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Industry Calls For Canadian Pricing Guideline Consultation To Be Suspended

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

North America Canada

Canada Consults On Real-World Evidence Guidance For HTAs And Regulators

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

North America Canada

Saudi FDA Finalizes Approach To Commercial Info In Public Assessment Reports

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

Saudi Arabia Guidance Documents

WHO Gives Strong Backing To Antimalarial Combo As New Resistance Strategy Kicks Off

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.

International Middle East and Africa

Brazilian Regulator Consults On Improving Rules For Registering Biosimilars

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

South America Brazil

Gavi Reveals Plans To Boost Africa’s Vaccine Production

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.

Middle East and Africa Vaccines

Global Pharma Guidance Tracker – October 2022

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

Canadian Guideline Homes In On Excessive Medicine Pricing

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.

North America Canada

Global Pharma Guidance Tracker – September 2022

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.

Regulation International

Canada Addresses Diversity In Clinical Trials With New Rule For Drug Filings

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

Clinical Trials Canada

Brazilian HTA To Adopt Cost-Effectiveness Thresholds

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

South America Brazil

New Consortium Pledges To Boost Supply Of COVID-19 Antivirals In LMICs

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.

International Middle East and Africa
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