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Global Pharma Guidance Tracker – February 2024
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.
Quality Officers Call For New Approaches To Reduce Global Manufacturing Change Complexity
Pharmaceutical quality leadership proposes eight-step “dance” with complex global regulatory system for allowing manufacturing processes to improve more quickly. The data showed many authorities take more than the recommended six months to decide on post-approval changes, with assessments taking almost eight years in some cases.
Disputes Over Access & Benefit Sharing Dog Pandemic Treaty Talks
As talks restart this week on a future pandemic accord, the international drug industry body, the IFPMA, has reiterated its concerns over the negotiating text, saying some measures could “severely hinder responses to future pandemics.”
From COVID Cliff To GLP-1 Ramp: Novo Takes Catalent Plants For Next Public Health Crisis
A complex transformation is underway as client proposes to acquire CDMO facilities that vaccinated the world against the COVID-19 pandemic for pivot to the obesity epidemic.
WHO Tightens Up Guidance On Reserving Most Critical Antimicrobials For Humans Only
All new classes of antimicrobials for human use will fall within the World Health Organization’s highest criticality category under its latest guidance on preventing antimicrobial resistance.
Global Pharma Guidance Tracker – January 2024
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.
WHO Outlines Priority Actions For Tackling AMR In 2024
An updated priority pathogen list, a review of the clinical pipeline for antibacterials, and high-level meetings with other global regulators are among the steps that will be taken by the World Health Organization in the year ahead to combat antimicrobial resistance.
WHO Announces ‘More Attractive’ Successor To COVID-19 Technology Access Pool
The WHO sees the HTAP as an important step in securing more equitable access to a wide range of health products by sharing intellectual property and scientific knowledge. But the pharmaceutical industry wants to see more detail and has warned against a global “one-size-fits-all approach” to the licensing of medicines and vaccines.
Regulatory Reliance Pathways: Challenges And Opportunities Ahead
International interest in fast-track regulatory reliance and collaboration pathways such as Project Orbis and the ACCESS Consortium has grown in recent years, a trend that looks set to continue in 2024. But some policy experts have warned that faster approvals are not always better, with one academic claiming the bar for marketing authorizations has dropped “far too low.”
WHO Releases Ethics Guidance On Generative AI Use In Health Settings
New guidance from the World Health Organization sets out ethical recommendations around the use of large multi-modal models, a type of AI sometimes used by pharmaceutical companies during drug discovery and development.
WHO Proposes Guidance To Curb Antibiotic-Containing Discharges From Production Sites
The World Health Organization says that all actors, including the pharmaceutical industry, waste management companies, regulators and reimbursement agencies, have a part to play in dealing with manufacturing waste containing antibiotics.
Global Pharma Guidance Tracker – December 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.
Safety Limits On AI Could Emerge From US And International Initiatives
Guardrails protecting the public from artificial intelligence and machine learning systems are under development in the US and internationally. Whether they will inhibit global pharmaceutical manufacturers remains an open question that is sure to be discussed in the months and years ahead.
WHO Reflects On ‘Plethora Of Learnings’ From COVAX As Initiative Ends
COVAX, a global initiative that was established to provide equitable access to COVID-19 vaccines worldwide, will end on 31 December, freeing up funds for new inoculation equity schemes across the globe.
How The ACCESS Consortium’s New ‘Promise Pathway’ Can Benefit Drugmakers
Pharmaceutical companies that develop new medicines for life-threatening or severely debilitating conditions could be eligible to file for a priority review in the five ACCESS Consortium member countries under a new pilot scheme.
ICMRA Chief On The Future Of Regulatory Collaboration & The Move Towards Convergence
Artificial intelligence, real world evidence and point of care manufacturing are top priorities for the International Coalition of Medicines Regulatory Authorities, says the coalition’s chair, Emer Cooke.
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