Quality & Compliance
Safety & Vigilance
13 september 2023
The EMA developed Policy 0070. It became effective on the 1st of January, 2015, and applies to centrally authorized medicinal products. The policy was suspended in December 2018 because of the relocation of EMA from London (UK) to Amsterdam (the Netherlands). After some delay, mainly due to the COVID-19 pandemic, EMA is now relaunching Policy 0070 as of September 2023.
There is growing demand from stakeholders and the public for additional transparency on medicinal products. Therefore, EMA aims to publish clinical data from pharmaceutical companies supporting their marketing authorization application (MAA) while ensuring patient privacy and protection of commercially sensitive information.
The clinical data published include the Clinical Overview & Summaries, the Clinical Study Reports & appendices.
Important: Policy 0070 applies to all clinical data submitted to EMA, regardless of the outcome of the regulatory procedure. Hence, it includes rejected and withdrawn applications, too.
EMA will not publish clinical data without consulting with the applicant first. The applicant needs to supply EMA with the redacted clinical data set. EMA reviews the company’s redaction proposals and provides recommendations. The company then submits the revised documents per EMA’s recommendations, and the Agency publishes the final version.
The applicant may redact clinical data documents for two reasons:
Although Policy 0070 remains primarily unchanged compared to 2015, several updates have occurred.
Step 1 applies to new active substances that receive an opinion from the Committee for Medicinal Products for Human Use (CHMP) from September 2023 and products that will receive a negative CHMP opinion or products for which the application is withdrawn. Important: There is no plan to request clinical data for products authorized during the suspension of Policy 0070.
Step 2 covers the full scope of Policy 0070 (including biosimilars, generics, Article 58 applications, extension of indications, and line extensions) and is planned for 2024. More information will follow in due time.
Applicants with ongoing initial marketing authorization applications (MAA) for a new active substance with a planned CHMP Opinion date from September 2023 onwards will receive an invitation letter from EMA to submit an RPDP ≤ 90 days before the planned CHMP opinion date.
For initial MAAs, the timeline to provide EMA with the RPDP is Day 181 to ≥ 30 days post-opinion. For other kinds of applications, please see the EMA Q&A guidance document.
The main steps of the end-to-end process for the publication of clinical data documents are:
|Submission of Redaction Proposal Document Package (RPDP) by the applicant
|Receipt of RPDP by EMA clinical data publication team
|Validation outcome sent to the applicant.
|The redaction conclusion (including the conclusion CCI assessment and recommendations/comments anonymization report) is sent to the applicant.
|Applicant provides written agreement on Agency’s redaction conclusion on CCI.
|Upon request, the applicant provides an updated anonymization report and/or written responses on the recommendations/comments on the anonymization report.
|Submission of Final Redacted Document Package (FRDP) by the applicant
|Publication of FRDP
The Redaction Proposal Document Package should contain:
|List of documents submitted, annexed to the cover letter
|Clinical overview (Module 2.5) – supplement/amendment/appendix
|Clinical summary (Module 2.7.1. – 2.7.4.) – supplement/amendment/appendix
|Clinical study report – body (Module 5.3)
|Clinical study report – Appendices (Module 5.3)
16.1.1 protocol and protocol amendments
16.1.2 Sample Case Report form
16.1.9 documentation of statistical methods
|Set of justification tables (CCI redactions only) detailing all proposed redactions for each document
|Anonymisation Report – Structured fields template will be available soon
After consultation with EMA and possible updating of the documents, the Final Redaction Document Package is submitted (see Redaction Consultation process, Day 74). Items 3, 4, 5, 6, and 8 will be published (see the items colored in yellow in the Table above).
EMA Clinical Data Portal: https://clinicaldata.ema.europa.eu/web/cdp/home.
Start in time: The Clinical Data Publication review process runs parallel with the Centralised Procedure and can pose an extra burden. To avoid delays during pending procedures, we recommend reviewing the list of documents in EMA’s Invitation Letter, preparing the package, and deciding on the anonymization approach and whether this will be done in-house or outsourced.
Alternatively, you can pro-actively apply the CCI and PDD requirements and principles while writing the CSRs, including appendices and the Clinical Overview and Summary. It means you are already prepared at the start of the Centralised Procedure.
The PPD/Anonymisation is the bulk of the work, as all the documents defined by the EMA for clinical data publication need to be reviewed for PPD. It is necessary to perform a thorough quality check to ensure the risks of patient reidentification are being suitably mitigated while allowing for optimal data utility for the users of the published clinical data documents. This strategy needs to be sufficiently described in the Anonymisation Report. Reserve enough time to do this task.
CCI justification is critical: Ensure that any CCI proposed is not already in the public domain. Proposed CCI claims need to be very detailed, relevant, and specific, and the justification needs to indicate how it would undermine your economic interest for each redaction proposal. Justifying that a piece of information is considered CCI in documents already published on CTIS (Clinical Trials Information System) is insufficient. As per CCI Covid clinical data publication experience, the percentage of CCI within the documents has been very small: 0.01 %.
We have experience with the Redaction Consultation process from start to finish and can support you as needed. If you want us to take care of the complete Policy 0070 process, we can. We have experienced teams of medical writers and regulatory experts who write clinical data documents with Policy 0070 in mind.
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