EMA

About EMA

 

 

 

 

European Medicines Agency (EMA)

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU). It is responsible for the scientific evaluation, supervision and safety monitoring of medicines.

EMA protects public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality. EMA serves a community of around 450 million people living in the EU, and has been operating since 1995.

The European Medicines Agency (EMA) has seven scientific committees and a number of working parties and related groups which conduct the scientific work of the Agency.

The committee’s evaluations of marketing-authorisation applications submitted through the centralised procedure provide the basis for the authorisation of medicines in Europe.

The committees and working parties also contribute to the development of medicines and medicine regulation, by:

  • providing scientific advice to companies researching and developing new medicines;
  • preparing scientific guidelines and regulatory guidance to help pharmaceutical companies prepare marketing authorisation applications;
  • contributing to the harmonisation of regulatory requirements on the EU and internationally.

CHMP

 

Committee for Medicinal Products for Human Use (CHMP)

The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency’s (EMA) committee responsible for human medicines. It plays a vital role in the authorisation of medicines in the European Union. The committee meets once a month. EMA publishes agendas, minutes and highlights of its plenary meetings.

CHMP’s assessments are based on a comprehensive scientific evaluation of data. They determine whether the medicine meets the necessary quality, safety and efficacy requirements and that it has a positive risk-benefit balance. An internal peer-review system safeguards the accuracy and validity of the opinions of the committee.

 

Highlights CHMP

PRAC

 

Pharmacovigilance Risk Assessment Committee (PRAC)

The Pharmacovigilance Risk Assessment Committee (PRAC) is the European Medicines Agency’s (EMA) committee responsible for assessing and monitoring the safety of human medicines. The Committee meets once a month. EMA publishes the agendas, minutes and highlights of its plenary meetings.

PRAC is responsible for assessing all aspects of risk management of human medicines, including:

  • the detection, assessment, minimisation and communication of the risk of adverse reactions, while taking the therapeutic effect of the medicine into account;
  • design and evaluation of post-authorisation safety studies;
  • pharmacovigilance audit.

 

PRAC provides recommendations on questions on pharmacovigilance and risk management systems, including the monitoring of their effectiveness, to the:

 

PRAC was formally established in line with the pharmacovigilance legislation which came into effect in 2012 to help strengthen the safety monitoring of medicines across Europe.

 

Highlights PRAC

ENCePP

 

The European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP) is an initiative that brings together expertise and resources in pharmacoepidemiology and pharmacovigilance across Europe. ENCePP is coordinated by the European Medicines Agency.

ENCePP is coordinated by the European Medicines Agency (EMA), that works closely with the below stakeholders to achieve the network’s objectives, as set up in the ENCePP Work Plan:

  • ENCePP Partners: The totality of representatives from registered research centres and networks. They meet once yearly at the ENCePP Plenary meeting.
  • Steering Group (SG): The decision-making body safeguarding the ENCePP principles, defining the objectives of the network, and deciding on its operational tasks.
  • ENCePP Secretariat: It supports the operational and administrative work of the SG. The Secretariat is provided by the EMA.
  • Working Groups (WG): ENCePP WGs are of a temporary nature in line with the ENCePP Work Plan. ENCePP Partners can contribute to the work of the WGs on a voluntary basis.
  • Special Interest Groups (SIG): ENCePP SIGs are established within the ENCePP network on an ad hoc basis to address shared interest in particular topics.

ENCePP Guide on Methodological Standards in Pharmacoepidemiology

The Guide on Methodological Standards in Pharmacoepidemiology offers a single online resource for methodological guidance in pharmacoepidemiology. For each topic covered, direct links to internationally agreed recommendations, key points from important guidelines, published articles and textbooks are provided. Where relevant, gaps in existing guidance are addressed with what ENCePP considers good practice.

ENCePP Checklist for Study Protocols

 

Considering current guidelines and the state-of-the-art in the areas of pharmacoepidemiology and pharmacovigilance, the Checklist for Study Protocols aims to:

  • stimulate researchers to consider important epidemiological principles when designing a pharmacoepidemiological study and writing a study protocol;
  • promote transparency regarding methodologies used in pharmacoepidemiological studies;
  • increase awareness about developments in science and methodology in the field of pharmacoepidemiology.

The Checklist is intended to promote the quality of studies and not their uniformity and is aligned with scientific and regulatory developments relevant to pharmacoepidemiology.

GVP module VIII on post-authorisation safety studies (PASS)  recommends that the Checklist is included as an annex to study protocols.

Code of Conduct

 

The ENCePP Code of Conduct provides a set of rules and principles for pharmacoepidemiology and pharmacovigilance studies to promote
  • scientific independence and
  • transparency throughout the research process.

To this end, the Code permits a high level of public scrutiny, which will ultimately increase the confidence of the general public, researchers and regulators in the integrity and value of pharmacoepidemiology and pharmacovigilance research.

The Code also promotes the implementation of best practice standards in the relationship between investigators, study funders, and contract research organisations (CROs)/coordinating study entities, from protocol agreement to publication of results.

Regardless of whether they are fully compliant with the Code, all pharmacoepidemiology and pharmacovigilance studies should be registered in the HMA-EMA Catalogue of real-world studies, ideally before they start, and protocols and study results should be made public.

The provisions of the Code apply to research that is (fully or partially) financed from external sources, e.g. studies commissioned by pharmaceutical companies, research grants etc. where researchers, study funders and other involved parties agree to adhere to the Code. Self-funded studies should also adhere to the Code.

Adherence to the Code is mandatory for studies seeking the ENCePP Seal.

The Code is referenced in Module VIII of the good pharmacovigilance practices (GVP) on post-authorisation safety studies (PASS) (Rev1)  relating to authorised medicinal products, published by the European Medicines Agency (EMA).

ENCePP Seal

 

Upholding high standards throughout the research process of studies in pharmacoepidemiology and pharmacovigilance based on the principles of scientific independence, transparency and robust methodologies is at the core of the ENCePP initiative. The Code of Conduct specifically aims to avoid financial, commercial or institutional interests of the study funder and potential personal interests of researchers that could influence the study results in any particular direction. To recognise studies following these ENCePP core principles, the ENCePP Seal has been introduced.

Studies bearing the ENCePP Seal are performed taking into account the relevant methodological research standards described in the ENCePP Guide on Methodological Standards in Pharmacoepidemiology and conducted in line with the rules and requirements for independent and transparent research laid down in the ENCePP Code of Conduct and in established international guidelines such as the World Medical Association Declaration of Helsinki and the European Code of Conduct for Research Integrity.

 

 

 

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