Transparency is an important feature of the European Medicines Agency's operations. As for any public authority, the Agency strives towards being as open as possible about how it works and how it comes to its decisions.
Since its formation in 1995, the Agency has published detailed information on its scientific assessment work, through the European public assessment report (EPAR), a unique tool among medicines regulators in describing the basis for opinions on how medicines should be used. Over the subsequent years, the Agency has worked towards increasing the level of openness over how it works, through publication of information on its scientific and non-scientific operations and a continuous effort to explain its decisions and procedures.
European Union (EU) law sets the minimum level of transparency that the Agency must apply. However, in many areas, the Agency has decided to go beyond what law requires, so that it can provide as much information to the public as possible, as for example, the publication of clinical data submitted by industry to support their marketing applications for human medicines under the centralised procedure. In all cases, it takes care to balance this with the protection of commercially confidential information and personal data.
This page summarises the types of information that the Agency releases proactively on its activities. In addition, the public has the right to request information and documents from the Agency in accordance with its rules on access to documents and on access to information.
The medicine authorisation process
The Agency releases information on the medicines it is evaluating at various stages during the marketing-authorisation process.
The Agency publishes a list of the international non-proprietary names (INNs) and therapeutic areas for all human medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP). It publishes an updated list every month. The Agency also publishes the agendas and minutes of its scientific committee meetings, which contain information on the medicines discussed at each meeting.
At the end of the evaluation process by the CHMP or the Committee for Medicinal Products for Veterinary Use (CVMP), the Agency publishes a summary of the committee's opinion. This explains the reasons for the committee's opinion, as well as details of the company applying for a marketing authorisation.
|Authorisation or refusal|
Once the European Commission has issued a decision on the marketing authorisation for a medicine, the Agency publishes a European public assessment report. This includes a summary for the public, the assessment report from the CHMP or CVMP and the approved product information, including the summary of product characteristics, labelling for the medicine's outer packaging and the text for the package leaflet. The public summary and product information are published in in all official European Union (EU) languages. When a new marketing-authorisation application is refused, the Agency publishes a refusal European public assessment report, including a question-and-answer document and an assessment report.
The Agency continues to update the EPAR for each medicine while it is on the market, including information on the approved changes to the marketing authorisation. This includes publication of press releases and question-and-answer documents summarising the major changes recommended by the Agency's committees and committee assessment reports when the change is approved by the European Commission.
If an application to change the marketing authorisation is refused, the Agency may also publish documents such as an assessment report as part of the EPAR.
The Agency also publishes information on ongoing applications for extensions of the indication for authorised human medicines in the minutes of the Pharmacovigilance Risk Assessment Committee (PRAC). These include applications where a change to the medicine's risk-management plan is needed.
At any stage during the evaluation, the applicant can withdraw its application. In some cases, the Agency will publish documents such as a question-and-answer document, withdrawal letter and assessment report in the form of a withdrawal EPAR:
Publication of clinical data submitted by industry to support their marketing applications
As of October 2016, the Agency publishes the clinical data submitted by pharmaceutical companies to support their marketing applications for human medicines under the centralised procedure. This is a result of the implementation of its policy on the publication of clinical data.
To access these data, users need to visit the clinical data publication website and login with an EMA account. They can choose between an on-screen view only or a full download-and-print access. Terms and conditions apply.
Meetings and workshops
The Agency publishes the agendas and minutes of its scientific committee meetings, in line with principles set out in the below document:
The outcomes of each scientific committee meeting are also summarised in highlights published shortly after the meeting and/or in more detailed monthly reports, depending on the committee.
For the Management Board, the Agency publishes the agendas and non-confidential outcomes of each meeting.
The events and meeting calendar also shows the events and workshops that the Agency organises. These include workshops on the authorisation and surveillance of medicines, some of which are open to the public. Following most events, the Agency publishes a meeting report and the presentations given at the meeting. Video recordings of the most popular meetings are available on the the Agency's YouTube channel.
The Agency publishes other outcomes related to medicines:
Maximum residue limits are the maximum concentration of residue accepted in a food product obtained from an animal that has received a veterinary medicine. These are determined by the CVMP:
- Maximum residue limit opinions (pending European Commission approval)
- Maximum residue limit reports (following European Commission approval)
Orphan designations are designations that permit a pharmaceutical company to benefit from incentives from the European Union (EU) to stimulate development of a medicine for a rare disease. These are granted on the recommendation of the Committee for Orphan Medicinal Products (COMP):
Paediatric investigation plans are plans determined by the Paediatric Committee setting out how a medicine should be studied in children in order to support its authorisation in children:
The Agency publishes information on the assessment of scientific information on herbal medicines carried out by the Committee on Herbal Medicinal Products (HMPC):
Conflicts of interests of staff and experts
The Agency takes care to ensure that its scientific experts, staff and Management Board do not have any financial or other interests in the pharmaceutical industry that could affect their impartiality.
It publishes information on the interests of its management staff, experts and Management Board members online. For more information, see handling conflicts of interests.
|Management staff||Experts and committee members||Management Board members|
|Curriculum vitae (CV)||Published||Published||Published|
|Declaration of interests (DoI)||Published||Published||Published|
|Risk level||Published within DoI||Published||Published within DoI|
Side effects of medicines
Information on suspected side effect reports are available in the European database of suspected adverse drug reaction reports.
This website allows users to view the total number of individual suspected side effect reports submitted to the EudraVigilance database for each centrally authorised medicine. They can sort these reports by age group, sex, type of suspected side effect and outcome.
Reports for common drug substances used in nationally authorised medicines will be published during 2014.
Information on clinical trials is available in a public register called EU Clinical Trials Register.
This gives access to information on interventional clinical trials for medicines authorised in the EU, as well as Iceland, Liechtenstein and Norway, and trials authorised to be carried out outside the EU as part of a paediatric investigation plan.
The Agency also maintains a public database of studies conducted in children that were completed by the date of entry into force of the Paediatric Regulation on 26 January 2007: Article 45 paediatric studies database.
Information on inspections of the manufacturing sites for medicines performed by regulatory authorities in the EU, Iceland, Liechtenstein and Norway are available in a public database called EudraGMP.
Related guidance from the Heads of Medicines Agencies (HMA) and EMA
- HMA/EMA guidance document on the identification of commercially confidential information and personal data within the structure of the marketing-authorisation application: Release of information after the granting of a marketing authorisation
- HMA/EMA recommendations on transparency: Recommendations on the handling of requests for access to periodic safety update reports
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- Letter to European Ombudsman (2015-02-10)
- European Medicines Agency policy on publication of clinical data for medicinal products for human use (2014-10-02)
- Principles for publication of agendas and minutes of EMA scientific committees (2013-12-18)
- Procedural advice on publication of information on negative opinions and refusals of marketing authorisation applications for human medicinal products (2013-05-06)
- Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products (2013-06-27)