covid-19 vaccines and standards for quality assessment of COVID-19 vaccines. Follow these links for more information: Ensuring quality in monoclonal antibody development and COVID-19 Vaccine Quality Attributes Toolkits. Another great USP resource is the COVID-19 Vaccine Handling Guides. They have recently been ...
It is interesting to see that PIC/S has adopted guidance on “COVID-19 Risk Assessment for Routine On-Site Inspections” (PI 055-1). It entered into force on 15 July 2021. Please follow the following link to the PIC/S website “Publications” https://picscheme.org/en/news to download this document. It was nice to see that the larger suppliers that we have audited ...
A study done to assess the quality of timolol eye drops sold in Kinshasa, DRC has proved that the eye drops from Congolese and Indian manufacturers sold in Kinshasa are of substandard quality. This may reflect deficiencies in the manufacturers and local authorities charged with the regulation of the quality control and sale of pharmaceuticals.Read ...
On July 8 and July 9, Dr Patrick Lukulay and Dr Prosper Hiag presented a webinar to Quamed members on the renaissance of the African pharmaceutical industry: challenges, opportunities, and how the industry is poised to locally meet more of the health needs of African populations. More than 25 of our members participated in the ...
COVID-19 vaccines are vital interventions to help end the pandemic. However, issues with equitable global access, falsified, diverted and substandard (especially degraded) vaccines are highly likely to become increasingly global public health problems. Read the latest Medicine Product Quality Report on substandard and falsified (SF) COVID-19 vaccines, which summarise reports in the public domain including ...
On Wednesday the 9th of June, QUAMED held its 5th annual meeting. Our reports and plans were all adopted. We are grateful that most of our members could participate and we would like to thank ECHO and the Global Fund for their inspiring presentations. With frank exchanges and constructive questions, we feel that we are one step ...
South Africa’s struggle to increase access to anti-retroviral medications decades ago focused attention on the relationship between patent protection and high medicine prices. The COVID-19 pandemic has drawn greater attention to the cost of pharmaceutical technologies and the inequitable access to these. Globally this has raised concerns about the impact of the 1994 World Trade ...
Dear members, As we near our GA meeting set on the 9th June 2021, we’d like to kindly remind you all that it is crucial to check out our latest newsletter with the membership folder that includes all the important documents you’ll need for voting. As it is a statutory requirement, be sure to check it ...
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