Be-cause Health & QUAMED literature updates Ref: World Health Organization. Regulatory guidance for assessment and management of applications for marketing authorization of oxytocin. WHO 2021. ISBN 978-92-4-002213-3 (electronic version). Dear Friends, Today, I would like to share a WHO regulatory document concerning the quality of oxytocin-containing products. You can download it at this link: https://www.who.int/publications/i/item/9789240022133 ...
Dr. Prosper Hiag, who facilitated our last QUAMED member webinar, appealed to drug regulators in Africa at a regional workshop in Lagos, Nigeria. He asked them to enact laws to guide the practice of internet pharmacy across the continent. The event was held under the theme: “Technological innovations for pharmacy in Africa amidst the Covid-19 ...
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 ...
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