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Spain Consults On Plans To Regulate HTAs

 
• By Francesca Bruce

New rules on health technology assessments in Spain make room for real-world evidence and early dialogue.

Spain
New Spanish HTA system would align with EU HTA reg • Source: Shutterstock

The Spanish health ministry is asking for feedback on a draft royal decree that would for the first time regulate health technology assessments (HTAs) for health care products in Spain. It would also align the system with the EU HTA Regulation 2021/2282, which introduced EU-level joint clinical assessments.

Key Takeaways

  • Spain is consulting on plans to regulate its HTA system for medicines, medical devices and other technologies for the first time.

  • The draft decree would prepare Spain for the EU HTA Regulation that introduced EU-level joint clinical assessments

The

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