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Don’t Reveal Patients’ Safety Data Just Because They Have, Trial Sponsors Told
A transparency consultant says companies should not be pressured into revealing sensitive safety data under clinical trial transparency initiatives even if this information is made available by trial participants themselves on social media sites.
Canada Consults On Policy Changes For Registering Clinical Trials & Disclosing Results
Health Canada is taking steps to improve transparency on authorized clinical trials and is creating a new trials search portal.
Brazil To Use Regulatory Reliance For GMP Inspections
Brazil’s medicines regulator Anvisa is considering new rules that would define regulatory reliance procedures for inspections and good manufacturing practice certification.
Global Pharma Guidance Tracker – February 2023
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.
Removing Confidential Data In Clinical Trial Reports Is ‘Like Stepping On Lego’
An expert in transparency explained what drug sponsors can do to support their compliance staff in identifying commercially confidential information in accordance with the clinical trial transparency initiatives of Health Canada and the European Medicines Agency.
Global Pharma Guidance Tracker – January 2023
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.
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.
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