European Medicines Agency

The European Medicines Agency (EMA) is an agency of the European Union in charge of the evaluation and supervision of medicinal products. It is the European Union’s equivalent to the Food and Drug Administration (FDA) in the United States.¹⁾

Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency.

The European Medicines Agency is at the core of the European Union’s (EU's) medicine and health system, and aims to protect human and animal health. To ensure that the system works effectively, the Agency works closely with its partners and stakeholders, and is a proactive member of important networks in Europe and beyond. ²⁾

On this page, you will find information on the Agency’s activities that are most relevant to pharmaceutical industry, including news, and events. You can contribute to the Agency’s work by responding to public consultations. Learn more about how the pharmaceutical industry is actively involved in the work of the Agency. ³⁾

Innovation offices in national regulatory agencies have been working informally with the EMA's Innovation Task Force (ITF) on matters relating to emerging therapies and technologies since 2011. In 2015, EMA and the EU national competent authorities (NCAs) strengthened their collaboration to support medicine innovation and early development of new medicines in the EU by establishing the EU innovation network.

EMA and the HMAs adopted the mandate of the EU-Innovation Network in October 2016

2014 - The Innovative Medicines Initiative (IMI) WEB-RADR project aims to explore the use of mobile technologies and social media to further improve the collection and analysis of information on the suspected adverse drug reactions. This includes the use of mobile apps to report adverse reactions, the possibility identifying potential safety issues with medicines from user comments (posts) on social media as well as the safety information on medicines.

The workshop provided an opportunity to discuss expectations with different stakeholders such as members of the European Medicines Agency (EMA) Healthcare Professionals' Working Party, the Patients' and Consumers' Working Party, the Pharmacovigilance Risk Assessment Committee, representatives of young people from the Paediatric Committee, experts in pharmacovigilance, medical ethics and data protection as well as the IMI WEB-RADR Consortium. The report on the outcome of the workshop hosted by EMA is available on the IMI website. ⁴⁾

The aim of the network is to make the regulatory support for medicines developers currently available at national and EU levels more visible and attractive to innovators ⁵⁾

List of eligible industry stakeholder organisations (as of 16 May 2018) With reference to the Criteria to be fulfilled by industry stakeholder organisations involved in EMA activities, (EMA/323235/2016), the following organisations have been deemed eligible to be consulted and involved directly or to co-operate with the Agency in specific areas. All of the organisations in this list are also included in the EC Transparency Register, which provides further detailed information. ⁶⁾

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU.

Before a medicine is authorised for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are selected carefully and followed up very closely under controlled conditions. This means that at the time of a medicine's authorisation, it has been tested in a relatively small number of selected patients for a limited length of time.

After authorisation the medicine may be used in a large number of patients, for a long period of time and with other medicines. Certain side effects may emerge in such circumstances.

It is therefore essential that the safety of all medicines is monitored throughout their use in healthcare practice.

EU law therefore requires each marketing authorisation holder, national competent authority and EMA to operate a pharmacovigilance system. The overall EU pharmacovigilance system operates through cooperation between the EU Member States, EMA and the European Commission. In some Member States, regional centres are in place under the coordination of the national competent authority.

EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring the safety of human medicines. It is made up of experts in medicines safety from regulatory authorities in Member States, plus scientific experts and representatives of patients and healthcare professionals nominated by the European Commission.

EMA supports the PRAC by providing data from clinical practice available in electronic health records or prescription databases.

The Agency is responsible for developing and maintaining EudraVigilance, a system for managing and analysing information on suspected adverse reactions to medicines authorised in the European Economic Area (EEA).

EudraVigilance is a single repository for reports of suspected adverse reactions seen in healthcare practice and clinical trials. It is used by Member states, the Agency and industry.

The PRAC evaluates safety signals from EudraVigilance and may recommend regulatory action as a result. For more information, see Signal management.

EMA publishes data from EudraVigilance in the European database of suspected adverse drug reaction reports.

Users can view the total number of individual suspected side effect reports submitted to EudraVigilance for each centrally authorised medicine.

Reports for drug substances used in nationally authorised medicines are also available since October 2014.

The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for prioritising and assessing signals and issuing subsequent recommendations on medicines authorised in the European Union, including nationally and centrally authorised medicines.

The PRAC recommendation may include one or a combination of conclusions, including:

• No need for further evaluation or action at present;
• Need for additional information, including:
• monitoring any relevant emerging information as it becomes available,;
• additional analysis in EudraVigilance or other data sources;
• additional data from the marketing authorisation holder in the next periodic safety update report (PSUR) or submit an ad-hoc PSUR;
• a post-authorisation safety study conducted by the marketing authorisation holder;
• Need for regulatory action, such as:
• updating of the product information (summary of product characteristics and package leaflet) and/or risk management plan through a variation;
• a referral procedure;
• urgent safety restrictions. ⁷⁾

The MHRA has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in place for this product at all sites responsible for the manufacture, assembly and batch release of this product.

A Risk Management Plan (RMP) and a summary of the pharmacovigilance system have been provided with this application and are satisfactory.

This batch, and any future batches, of COVID-19 mRNA Vaccine BNT162b2 are subject to Qualified Person (QP) certification and batch evaluation by an independent control laboratory before the vaccine is released into the UK.

The COVID-19 Vaccine Benefit Risk Expert Working Group (Vaccine BR EWG) have met several times to review and discuss the quality, safety and efficacy aspects in relation to batches of COVID-19 mRNA Vaccine BNT162b2. The manufacturer, Pfizer/BioNTech, was also invited to a separate meeting with the quality subgroup of the Vaccine BR EWG to review and discuss questions related to manufacture and control of the product.

The Vaccine BR EWG gave advice to the Commission of Human Medicines (CHM) on 11th September 2020, 8th October 2020, 27th October 2020, 28th November 2020 and 30th November 2020, regarding the requirements for authorisation for the temporary supply of COVID-19 mRNA Vaccine BNT162b2. The requirements for quality, safety and efficacy were considered, taking into account the urgent public health need and risk to life, the pandemic situation and a lack of COVID-19 vaccines. As well as data on quality, safety and efficacy, specific mitigations and conditions on the product were discussed to ensure adequate standards of quality and safety are met.

The CHM concluded that the proposed supply of COVID-19 mRNA Vaccine BNT162b2 for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older, is recommended to be suitable for approval under Regulation 174 provided the company meets the conditions set out by the MHRA.

Authorisation for the temporary supply of COVID-19 mRNA Vaccine BNT162b2 was granted in the UK on 1 December 2020. This report covers data received and reviewed for this authorisation only. This authorisation is valid until expressly withdrawn by MHRA or upon issue of a marketing authorisation.

On 4 June 2021 the MHRA granted an extension of indication to ‘the active immunisation to prevent COVID-19 caused by the SARS-CoV-2 virus, in individuals 12 years of age and older’. ⁸⁾

EMA’s COVID-19 Steering Group provides strategic oversight at EMA of the evolving scientific and regulatory challenges created by COVID-19, and other topics and emerging issues of importance, including from a political, interinstitutional or international perspective. ⁹⁾

• COVID Truth Initiative

• https://web.archive.org/web/20181002223839/https://www.ema.europa.eu/documents/scientific-guideline/guideline-strategies-identify-mitigate-risks-first-human-early-clinical-trials-investigational_en.pdf