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Health Canada Ponders UK Model On Easing Biosimilar Study Requirements

Discussions are ongoing at Health Canada on the feasibility of adopting the UK model of easing clinical study requirements for biosimilars, said director general Celia Lourenco at a recent event. Meanwhile, the US FDA’s stance is unchanged for now.

Regulation Biosimilars

Coronavirus Notebook: UK Reports Impressive Booster Results, Drones Deliver Vaccines In Africa

Emergex is preparing to begin a Phase I study of its T-cell priming vaccine, RedHill BioPharma has completed enrolment in a Phase II/III study of upamostat, and Australia is assessing Moderna’s Spikevax for use in 6-11 year olds.

United Kingdom Australia

US ‘Lags Behind’ EU & Canada On Clinical Data Transparency

The US Food and Drug Administration has proactively released data for just one drug, compared with data released for over 100 drugs by the European Medicines Agency and just over 70 drugs by Health Canada, according to a study that compared the accessibility and comprehensiveness of the data that the three regulators proactively or reactively disclose.

Europe North America

Global Pharma Guidance Tracker – October 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

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
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