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...

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...

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...

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...

This paper provides an overview of the role of the United States of America (U.S.) Second World War research effort on the direction of innovation, with a particular focus on medical research. It provides an overview of the U.S. wartime research program, reviews quantitative evidence on the...

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...

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.

Financial ties between drug companies and medical researchers are thought to bias studies published in medical journals. To enable readers to account for such bias, most medical journals require authors to disclose potential conflicts of interest. We examine whether disclosure reduces article...

Women physicians continue to achieve tremendous advancements in medicine, both professionally and personally, from the boardroom to the front lines of the COVID-19 response. Women continue to be on an uneven playing field with their male coworkers because of persistent and serious inequities....

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...

Medicines, vaccines, medical devices, and blood are commonly used to treat disease. Medicines deserve a special focus because almost any medical visit ends with at least one prescription. So, monitoring the safety and effectiveness of therapeutic treatments and procedures is crucial at both the...

During World War II, the U.S. Committee on Medical Research (CMR) undertook an integrated, cross-sectoral effort to develop medical science and technology for war, representing the U.S. government's first substantial investment in medical research. Using data on all CMR research contracts, we...

Innovations and challenges in space medicine and healthcare explores space medicine's history, relevance, and impact on global health and sustainable development. It explores the effects of space travel on the human body, medical technologies and research, spacecraft and habitat design, and case...

Scholars and policymakers across the ideological spectrum agree that the U.S. drug pricing system is deeply flawed. Most reform proposals focus on one symptom: high prices for existing drugs. But high prices aren’t all that ails the U.S. drug pricing system: Current law also provides weak...

Financial ties between drug companies and medical researchers are thought to bias results published in medical journals. To enable readers to account for such bias, most medical journals require authors to disclose potential conflicts of interest. For such policies to be effective, conflict...

This paper sets up a quasi-experiment to estimate the impact of medical innovations on the economic outcomes for the individual and their family based on the rich administrative data for Sweden covering 1 million persons. I find that an increase in medical innovations by one standard deviation...

This report presents an overview of available and emerging non-animal models in the field of cardiovascular disease (CVD) research. Over 14,000 abstracts published between 2013 and 2019 were scanned for relevant non-animal methods for CVD. From these, 449 publications were identified as...

This report presents an overview of available and emerging non-animal models in the field of cardiovascular disease (CVD) research. Over 14,000 abstracts published between 2013 and 2019 were scanned for relevant non-animal methods for CVD. From these, 449 publications were identified as...

Advanced therapy medicinal products (ATMPs) are a fast-growing class of innovative biological products. They include somatic cell therapy, gene therapy, tissue-engineering and their combinations, and they hold the key for new treatments for rare diseases and the establishment of personalised...

This report updates the 2006 analysis in line with the present requirements of BIS.Techniques used in patent landscaping have also evolved since the first report so the analysis in this project is specifically based around the country of residence of patent applicants.This gives a better...

Newly independent countries always expressed the need for an equal access to essential medicines based on international human rights treaties. The right to access essential medicines was officially expressed in 2001 during the World Trade Organization’s (hereinafter “WTO”) Doha Conference....

This thesis investigates the relationship between health data pools and innovation in biomedical research. Health data pool is a unique way of collecting data from numerous sources into a centralized administrator to analyze the data and provide valuable insights to the contributors. The...

This paper investigates the local impact of biomedical research on mortality in the USA. Causally estimating the marginal value of biomedical research is challenging due to a lack of micro data linking health outcomes to plausibly exogenous variation in research. We create a new linkage between...

Most aging countries in the world are experiencing the problems of insufficient motivation for technological innovation and excessive medical costs. This research thus utilizes medical patent applications and medical innovation efficiency to measure medical innovation for 41 countries covering...