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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.
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.
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.
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.
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.
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.
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.”
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.
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.
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.
Brazilian Regulator Consults On Improving Rules For Registering Biosimilars
ANVISA, Brazil’s medicines regulator, is asking for feedback on the regulatory pathway for biosimilars.
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.
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