Other Countries

IMC, the R&D-based pharmaceutical industry association in Canada, says the guideline will “exacerbate an already unpredictable regulatory environment.”

Canada’s health technology appraisal body is seeking feedback on guidance on the use of real-world evidence in decision making.

Saudi Arabia has explained what information on a drug’s review will be made public following a marketing authorization decision. 

Hot on the heels of its new antimalarial strategy, the World Health Organization has given a “strong” recommendation for the use of a fixed-dose artemisinin combination therapy from Shin Poong and the Medicines for Malaria Venture that should see it being more widely used in disease-endemic countries.

ANVISA, Brazil’s medicines regulator, is asking for feedback on the regulatory pathway for biosimilars.

Efforts are continuing to build up Africa’s ability to manufacture vaccines domestically in response to growing demand and calls to increase the security of supply across the continent.

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 draft guidelines outlining how Canada’s drug pricing authority will decide whether to investigate if a medicine is excessively priced are now out for consultation.

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.

Health Canada wants drug sponsors to start answering questions relating to disaggregated data for sex, age and race.

Brazil’s health technology assessment institute is to incorporate cost-effectiveness thresholds into its decision making.

Pfizer is donating 100,000 doses of its COVID-19 antiviral product, Paxlovid, to kick-start test-and-treat programs in lower income countries that will eventually use generic versions of the product.