Real‐world evidence (RWE) has an increasing role in both pre-, and post- approval applications to support the authorization of new medicines and indications, or to address post-marketing safety concerns. Therefore, the use of Real-World Data (RWD) in regulatory processes at the European Medicines Agency (EMA) varies depending on whether it is being used for… Continue reading RWD for EMA Regulatory Submissions: Differences in Use for Pre- vs. Post-Approval
Category: Regulatory
Process for Health Technology Assessments (HTAs) in France
Health Technology Assessments (HTAs) in France are a key component of the healthcare system, used to evaluate the clinical efficacy, safety, and cost-effectiveness of new medical technologies, including drugs, devices, and procedures. The HTA process in France is highly structured and involves several key organizations, each with distinct roles and responsibilities. 1. High… Continue reading Process for Health Technology Assessments (HTAs) in France
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.… Continue reading Joint Clinical Assessments: Harmonizing Medicine Evaluations Across Europe Under EMA Regulations
Process for Health Technology Assessments (HTAs) in Germany
Health Technology Assessments (HTAs) in Germany are essential to evaluating the benefits, risks, and economic implications of medical technologies and interventions. The process involves several key institutions. These bodies have distinct roles in evaluating and deciding on the inclusion and reimbursement of health technologies within the healthcare system. Before looking at the process, let’s explore… Continue reading Process for Health Technology Assessments (HTAs) in Germany
Misleading Notions of "Regulatory-Grade" Data in Real-World Evidence Research
The concept of “regulatory-grade” data it has been used to describe data that meets the requirements necessary for regulatory decision-making in real world evidence (RWE) research. This term suggests that the data is of high quality, reliability, and integrity, suitable for supporting regulatory submissions and decisions regarding the safety, efficacy, and quality of medical products.… Continue reading Misleading Notions of "Regulatory-Grade" Data in Real-World Evidence Research