Health technology developers will for the next four weeks have a chance to influence the rules governing the joint scientific consultations (JSCs) that will help them prepare for EU-level joint clinical assessments, which go live from January.
EU HTA Regulation: Views Wanted On Draft Rules On Joint Scientific Consultations
A newly published draft implementing act sets out the procedural rules for the joint scientific consultations that are foreseen by the EU’s Health Technology Assessment Regulation.

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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
More from Middle East & Africa
The World Health Organization has also prequalified the Bavarian Nordic vaccine to enable broader and timely access.
Companies marketing pharmaceutical products in Saudi Arabia are being urged to prepare for upcoming mandatory pharmacoeconomic assessments to demonstrate the added value of their drugs over existing treatments.
The Democratic Republic of Congo, the country worst hit by the mpox crisis, has now received the first batch of vaccines for the disease. Meanwhile, the World Health Organization is expected to complete its review for emergency use listing of mpox vaccines soon.