Other Countries

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.

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.

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.

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

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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.

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.

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.

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.

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.

Pharmaceutical companies have been invited to take part in technology transfer for vaccines.