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Designed primarily to meet regulatory requirements for therapies targeting large patient populations, the existing development model lacks the flexibility, analytical power and efficiency to address today’s development demands. It is essential to develop a regulatory strategy plan early in drug development to identify key challenges that may arise, and interact collaboratively with regulatory authorities. This will also enable you to ensure that plan aligns with the profile and commercialisation for drug development.

COVID-19 regulatory news stories

COVID-19 regulatory updates

Governments worldwide are swiftly intervening to create alliances with pharma, biotech, diagnostics and medical device manufactureres to address the COVID-19 threat. International regulatory agencies are considering accelerated approvals, including Emergency Use Authorisations.

To stay up to date with all COVID-19 related regulatory content, visit ICON's Coronavirus Observatory. This tool utilises powerful AI analysis and data visualisation for COVID-19 news and social media including regulatory updates.

Coronavirus Observatory
Seeking parallel consultation from regulators and HTAs in Europe

Seeking parallel consultation from regulators and HTAs in Europe

Understanding and meeting the evidence requirements of regulators and HTA bodies can be complex. Early engagement can help. Read the whitepaper for key factors to ensure that parallel consultation meetings are well prepared, productive and informative.

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Early planning: The key to success under MDR and IVDR

Early planning: The key to success under MDR and IVDR

The European Union’s new Medical Device Regulation (MDR) came into effect on 26 May, 2021, and In Vitro Diagnostic Device Regulation (IVDR) will come into effect one year later. These new directives will bring:

  • Elevated clinical requirements
  • Re-classified and up-classified devices
  • A changing role of notified bodies, leading to bottlenecks and delayed timelines.
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Regulatory Intelligence newsletter

Regulatory Intelligence newsletter

Stay current on country, regional and global regulatory changes with ICON’s monthly Regulatory Intelligence Newsletter. It will keep you up to date with global regulatory changes that could impact your product.

Our experts review, interpret and summarise the latest regulatory developments so that you can spend more time taking your product to market. 

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