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Regulatory Reliance Behind The Success Of African COVID-19 Vaccine Approvals
Regulatory reliance and work-sharing are becoming increasingly popular as a way of avoiding duplication and speeding up drug and vaccine assessments, but while there are many benefits, regulators should also be aware of some potential pitfalls, delegates at the TOPRA annual symposium heard this week.
Cuban COVID-19 Vaccines To Come Under WHO Scrutiny
The Cuban government has approved the country’s home grown COVID-19 vaccine for emergency use in children, while Mexico is poised to authorize another Cuban vaccine.
GMP Deficiencies Lead Brazil To Target Sinovac’s Chinese COVID-19 Vaccine Plant
Having decided to suspend 12 million doses of Sinovac’s coronavirus vaccine, Brazil’s regulatory agency says it will need to make its own on-site assessment of conditions at the Chinese facility that makes the product.
Global Pharma Guidance Tracker – August 2021
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
New Initiative Aims To Drive Local COVID-19 Vaccine Production in Latin America
Pharmaceutical companies have been invited to take part in technology transfer for vaccines.
Brazil Considers Easier Path For Compulsory Licensing
A bill amending Brazilian patent law to make compulsory licensing easier has passed the senate but still must be signed off by president Jair Bolsonaro.
Coronavirus Notebook: Egypt Boosts Vaccine Supply, Fenofibrate Shows ‘Astounding’ Results In Treating COVID-19
The European Medicines Agency has OKd more production sites for the manufacture of vaccines destined for the EU, the US and Australia have warned against taking ivermectin to protect against SARS-CoV-2 infection, and Italy has dismissed some ‘fake news’ about vaccine approvals.
Coronavirus Notebook: Australia OKs GSK’s Sotrovimab For COVID-19, Iran Takes SpikoGen Vaccine Into Phase III
Bavarian Nordic is testing the potential of its ABNCoV2 vaccine as a booster dose for people with previous infection or vaccination. Brazil has received requests from Pfizer/BioNTech and AstraZeneca to trial vaccines as booster doses, and has asked for more immunogenicity data on SinoVac’s CoronaVac.
Coronavirus Notebook: Janssen Vaccine Effective Against Two Virus Variants In South Africa Study, But Gets EU Thrombocytopenia Warning
Data show that more than 480 million COVID-19 vaccines have now been administered in the EU/European Economic Area, with Malta, Iceland and Ireland leading the way in the percentage of people now fully vaccinated.
Global Pharma Guidance Tracker – July 2021
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Drug Sponsors Invited To Trial Pre-Submission Meetings With South African Agency
The South African Health Products Regulatory Authority is planning to introduce meetings with drug sponsors that can help identify and resolve potential shortcomings in marketing applications before they are submitted for evaluation.
Africa Vaccine Supplies To Rise After ‘Worst Pandemic Week Ever’
Despite an alarming surge in coronavirus cases across the African continent, there are hopes of a substantial rise in vaccine supplies in the coming months.
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