What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

The EMA'S approach to non-traditional studies should be echoed in the joint clinical assessment process. (Shutterstock)
Key Takeaways
  • The joint clinical assessment process, now under way for two products, could be improved by applying the European Medicines Agency’s approach to non-traditional clinical research.

Taking lessons from the European Medicines Agency on dealing with unconventional development pathways will help improve the new joint clinical...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Advanced Technologies

New US FDA Biologics License Pathway Could Be Missing Link To Reduce Animal Testing

 

Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.

Capricor Gets Complete Response For DMD Cell Therapy: Unconvincing Data Or New Attitude At FDA?

 
• By 

Seven weeks before its action date and a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
• By 

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

More from R&D

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By 

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.

Korea Pre-Review Consultations Help Accelerate R&D

 
• By 

A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.