Support

The ENCePP Resources Database and the EU PAS Register® were established in 2010 to facilitate the exchange of information on observational research. Launched to meet technical requirements at the time, these platforms have limitations hindering their adaptability to current needs. The 2012 EU pharmacovigilance legislation mandated Marketing Authorization Holders to register some Post-Authorization Safety Studies (PASS), and the EMA to publicly disclose their protocols and abstracts. Subsequently, EU Good Pharmacovigilance Practices Module VIII recommended registering all other PASS in the RMP. Constraints have limited upgrades since 2012. The new platform addresses these constraints for enhanced functionality. 

Additionally, the Big Data Steering Group has issued recommendations towards increasing data discoverability and strengthening EU network processes. Specifically, the recommendation targeted a rebuild of the current EU PAS Register and the creation of a data source. 

Yes, the ENCePP still exists and continues its work. However, the EU PAS Register and the ENCePP Resource Database have been migrated from the ENCePP website to the EMA website. More information on ENCePP and its mandate can be found on the updated ENCePP website. 

All study records have been migrated to the Catalogue of RWD studies and are no longer published anywhere else. Similarly, networks and centres (also known as institutions) have also been migrated to the Catalogues and are no longer published anywhere else. Data sources who have confirmed migration to the Catalogue of RWD sources have been migrated; the remaining data sources have no longer their record published anywhere. EMA has kept an archive of all legacy records in the ENCePP Resource database and the EU PAS Register.  

All contacts available in the EU PAS Register and the ENCePP Resource Database have been contacted with information on the RWD Catalogues and the migration, with a request to create an EU Login account and claim their records. If you were unable to claim your record, please follow the steps below:

• If you do not yet have an EU Login account, please follow the steps to create an EU Login account: EU LOGIN (europa.eu).  
• To ensure your records are assigned to your (new) EU Login account, please enter the email address used to create your EU Login account and list the record name(s) and acronym(s) of data sources/networks/institution and/or titles and EU PAS Register numbers of study records that you wish to claim and link to your account using the following link: https://ec.europa.eu/eusurvey/runner/EMA-HMA_Catalogues.  
• Once you have filled in the survey, log in to the RWD Catalogues website. Logging in for the first time is a necessary step in order for us to assign your claimed record(s). Click the ‘log in’ button in the top right-hand corner of the website. use your EU Login credentials (email and password) to login. Please note, a multi-factor authentication step will be required. Please refer to the user guide for instructions on how to use the multi-factor authentication using the EU Login Mobile App. To install the EU Login App, please see instructions at page 20 of the user guide.  
• Once logged in, you should see your (empty) dashboard. You may now log out again and close the window. Your records will be assigned to you in due course, and can take up to 10 days. 

Please be aware that it is only possible to access information previously registered in the ENCePP Resource Database and EU PAS Register (data source, network, centres, or studies) within the RWD Catalogues if you have completed the survey: https://ec.europa.eu/eusurvey/runner/EMA-HMA_Catalogues 

IMPORTANT: If you have already claimed your record in the survey, please proceed to log in to the Catalogues website. Logging in for the first time is a necessary step in order for us to assign your claimed record(s) to your user account. EMA will continuously be assigning records to their owners in the weeks following the launch.  

Thank you for your patients and understanding during this transition period.  

If you have followed the above steps and are still experiencing issues locating or accessing your records, please contact us.

No, there is no cost to listing studies, data sources, institutions and/or networks in the RWD Catalogues. Similarly, there is no cost to view the information in the RWD Catalogues.  

Training courses are not provided, as most fields in the data sources, studies, institutions and networks registration forms are clarified by help texts. The following help material have been made available to support the registration of entries:  

• Good Practice Guide (public consultation version) - revised version available soon. 

• List of metadata for Real World Data Catalogues (public consultation version) - revised version available soon

Questionnaires for offline use and review are available here.

For any questions or issues regarding the RWD Catalogues, please submit your ticket via EMA’s service desk. Please refer to the contact us page and follow the steps to raise a ticket.   

No, as the EU PAS Register has been replaced by the Catalogue of RWD studies, the EU PAS Register email address and mailbox is no longer functional or monitored. Please raise any questions via the contact us page. 

No, login details are now managed by the EU login service from the European Commission. You need an EU Login account to be able to access, submit, and edit records in the Catalogues.   

For more guidance on how to create an EU login account: Help (europa.eu) 

In the top-right hand side of the header on the RWD Catalogue website, click on the 'Log in'; you will be directed to the EU Login webpage. On this page, choose the 'Create an account' option. After providing your personal information (First name, Last name and Email), you will receive an email with instructions to activate your account. 

For more guidance on how to create an EU login account: Help (europa.eu) 

A multi-factor authentication step is required in order to log in to the RWD Catalogues website. Please refer to the user guide for instructions on how to use the multi-factor authentication using the EU Login Mobile App. To install the EU Login App, please see instructions at page 20 of the user guide.  

For more guidance on how to create an EU login account: Help (europa.eu) and (Video) EU Login: 2-factor authentication (2FA) for more security (europa.eu).

No, you do not need to create an account to view the published information in the RWD Catalogues. The Catalogues are publicly available, allowing anyone to conduct searches, view listed entities, and download information without the need for an account. 

No, if you already have an EU Login, you can login to the RWD Catalogues with those credentials. Please note, a multi-factor authentication step will be required. Please refer to question 11 for guidance on the multi-factor authentication step. 

In the EU Login portal, enter your email address and click 'Next'. On the new page, you will find the 'Lost your password?' hyperlink; click on this link and follow the stepts. 

Please enter your old email address in the EU Login portal. After successful login, hover your mouse over your name in the upper right corner. Choose 'My Account' and then proceed to the 'Configure my account' section. Here, you can update your preferred name, email address, and account settings. 

As a data owner, we recommend reviewing the information that you have previously submitted to the ENCePP Resource Database has been migrated to the Catalogue of RWD sources to ensure the information is accurate and up to date. As there are also new fields introduced in the RWD Catalogue, we recommend that you add the information that was not provided before in the ENCePP Resource Database. A summary of the new fields is available here: List of metadata for Real World Data Catalogues.  

While every effort has been made to migrate data accurately and completely, a careful review of the studies data by the primary investigator (or the study record editor) is encouraged.  

Studies finalised at the time of the data migration (22 January 2024): EMA completed the additional study fields based on publicly available information, (e.g., study protocol if available).  

Ongoing and planned studies: it is expected from the primary investigator (or the study record editor) to fill in the new fields at the earliest opportunity. 

We recommend reviewing the information you have previously submitted to the EU PAS Register has been migrated to the Catalogue of RWD studies to ensure the information is accurate and up to date. As there are also new fields introduced in the Catalogue, we recommend that you add the information that was not provided before in the EU PAS Register. A summary of the new fields is available here: List of metadata for Real World Data Catalogues. 

The EU PAS Register numbers have been migrated and preserved in the Catalogue of RWD studies. The EU PAS Register number remains visible on the study entry.  

Similar to the process in the EU PAS Register, an EU PAS Number will be automatically generated and assigned when a new study entry is drafted. The name of this study record identifier in the Catalogue of RWD studies remains EU PAS Register number.  

The EU PAS Register numbers have been migrated and preserved in the Catalogue of RWD studies, therefore, there is no need to change any references to the assigned EU PAS Register number.  

Similarly, the previous hyperlinks from EU PAS Register will be re-directed automatically to each migrated study new web address. However, please note that there is a delay of several weeks in deploying this feature post go-live date.  

The ID is a uniquely generated number that identifies every record type within the Catalogues (i.e., studies, data sources, institutions, and networks). It serves as a component for database management, ensuring data integrity and enabling seamless operations within the back-end of the Catalogues. The EUPAS Register Number, which was used to identify studies registered in the old EU PAS Register, has been migrated and preserved in the Catalogue of RWD studies. Please note that the Study ID and EU PAS Number are not necessarily identical for a study record, but both can be used to uniquely identify your study. 

All EU PAS Register studies have been migrated to the Catalogue of RWD studies, including planned, ongoing and finalised studies. 

List of networks and institutions (previously known as centres) have been reviewed and duplications have been deleted before migration to the RWD Catalogues.  

Only data sources (from ENCePP) who have confirmed migration to the Catalogue of RWD sources have been migrated. Data sources who have not been migrated to the Catalogue of RWD sources still have the opportunity and are strongly encouraged to submit their metadata in the RWD Catalogue.

The centres can be found under ‘Institutions’, while networks can be found under ‘Networks’. 

The use of a general/corporate mailbox for registration will no longer be possible due to the improved and secure EU login features (e.g. multi-factor authentication process). Records that have been registered to a general company email address in the EU PAS register must be assigned to individual accounts. 

General communication was sent out to all ENCePP users to claim their records indexed in the EU PAS Register and/or the ENCePP Resource Database in order to access these records once the new RWD Catalogues are launched. If you have not managed to claim your records, you can still do so by following these steps:  

1. Please identify records registered under your company/corporate email address and assign these to individual EU login accounts. Please provide one single e-mail address in the survey. 
2. Refer to question 4, and follow the steps to claim your records. 

The steps to enter information are the following, and are the same for all entities: 

Go to “My dashboard”> “Add content” >”+ study/data source/institution/network” > Edit webform page. When you have uploaded the desired information, click on “Save”. When you wish to submit information for EMA review, change the state from “Draft” to “Submitted” at the bottom of the page and click on “Save”. 

No, in order to save a record as a draft, or to submit a record, you must complete all mandatory fields (marked with a red asterisk). The registration of studies and data sources comprise of several steps which need to be completed. The system does not automatically save the data that is entered.  

Identifiers are assigned automatically to records for each entity and are not editable. All entities have two IDs – one numeric and one PURI (persistent unique referenceable identifier). Additionally, studies also have an additional identifier named ‘EU PAS number’ – this identifier has been migrated from the previous EU PAS Register for studies registered prior to February 2024 and is newly generated for studies registered from February 2024 onwards.   

You can refer to the List of metadata for Real World Data Catalogues for the list of fields in the Catalogue of RWD sources and studies. Please note that this is the version that was used for the public consultation in 2022. An updated version of the metadata list is expected. The fields can be also reviewed offline in the Questionnaires. 

Mandatory data fields are marked with a red asterisk. As a best practice, we recommend that you make the submission as complete as possible. 

Once your record is submitted, a confirmation message will appear on your screen, and the moderation state of the record will change to "Submitted" in your dashboard. 

Additionally, a notification email will be sent to all record authors regarding the record submission. Once the submission is reviewed and validated by EMA, you will receive a separate email notification regarding the validation outcome. The validation procedure can take up to ten (10) working days.

Please note that the notification emails will be sent from the domain: fpfis.tech.ec.europa.eu.

An Editor (called 'author' or 'co-author' in the system) is essentially the user who can add a study, institution, network, and/or data source to the RWD Catalogues and can edit their submitted entries.  

In order to have an Editor role in the RWD Catalogues, you need to create an EU login account. See FAQs on logging in. 

Once you have created your account, login to the RWD Catalogues website, after which you are automatically granted the Editor role and can submit an entry.  

To be able to add someone as co-author, you need to ensure that your co-author also possesses an EU Login account and has logged in to the RWD Catalogues website at least once in order to activate their account. Once confirmed, proceed to access 'My Dashboard' in the Catalogues and locate the specific entry for which you wish to add a collaborator, whether it's a study, data source, institution or network. When you find the entry, in the right column, click on the arrow next to the ‘Edit’ button and select 'Co-authors'.  

You will be directed to the 'Co-authors' page, where you will find an 'Add co-author' section. In this section, enter your colleague's email address. They will receive an invitation to collaborate, which they can either accept or decline. If accepted, the co-author will also be able to edit that record.  

You will be able to keep track of collaboration requests on the 'Co-authors' page under the 'Status' column. 

Please ensure the email address inserted corresponds with your colleague's EU Login account. If you have inquiries concerning EU Login, please consult FAQs on logging in. 

Before being able to collaborate with another author that has invited you as a co-author of an entry in the Catalogues, you need to accept the co-author request that has been sent to your account. To accept a co-author request, log in to the Catalogues. Once logged in, proceed to access 'My Dashboard' in the Catalogues and locate the 'My Collaboration Requests' section. Under this section, you will find the received requests. If you wish to accept the request, click on the 'Accept' button on the right. Alternatively, you can decline the request by clicking on the arrow in the button and selecting the 'Decline' option.

You will be able to change your decision at any time, as long as the main author does not remove the co-author request.

Please submit a query via the contact us page to request the transfer of the record. Please ensure the email address inserted corresponds with your colleague's EU Login account and that your colleague has previously already logged in to the RWD Catalogues website. If you have inquiries concerning EU Login, see FAQs on logging in.

Please submit a query via the contact us page to request the transfer of the record, clearly explaining the reason for the request. If possible, add the approval of the previous Editor for this transfer. 

You will need to create an EU Login account if you do not have one yet and log in to the RWD Catalogues website. At this point, your dashboard will still be empty. Once the transfer of authorship has been accepted and completed, the record will appear in your dashboard. Please allow a couple of days from time of submitting the request to the record appearing in your dashboard. If you have inquiries concerning EU Login, see FAQs on logging in.  

If your submission requires further clarifications or corrections, please consider updating the information requested and re-submit the data for validation.   

If your submission is returned, this means that it has not passed EMA’s validation process for publication, e.g., some information is missing or incorrect. Specific reasons will be provided by the EMA Validator through the revision log (in the ‘Revision’ tab).  

Once you have corrected the information in the web form, the record can be saved as a draft or can be submitted again. If you have any questions about the justification/explanation for the returned/rejected entity, please contact us via contact us page including the reference to the relevant entry.   

The messages are available in the 'Revision information'. You can also add a free text message describing the changes made, called ‘Revision log’, or a message related to the submission for the attention of the EMA Validator. 

The Publication status indicates whether the record has been published in the RWD Catalogues for public viewing. The publication status can be 'Published' or 'Unpublished'. 

The Moderation status reflects the current status of the record (in addition to the 'Publication status'), that can describe the record’s last version saved as:  

• Draft 

• Submitted (for publication) 

• Published 

• Returned (by the EMA Validator) 

• Unpublished (by the EMA Validator from the public website via request only).  

In order to delete your record, send a request via the contact us page. In your query, add a justification for the request to delete. As best practice and for transparency reasons, study entries are not deleted from the Catalogue unless adequate justification is provided. If a study is terminated or not proceeding as planned, the entry will remain visible to the public with relevant explanations.

All record submissions are reviewed and validated by the EMA before being published in the RWD Catalogues. The validation process can take up to 10 working days. Once your submission is published, you will receive an email notification (from the domain: fpfis.tech.ec.europa.eu). The published record will become available on the public website, and the 'Moderation status' of your record in your dashboard will change from 'Submitted' to 'Published'.

If more than 10 working days have passed since your submission, please contact us via contact us page.

There are no strict timelines associated with the re-submission of information. However, we recommend to re-submit the requested additional information/data, where possible, within two weeks.  

• Data sources with institutions: The list of data sources belonging to an institution (i.e., the data holder) can only be added through the data source record. When editing a data source record, you need to fill the 'data holder' field with the associated institution(s). The institution records will automatically appear in the linked data sources.  

• Data sources with studies: The list of data source used in a study can be added in the study record. When editing a study record, you need to fill in the data sources field. The data source record will automatically appear in the linked studies.  

• Studies with institutions: The list of institutions associated with a study can be added in the study record. When editing a study record, you need to fill in the institution field. The institution record will automatically appear in the linked studies. 

• Studies with networks: The list of networks associated with a study can be added in the study record. When editing a study record, you need to fill in the network field. The network record will automatically appear in the linked studies. 

• Networks with institutions: The list of institutions that are part of a network can be added in the network record. When editing a network record, you need to fill in the institution field. The institution record will automatically appear in the linked network. 

Registration of non-interventional post-authorisation safety studies (PASS) conducted pursuant to an obligation imposed by a competent authority in accordance with Articles 10 or 10a of Regulation (EC) No 726/2004 or with Articles 21a or 22a of Directive 2001/83/EC is mandatory in line with the provision of GVP Module VIII on PASS. In addition, the registration of studies that wish to qualify for the ENCePP Seal is mandatory.

The Catalogue of RWD studies is open to non-interventional post authorisation safety studies (PASS), Required non-interventional PASS, and any other real-world data (RWD) studies conducted by MAHs, regulators, academia or research organisations. This includes all studies initiated, managed or financed by marketing authorisation holders, research centres and organisations (both within and outside the ENCePP network). Registration of studies is strongly encouraged and can be done at any stage (i.e., from planning to already completed). 

Yes, the Catalogue is open for registration to RWD studies, regardless of the country(ies) in which they are conducted. 

Registration of studies can be done at any stage (i.e., from planning of the study to completion of its final report). As a best practice, it is recommended to register them before the study commences (i.e., start of primary data collection or date of first data extraction for secondary use of data). 

Any designated individual (e.g., staff member of the research centre, sponsor or pharmaceutical company acting as study funder) may register the study with the agreement of the primary lead investigator. The decision of who enters the study in the Catalogue should be with the primary lead investigator who is ultimately responsible for the provided information. The individual registering a study must have an EU Login account.  

For studies where no primary lead investigator has been designated, the details of the individual person responsible for the conduct of the study should be provided and included under the section referring to the primary lead investigator. 

A study may reflect the following status: 'planned', 'ongoing' or 'finalised'. The dates automatically change in the system based on the entered study milestones. The database foresees five different study timelines, three of which are mandatory:  

1. Date when funding contract was signed: when the planned or the actual date is entered, the status of the study will be 'planned'. This is the date at which the contract between the funder of the study and the organisation in charge of conducting the study (or the primary lead investigator) has been signed. In case of multiple funding contracts, the date of signature of the first contract relating to the study should be provided. 

2. Study start date: when the actual date is entered, the status of the study will change from 'planned' to 'ongoing'. This date refers to the start of data collection. In case of primary data collection, this refers to the date from which information on the first study subject is first recorded in the study dataset. In the case of secondary use of data, the study start date is the date from which data extraction starts (NB: for multi-database studies, this is the date on which the first data extraction is performed).

3. Date of final study report: when the actual date is entered, the status of the study will change from ‘ongoing’ to ‘finalised’. For ENCePP Seal studies, it is mandatory to upload the final study report in the database when the actual date of the study report is entered. Unless the relevant 'actual dates' have been entered, automatic reminders will be sent after the planned date for the start of data collection and the planned date of the final study report. 

As outlined in GVP Module VIII, marketing authorisation holders (MAHs) are encouraged to register a PASS (either conducted voluntarily or pursuant an obligation imposed by a regulatory authority) in the HMA-EMA Catalogue of RWD studies (previously EU PAS Register) and to make the protocol available before the study commences (please see GVP Module VIII.B), as well as any updated versions of the study protocol in case of substantial amendments (as soon as possible and preferably within two weeks after their finalisation). MAHs are also encouraged to make available progress reports and the final study report, taking into account any applicable regulatory requirements.

For a definition of ‘substantial amendments’, see GVP Module VIII.B.2. Where prior publication of the protocol could threaten the validity of the study or the protection of intellectual rights, a study protocol with redactions made by the MAH may be entered into the Catalogue prior to the start of data collection. The complete protocol should then be entered in the Catalogue at the end of data collection. 

The timeline to publish the study results and the final study report in the HMA-EMA Catalogue of RWD studies (previously EU PAS Register) is at the discretion of the principal investigator, but it is recommended to upload the documents as soon as possible after their finalisation, taking into account any applicable regulatory requirements. Transparency about study results is a key element providing confidence on the governance and relevance of the study.

It is no longer possible to hide a protocol in the Catalogue of RWD studies. As a best practice, it is encouraged to publish the study protocol, as per the ENCePP Code of Conduct, prior to the start of data collection. Where prior publication of the protocol could threaten the validity of the study or the protection of intellectual rights, a study protocol with redactions may be entered into the Catalogue prior to the start of data collection. The complete protocol should be entered in the Catalogue at the end of data collection. 

Any hidden protocols in the EU PAS Register at the time of migration (22 January 2024) have not been migrated to the Catalogue of RWD studies. These protocol will need to be re-uploaded by the record owner. 

Regarding the format and content of protocol, abstract and final study report the Implementing Regulation 520/2012 provides in Annex III a clear structure which MAHs have to follow when submitting protocol, abstract and final study report to regulatory authorities for PASS imposed as an obligation. To this end the Agency has published guidance for the submission of PASS protocols on the EMA website: https://www.ema.europa.eu/documents/other/guidance-format-content-protocol-non-interventional-post-authorisation-safety-studies_en.pdf.  

Similar guidance is provided for abstracts and final study reports: https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guidance-format-content-final-study-report-non-interventional-post-authorisation-safety-studies_en.pdf.  

To ensure the same level of transparency, scientific and quality standards for all PASS, MAHs should follow the format and content requirements also when making information about PASS available in the Catalogue of RWD studies, however this is a recommendation and not a legal requirement as applicable to PASS conducted pursuant to an obligation. 

Data sources should be registered by the data holder. 

While the main focus of the Catalogue is on European data sources, any other data source can be accepted in the Catalogue. 

For the purpose of the Catalogue of RWD sources, the data holder represents the organisation maintaining the data. 

In more detail, the EHDS defines a data holder as follows: “Any natural or legal person, which is an entity or a body in the health or care sector, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies who has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation implementing Union law, or in the case of non-personal data, through control of the technical design of a product and related services, the ability to make available, including to register, provide, restrict access or exchange certain data.” 

As a visitor, you can find the search button in the top right corner of the RWD Catalogues website. This will re-direct you to the Search page. On this page, all publish entities are listed by default, sorted by last published update.  

User the filter functionality, on the left hand-side of the Search page to filter for either studies, data sources, networks or institutions.  

In the search bar you can type keywords. The system will provide suggestions based on the content indexed in the RWD Catalogues, to help you focus the search and minimise typing errors. The filter functionality also had additional filter available and will adapt based on the search results. To clear the filters applied, select 'clear'. To apply the filters and perform the search, select 'apply'.  

Proposals for improvement are welcome and encouraged. When putting forward a proposal please describe also the rationale and the use case supporting it. 

We would recommend to first check the Release notes <link> and then send the proposal for improvement viathe contact us page. 

To export data, follow these steps: 

1. Click on the 'Search' button located in the upper right corner.  

2. Click on the 'Filter Options' on the left. 

3. Choose the specific record for which you want to export information (institution, data source, study, or network), then click on 'Apply'. 

4. Click on the ‘Export Results’ button in the top left corner of the Results header to initiate the export process. The exported file will be in .csv format. 

In the latest version of Microsoft Excel (2023), you can import the .csv file as a table. Please follow these steps: 

1. Open Microsoft Excel with a new, empty workbook.  

2. In the menu, choose the 'Data' option. 

3. Under the 'Get & Transform Data' section click on 'From Text/CSV'. 

4. A dialog box will appear, allowing you to select the .csv file you want to open.  

5. Select the file and the Excel will import it as a table.