WHO Consults On New Framework To Evaluate And List Regulatory Authorities

The new framework, when finalized, will replace the widely-recognized concept of "stringent regulatory authorities." 

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WHO Has Proposed New Framework For Public Listing Of Regulatory Authorities • Source: Shutterstock

The World Health Organization is inviting stakeholder feedback on its proposal to develop a framework for evaluating and publicly designating regulatory authorities as WHO-listed authorities (WLAs).

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Global Pharma Guidance Tracker March 2025

 

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 Benefits As EU CTIS Hits Global Data Sharing Milestone

 

The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.

Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 

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Global Pilot Reduces Drug Manufacturing Inspections With Hybrid Approach

 
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A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.

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New Measures Can Cut Israel’s Drug Approval Time To Just 70 Days

 

Israel has introduced a new framework to expedite the marketing approval of medicines, make the country a more attractive destination for drug registration and help reduce drug prices through market competition.

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Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
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US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth