Welcome to the 2024 EMA annual report, which highlights milestones and achievements of the past year, and our regulatory network's commitment to bringing value to public and animal health in the European Union (EU).

Welcome to the 2024 EMA annual report, which highlights milestones and achievements of the past year, and our regulatory network's commitment to bringing value to public and animal health in the European Union (EU).

Finding effective treatment for patients with rare diseases can be very difficult. Since the EU orphan regulations entered into force in 2000, it has played a central role in facilitating the development and authorisation of medicines for rare diseases.

In 2024, EMA recommended 114 medicines for marketing authorisation. Of these, 46 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address public health needs or the...

In 2024, EMA recommended 114 medicines for marketing authorisation. Of these, 46 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address public health needs or the...

In the last quarter of 2020, the European medicines agencies network - comprising national competent authorities (NCAs) and the European Medicines Agency (EMA) - published its five-year strategy covering the period from 2021 to 2025. The strategy (EMANS 2025) has now undergone an update to cover...

In the last quarter of 2020, the European medicines agencies network - comprising national competent authorities (NCAs) and the European Medicines Agency (EMA) - published its five-year strategy covering the period from 2021 to 2025. The strategy (EMANS 2025) has now undergone an update to cover...

Welcome to the 2024 EMA annual report, which highlights milestones and achievements of the past year, and our regulatory network's commitment to bringing value to public and animal health in the European Union (EU).

Sustainable Medicine Consumption (SMC) encompasses responsible consumer practices related to the acquisition, use, and disposal of medicines while considering social, economic, and environmental sustainability dimensions. This study employs the Delphi method to achieve expert consensus on key...

This Critical Medicines Alliance is a new consultative mechanism bringing together national authorities, industry, civil society, the Commission and EU agencies to identify the best measures to address and avoid shortages of critical medicines. It complements regulatory measures in the proposed...

This paper analyzes the debate over the international dissemination of data exclusivity as a form of protection for clinical trial data. This is a critical demand for pharmaceutical companies seeking larger market shares and longer periods of monopoly in order to recover investments in research...

The European Union stepped up its action in the area of health - a shared competence between the EU and its Member States - in response to the COVID-19 pandemic. Yet, the EU lacks a joint health policy that recognises health as a public good. This study investigates three areas where there is...

The objective of this research is to learn about the status of patent applications for monoclonal antibodies (mAbs). The paper analyzes the different claim strategies used by applicants to obtain patent protection. The database constructed and described in South Centre Research Paper No. 186 was...

There is a conspicuous void of analyses about the economic and policy analysis of heart disease research funding in the United States and in other countries. This book discusses the economic and policy dimensions of heart disease research—the leading cause of death in the United States and...

Introduction to physical medicine and rehabilitation and the supporting fields -- Global and historical context -- PM&R and inpatient setting -- PM&R and outpatient settings -- PM&R and educational settings -- PM&R and wellness setting -- Research on the design of rehabilitation environments --...

Capitalizing a Cure takes readers into the struggle over a medical breakthrough to investigate the power of finance over business, biomedicine, and public health. When curative treatments for hepatitis C launched in 2013, sticker shock over their prices intensified the global debate over access...

Welcome to EMA's annual report for 2022. In here you will find details about EMA's achievements and milestones during another transformative year for the Agency, the regulatory network and European healthcare systems as a whole.

This paper explores the economic incentives for medical procedure innovation. Using a proprietary dataset on billing code applications for emerging medical procedures, we highlight two mechanisms that could hinder innovation. First, the administrative hurdle of securing permanent, reimbursable...

The U.S. has two systems of funding research at universities—a public one of Congressional appropriations and a private “submerged state” involving nonprofit funders subsidized by taxpayers. Here we examine the case of biomedical research and demonstrate that the “submerged state” can...

Capitalizing a Cure takes us into the struggle over accessing a medical breakthrough to investigate the power of finance over business, biomedicine, and public health. When sofosbuvir-based medicines launched in 2013, they promised a cure for millions of patients worldwide with hepatitis C. But...