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African Medicines Agency To Be Established In 2022

Enough African countries have now ratified the AMA treaty to allow it to come into force next month.

Middle East and Africa Cameroon

Global Pharma Guidance Tracker – September 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.

Guidance Documents Regulation

GSK Malaria Vaccine Gets Landmark Clearance For Use In Africa

Mosquirix is set for much wider availability in sub-Saharan Africa thanks to positive results from a pilot program in Ghana, Kenya and Malawi. The next step is deciding how to fund the vaccine’s rollout over the coming years.

Middle East and Africa Approvals

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.

International Regulation

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.

North America Cuba

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.

China Brazil

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.

Guidance Documents Regulation

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.

South America North America

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.

South America Brazil

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.

Australia Egypt

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.

Brazil Australia

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.

Europe South Africa
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