Joint Clinical Assessments: Harmonizing Medicine Evaluations Across Europe Under EMA Regulations

A Joint Clinical Assessment (JCA) refers to a coordinated evaluation of the clinical evidence of a medicine's efficacy, safety, and therapeutic value, conducted by multiple health technology assessment (HTA) bodies across Europe. This process aims to streamline and harmonize the assessment procedures, ensuring that all participating countries have access to consistent and high-quality clinical evaluations.


After 12 January 2025, medicinal products falling under the scope of HTA Regulation (Regulation (EU) 2021/2282 Article 7) will be subject to a JCA. Initially, the JCA will be applicable for medicinal products with new active substances for cancer treatments and for advanced therapy medicinal products. From 13 January 2028, it will also be applicable to all medicinal products with an orphan drug designation and from 13 January 2030, all other medicinal products falling under the scope of Article 7 of Regulation 2021/2282 will also be subject to JCA.


A JCA following EMA regulations will bring several advantages:


1. Collaborative Process: The JCA is carried out collaboratively by HTA bodies from different EU member states. This collective effort is designed to reduce duplication of work and promote shared expertise and resources.


2. Centralized Coordination: EMA and the European Network for Health Technology Assessment (EUnetHTA) often play central roles in coordinating JCAs. They provide frameworks, guidelines, and support to ensure that assessments are conducted in a standardized and efficient manner.


3. Comprehensive Evaluation: A JCA involves a thorough evaluation of clinical data, including results from clinical trials and other relevant studies. The assessment focuses on key aspects such as the medicine's efficacy, safety profile, and therapeutic benefit compared to existing treatments.


4. Transparency and Consistency: One of the primary objectives of JCA is to ensure that the clinical assessments are transparent and consistent across participating countries. This helps in providing uniform information to healthcare providers, payers, and patients.


5. Facilitating Market Access: By providing a single, harmonized clinical assessment, JCAs can facilitate faster and more streamlined market access for new medicines across Europe. This is particularly important for innovative therapies that can significantly impact public health.


6. Regulatory Framework: The implementation of JCAs is governed by specific regulatory frameworks and guidelines established by the EMA and relevant European bodies. These regulations ensure that the assessments are conducted rigorously and in accordance with the highest standards of scientific and clinical practice.


Overall, JCAs under EMA regulations aim to enhance the efficiency and effectiveness of clinical assessments, promoting the timely availability of important medicines to patients across Europe.




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