ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance)

Who sets the standard for a study the regulator did not run?

In one sentence

ENCePP is the European Medicines Agency's network of research centres that sets the standards for non-interventional studies of medicines.

Launched in 2007, it brings together public institutions, networks and contract research organisations; joining is voluntary and pharmaceutical companies cannot be partners. Its three tools, the Code of Conduct, the Checklist for Study Protocols and the Methodological Guide, are what the European Medicines Agency (EMA) points to in its guidance on post-authorisation safety studies.

Where it sits

CoordinatorThe EMA, which also provides the Secretariat
DecidesA Steering Group of 20, six of them elected by the partners, on three-year terms
NetworkENCePP: research centres, pharmacovigilance centres, hospitals, data holders and contract research organisations, meeting once a year
ToolsThe Code of Conduct, the Checklist for Study Protocols, the Methodological GuideReferenced in the EMA’s guidance on post-authorisation safety studies

Think of it like this

Think of the university labs of a country agreeing on how an experiment is written up, who may pay for it and where the results are posted. The ministry still orders the tests it needs, but asks that the labs’ rules be followed.

Key insights

A network, run from the EMAResearchers, not companiesThree tools and a registerWhat it is not

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is coordinated by the EMA, which provides its Secretariat. The partners meet once a year at a Plenary; a Steering Group of 20, established in 2010 and the network’s highest authority, sets the objectives and decides the work; temporary working groups deliver the work plan.

Partners are public and not-for-profit bodies in the European Union or the European Economic Area: research centres, pharmacovigilance centres, university hospitals, owners of healthcare data. Contract research organisations may join if they run studies commissioned by others. Pharmaceutical companies cannot be partners, though they are encouraged to use the tools. Joining is a box ticked when an institution registers in the HMA-EMA Catalogues.

The Code of Conduct, launched in 2010, sets rules for scientific independence and transparency between investigators, funders and contract organisations, from protocol to publication. The Checklist for Study Protocols makes a researcher consider the epidemiological principles of a design. The Guide on Methodological Standards, first published in 2012, collects the methods. Every study should be registered in the Catalogues, ideally before it starts.

ENCePP does not regulate medicines and does not assess their benefits and risks; it says so itself. It is a forum and a toolkit. The regulator that imposes a post-authorisation safety study is the Pharmacovigilance Risk Assessment Committee (PRAC) or a national authority, under the directive. Chapter 2 shows where the network’s standard meets the law’s.

Jump to: 1 Three moments 2 Your study, their standard 3 What the network adds to the law 4 Test yourself

Chapter 1

Which three moments made ENCePP what it is?

Pick a year. Each turned a good intention into a document.

2007Born of a risk strategy2012A guide, and a law to match2024The register becomes a catalogue

Born of a risk strategy

In 2007 the EMA launched ENCePP as an initiative of the European Risk Management Strategy adopted by the heads of Europe’s medicines agencies: a community for discussing the methods and conduct of non-interventional studies, on principles of transparency, scientific independence and common quality standards.

The first documents came in 2010. A Steering Group was established to oversee the network; the Code of Conduct set out who may fund a study and how its results reach the public; a Seal was introduced for studies that followed the Code.

What it left behind: a place for the researchers to agree their own rules before the law asked them to.

A guide, and a law to match

In 2012 the Guide on Methodological Standards in Pharmacoepidemiology appeared, bringing together international recommendations, key guidelines and the literature, and filling the gaps with good practice. It complemented the Checklist for Study Protocols, the tool that makes an investigator consider the epidemiological principles of a design before writing the protocol.

The same year the pharmacovigilance directive of 2010 began to apply. Its new chapter on non-interventional post-authorisation safety studies gave the regulator a protocol to endorse, a 60-day clock and a final report within 12 months; the EMA’s guidance on those studies then pointed to ENCePP’s Code and asked for the Checklist as an annex to the protocol.

What it left behind: a network standard that the regulator’s guidance cites by name.

The register becomes a catalogue

In 2024 the Catalogues of real-world data sources and studies of the Heads of Medicines Agencies (HMA) and the EMA replaced the European Union (EU) register of post-authorisation studies (PAS), the EU PAS Register, and the ENCePP Resources Database: one repository of data sources, studies, institutions and networks, where a study subject to the law is registered and where an institution becomes an ENCePP partner by ticking a box.

In January 2025 the Steering Group discontinued the Seal, used by only 84 studies since 2010, and kept its three components as the tools. Six new working groups and four special interest groups followed in 2025, on revising the Guide, on the Code and registration, on artificial intelligence and on diversity; the Guide became a living resource, and the Plenary met in Amsterdam on 1 December 2025.

What it left behind: fewer badges, one catalogue, and the tools everyone had been using anyway.

Chapter 2

Your study, their standard

A non-interventional safety study is on your desk. Two questions decide which rule applies to it: did the regulator impose it, and are you writing the protocol or reporting the results? Pick a cell.

ImposedVoluntaryThe protocolProtocol, imposedProtocol, voluntaryThe resultsResults, imposedResults, voluntary

Or the question is a different one: where the study is registered or who pays and who signs

An imposed study starts with a draft protocol to the Pharmacovigilance Risk Assessment Committee (PRAC), or to the national authority when a single Member State requested it. Within 60 days comes a letter of endorsement, an objection, or notice that the study is really a clinical trial; nothing starts before the written endorsement. The EMA’s guidance asks for the ENCePP Checklist as an annex. Directive 2001/83/EC, Article 107n; ENCePP, Checklist

A study the holder runs on its own initiative needs no endorsement, but the directive still applies: it must not promote the medicine, payments to health professionals are limited to time and expenses, and an authority may ask for the protocol. The standard of design is the network’s: the Checklist for Study Protocols and the Guide on Methodological Standards. Directive 2001/83/EC, Article 107m; ENCePP, Checklist and Guide

An imposed study ends with a final report to the PRAC or the national authority within 12 months of the end of data collection, unless waived in writing, with an electronic abstract. The holder must judge whether the results touch the authorisation; the PRAC may recommend a variation, suspension or revocation. Directive 2001/83/EC, Articles 107p and 107q

A voluntary study also owes its final report, within 12 months, to the authorities of the Member States where it ran, and any finding that changes the risk-benefit balance must be reported at once. The Code adds what the law does not: protocols and results are made public, whatever the study’s funding. Directive 2001/83/EC, Article 107m(6) and (7); ENCePP, Code of Conduct

Every study is registered in the HMA-EMA Catalogues of real-world data studies, ideally before it starts; a study the law requires is registered there to comply with it. The Catalogues replaced the EU PAS Register in 2024 and hold the data sources, institutions and networks as well. ENCePP, Code of Conduct; HMA-EMA Catalogues

Who pays, who decides and who signs the publication is the Code of Conduct’s subject: rules for the relationship between investigators, funders and contract research organisations, from protocol agreement to publication, for any study financed from outside. Launched in 2010, revised for the fourth time in March 2018, it is the text the EMA’s guidance on safety studies refers to. ENCePP, Code of Conduct

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.
ENCePP, Code of Conduct, shortened

The law obliges the holder of an imposed study to report. The network asks every study, imposed or not, to be seen.

Chapter 3

What does the network add to the law?

The directive governs the studies a regulator imposes. Five places where ENCePP wrote what the directive left open.

	The law	The network
How a protocol is judged	Endorsed or refused within 60 days	A checklist of epidemiological principles, annexed to the protocol at the EMA’s request
The methods	Nothing	A guide first published in 2012, now a living resource, revised by a working group
Who funds and who publishes	No promotion, and payments limited to time and expenses	A Code of Conduct on independence and transparency, from protocol to publication
The register	Registration of studies subject to regulatory requirements	Every study, ideally before it starts, in the Catalogues
The people	A holder, an authority, a committee	Research centres, hospitals and data holders across Europe, meeting once a year

Show the references

How a protocol is judged: Directive 2001/83/EC, Article 107n(2); ENCePP, Checklist for Study Protocols.
The methods: ENCePP, Methodological Guide.
Who funds and who publishes: Directive 2001/83/EC, Article 107m(3) and (4); ENCePP, Code of Conduct.
The register: HMA-EMA Catalogues, home page; ENCePP, Code of Conduct.
The people: ENCePP, Q&A; ENCePP, How we work.

The directive tells a company when to report a study. ENCePP tells everyone how to run one worth reporting.

The facts, in one place

What it is	A voluntary network, coordinated by the EMA, of public institutions, networks and contract research organisations doing research in pharmacoepidemiology and pharmacovigilance.
Since	2007, launched by the EMA as an initiative of the European Risk Management Strategy adopted by the Heads of Medicines Agencies.
Who decides	A Steering Group of 20, six elected by the Plenary, on three-year terms; the EMA provides the Secretariat; temporary working groups deliver the work plan.
Partners	Public and not-for-profit bodies in the EU or the European Economic Area, and contract research organisations working for others; not pharmaceutical companies. Partners meet once a year at the Plenary.
Tools	The Code of Conduct (2010, revision 4 in 2018), the Checklist for Study Protocols, the Guide on Methodological Standards (2012, now a living resource).
Register	The HMA-EMA Catalogues of real-world data sources and studies, which replaced the EU PAS Register and the ENCePP Resources Database in 2024.
Retired	The ENCePP Seal, introduced in 2010 and discontinued in January 2025 after 84 sealed studies.

Don’t confuse it with: the HMA-EMA Catalogues

ENCePP

The network

Is: the research centres and their Steering Group, coordinated by the EMA
Gives: the Code, the Checklist and the Guide, and a yearly Plenary
Example: a working group revises a chapter of the Guide

The Catalogues

The register

Is: a repository of data sources, studies, institutions and networks
Gives: a record for every study, required by law for some and asked by the Code for all
Example: a holder registers an imposed safety study before it starts

Chapter 4

Test yourself

Myth or Truth? Pick an answer to see the explanation.

“A pharmaceutical company can become an ENCePP partner.”

MythTruth

MythYou got it.Not quite.

Pharmaceutical companies cannot be partners, though they are encouraged to use the tools. Partners are public and not-for-profit bodies, and contract research organisations working for others.

“An imposed safety study may not start until the Pharmacovigilance Risk Assessment Committee (PRAC) or the national authority has endorsed the protocol in writing.”