International

Global Regulators Explore The Opportunities & Challenges Involved With Platform Trials

 
• By 

The International Coalition of Medicines Regulatory Authorities wants to see the rapid establishment and efficient conduct of platform clinical trials during public health emergencies.

Quotable: Top Experts On Policy Hot Topics

 

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Plan For Global CMC Assessment Platform Advances To Next Phase

 
• By 

The International Council for Harmonisation is seeking input from IT vendors on what it will take to establish a state-of-the-art technology platform that drug sponsors can use to submit quality-related post authorization submissions for collaborative assessment by multiple regulatory authorities.

ICH Embraces Innovation In Clinical Trial Design

 
• By 

The International Council for Harmonisation has issued for comment draft guidance, which when finalized, is expected to provide the industry with flexibility to embrace non-traditional, innovative approaches in clinical trial design.


AstraZeneca: AI Regulations ‘Tricky’ To Interpret & Navigate

 

The pharma industry wants regulators around the world to engage with companies and “articulate the value added” when introducing new regulations and guidance around the use of AI in drug development, AstraZeneca’s director for data and AI policy says.

US FDA Heading In ‘The Same Direction’ As EMA On AI In Drug Development

 

Global regulators should work together on producing standard terminology around the use of AI in drug development to align as much as possible on their approaches, according to the Food and Drug Administration’s Tala Fakhouri.

Global Pharma Guidance Tracker – October 2024

 
• By 

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.

ICH Q5A(R2): ‘More Regulatory Flexibilities Than Hurdles’

 
• By 

CRO executive Horst Ruppach discusses the critical factors that drug manufacturers must consider to ensure compliance with the revised ICH Q5A(R2) guideline on biologics viral safety. Thorough documentation and proactive engagement with regulatory bodies are key to navigating the complexities of viral safety evaluation in biotechnology products, he says.


Astellas Praises EU & US Regulators For Collaboration In Gene Therapy Space

 

The move towards greater regulatory collaboration is a positive step for gene therapy developers, Astellas’ gene therapy strategy lead Richard Wilson says – adding, however, that pharma still needed to understand the Asian markets better.

Quotable: Top Experts On Policy Hot Topics

 

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Clearer Regulatory Frameworks Needed For Ultra-Rare Conditions, Experts Say

 

Meeting the regulatory gold standard for drug candidates in ultra-rare diseases can be impractical, a regulatory expert says, but greater collaboration and shared insights from regulatory reviews could help find a viable path forward.

Decentralized Manufacturing Sponsors Must ‘Do Their Homework’ To Impress US & EU Regulators

 

Decentralized manufacturing methods for cell and gene therapies will be critical for improving patient access to treatments, but sponsors must prepare to demonstrate “comparability” with centralized manufacturing.


ICH Guidelines: Regulatory Members & Observers Show Strong Compliance

 

An examination of the global implementation of guidelines from the International Council for Harmonisation by regulators has yielded positive outcomes.

Europe Must Turn To Science Diplomacy With Developing Countries To Counter Tomorrow’s Health Threats

 

Public-private partnerships can help industry better understand neglected diseases and develop potential treatments.

Could US-Style Priority Review Vouchers Drive European Neglected Disease R&D?

 

Having its own priority review vouchers could serve as an important pull incentive for neglected disease R&D in Europe, although the unpredictable nature of the vouchers may deter some investors.

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 

The US FDA Commissioner pushed for rebalancing the US’s pharmaceutical supply chains while also stressing that US-China commerce has a role that would be risky to compromise. 


EMA And FDA Eliminating ‘Needless Differences’ – Particularly For Rare Diseases

 

US and EU regulators have invited two companies to work with them on a pilot scheme for assessing drugs for rare genetic diseases, a move that the European Medicines Agency’s Emer Cooke said would help improve “global alignment.”

UK’s ISRCTN Registry Makes It Easier To Track Clinical Trial Transparency

 
• By 

The ISRCTN clinical trials registry has launched an improved dashboard to provide metrics that reveal how many studies are complying with key transparency requirements. Badges are in place for individual studies meeting the transparency criteria.

WHO Homes In On Best Practices For More Effective And Equitable Clinical Trials

 
• By 

Patient centricity, diversity, innovation and transparency are key topics in the World Health Organization’s new guidance that recommends best practices for clinical trials and complements existing international guidance in this area.

Tech Vs Trialists: The Struggle For Integrated Decentralized Clinical Trial Platforms

 
• By 

The EU’s public-private Trials@Home Consortium examined what it would take to develop the fully integrated, unified digital platforms needed to enhance the implementation of decentralized clinical trials.