Advanced Therapy Developers Urged To Monitor Major EU Proposal On Using Blood, Tissues & Cells

Companies have the opportunity to tell the European Commission what they think about its proposed regulation that would overhaul the rules governing the use of substances of human origin.

Blood, tissues or cells may be used as starting materials for ATMPs • Source: Alamy

Companies developing advanced therapies are being advised to monitor developments surrounding a proposed EU regulation that seeks to improve the rules governing the use of substances of human origin (SoHOs). The proposal has been largely welcomed by industry.

The regulation, proposed by the European Commission, aims to strengthen the existing but outdated rules on the safety and quality of SoHOs, such as the blood, tissues and cells that...

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 Europe

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By 

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

More from Geography

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By 

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.