Compounding pharmacies that set their own safety and accreditation standards now stand the best chance of keeping patient access intact before heavier regulation does it for them.
Feature|Articles|October 7, 2026
Countdown to JCA: What APAC and US Drug Developers Need to Know and do Today
Author(s)Mia Malmenas
What North American and APAC sponsors need to know about EU Joint Clinical Assessment — and why EMA approval doesn't guarantee reimbursement.
Advertisement
Advertisement
Sponsors in North America and APAC with plans to enter the European marketplace must contend with Joint Clinical Assessment (JCA) rules. These EU Health Technology Assessment Regulation (HTAR) requirements were first applied to new oncology medicinal products and advanced therapy medicinal products (ATMPs) in January 2025. The EU Member State Coordination Group on HTA (HTACG) began introducing JCAs for selected high-risk medical devices from June 2026. Orphan medicinal products will fall under JCA rules in January 2028 and by 2030 all remaining medicines must comply. Many North American and APAC sponsors and health technology developers (HTDs) are under prepared to meet the different expectations. Dossier preparation should begin at least 20 months in advance of submission and January 2028 is just over a year away. For sponsors embarking on phase 2 studies, now is the time to start preparations. Failure to do so can result in being unable to market drugs in the EU and the other countries that are party to the JCA process.
Related to this article
CORXEL’s chief medical value discusses how GLP-1s are becoming a chronic disease platform.
As Japan prices take on greater global significance, disciplined launch strategy can help pharma companies capture the full value of innovation.
Trialbee CEO Matt Walz explores the current impact of AI in delivering practical gains in clinical development and reflects on its future potential, where enrollment predictability may be the biggest prize of all.
Why effective RWD linkage starts with a specific research objective — and how tokenization, clean rooms, and AI make it possible.
FDA Approves Expanded Indication for Camzyos for Symptomatic Obstructive Hypertrophic Cardiomyopathy
FDA has expanded Camzyos's approval to treat symptomatic obstructive hypertrophic cardiomyopathy in pediatric patients as young as 12.
Digital health's point-solution era is giving way to broader platforms, and the cost-savings claims those platforms make to employers often don't hold up to methodological scrutiny.
MRD Testing Is Becoming the Most Important Tool in Oncology Drug Development: Q&A with Eric Matthews
MRD testing is transforming oncology trials — compressing timelines, enriching populations, and generating earlier answers.
Advertisement
Advertisement