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Canadian Court Upholds New Drug Price Comparison Basket – With Caveats

A Canadian court has dismissed an appeal brought by industry challenging new pricing rules that introduce a revised basket of reference countries as part of cost-containment measures.

North America Canada

Canada’s Controversial Pricing Guidelines Suspended

The implementation of new pricing guidelines that are unpopular with the pharmaceutical has been put on hold, to the relief of the pharmaceutical industry.

North America Canada

Ethiopian Regulators To Take Part In Work Of European Pharmacopoeia

Ethiopia is the latest African country that the European Pharmacopoeia Commission has accepted as an observer.

Ethiopia Europe

Global Pharma Guidance Tracker – December 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

Canada Wants More Agility And Alignment In Drug Regulations

The Canadian regulator has proposed several changes to current drug regulations to deliver on its modernization commitments and leverage long-standing policies and practices.

Canada Regulation

Global Pharma Guidance Tracker – November 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

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
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