UK’s MHRA To Offer Private Meetings For Innovative RWE Strategies

The MHRA’s new scientific dialog program will offer drug developers “closed-door meetings” that will offer “confidential, commercially sensitive discussion” with its staff to help them “refine” their real-world evidence generation strategies.

A new real-world evidence (RWE) program, set to be launched by the UK’s Medicines and Healthcare products Regulatory Agency, will see innovative drug developers benefit from private meetings with representatives from the agency and England’s health technology assessment (HTA) body, NICE.

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German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

 

Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.

Canada’s New Rare Disease Registry Guidance To Assist Regulatory And HTA Decision Making

 

Canada’s new guidance on rare disease registries is based on international guidelines, but in some areas there remains work to ensure that implementation of some recommendations is feasible in the Canadian context.

Ad/Promo: Improved Adherence Claim For Dexcel’s Hemady Not Supported, US FDA Says

 
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A retrospective analysis does not support a claim that multiple myeloma patients are more adherent to Hemady than generic dexamethasone, OPDP said in an "untitled" letter suggesting increased enforcement focus on promotions leveraging the agency’s 2018 CFL guidance.

What India’s Digital Personal Data Protection Norms May Mean For Clinical Trials, Big Pharma GCCs

 

Legal heavyweights from Nishith Desai Associates, Anand and Anand, Corporate Law Group and EY partner and national cyber leader talk about compliance requirements that pharma and global capability centers may need to consider as India strengthens the framework for the protection of digital personal data.

More from United Kingdom

German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

 

Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.

EU Clinical Trials Regulation Failing To Harmonize Requirements, But UK Has ‘Great Opportunity’

 

The Clinical Trials Regulation was “supposed to harmonize” requirements in the EU, but instead it is giving some countries the chance to get ahead by offering faster approval timelines, notes Telethon’s head of regulatory affairs.

Industry Slams UK Plan To ‘Demand A Third’ Of Drug Company Revenue In Q2/Q3 2025

 

The government wants to raise the statutory scheme payment rate for newer branded medicines from 15.5% to 32.2%, after sales data for Q2 and Q3 2024 showed “higher than expected newer medicines sales growth.”