On May 16th, 2023, EMA conducted a much-awaited webinar to address the phased restart of EMA Policy 0070 after almost five years of suspension. The restart will come into effect in September 2023.
The EMA initially introduced the clinical data publication Policy 0070 in 2014, intending to make clinical trial data more accessible to the public. The policy was on hold since 2018 due to and, later, due to the pandemic.
This policy has played a crucial role in enhancing transparency in clinical trial data by allowing public access to clinical reports submitted by pharmaceutical companies.
A restart is a befitting response to critics who hinted that the policy may be scrapped. With this news, EMA has highlighted its continued commitment to data transparency in clinical research.
This is what we need to know about the timely revival of Policy 0070 soon:
Scope:
A phased restart to publish clinical data for marketing authorization applications (MAAs) involving new active substances (initial, line-extension, extension of indication, withdrawn) that will receive the EMA’s Committee for Medicinal Products for Human Use opinion (irrespective of decision) from September 1st, 2023, onwards. EMA will send invitation letters to begin the process for valid applications starting in June 2023.
Timelines:
Sponsors will be provided with an updated Q&A, Submission checklist, and draft list of documents in scope publication at the time of the invitation email from EMA on Day 121.
For the Initial MAAs, and line extension applications, sponsors need to submit their Redaction Proposal Document package between Day 181 and 30 days after CHMP opinion, which was previously stringent. EMA also relaxed the procedural timelines for other in-scope applications:
- For Article 58 applications, the Redaction Proposal Document package is requested within 60 days post-CHMP opinion.
- For extension of indication applications, the Redaction Proposal Document package is required within 30 days pre-CHMP opinion to 30 days after CHMP opinion, which was ≤ 10 days post-opinion.
- For withdrawn applications, prepare to submit the Redaction Proposal Document package ≤ 60 days post-receipt of the withdrawal letter by EMA.
Structured Anonymization Report (AnR) template:
Tick boxes, data tables, drop-down lists and limited free text will be the key features of the updated AnR template, which will be made available in September 2023. With these, EMA aims to ease the process of drafting and reviewing. These align with the current EMA Policy 0070/Health Canada joint AnR template.
Company Confidential Information (CCI) Acceptance Ratio:
EMA pointed out that the CCI acceptance ratio stayed low in the recently published submissions during the COVID-19 pandemic (0.01%) and reiterated the need for a thorough public domain search to avoid rejections on proposed CCIs. They look for detailed justification and a clear CCI strategy in the package.
EU Clinical Trial Regulation (EU-CTR) along with Policy 0070:
Policy 70 and Clinical Trial Information System (CTIS) teams are working towards a common guidance document while continuing to work on the differential scope and procedural timelines to improve clinical research transparency.
The relaunch of EMA Policy 0070 marks a significant step towards publishing clinical data on the EMA portal. The revival is highlighted with an enhanced framework, streamlined data release, and improved redaction procedures to strengthen the policy’s impact. EMA P70 and EU-CTR will act as a dual engine to fuel EMA’s long-term vision of advancing transparent clinical research in the European Economic Area (EEA).
At MMS Holdings, we stand ready to guide you through the phased restart of EMA Policy 0070, a significant shift in clinical research transparency. If this regulatory change impacts your business, our expertise can help you navigate with confidence. To explore how we can support your specific needs and align your strategies effectively, please click here to start a conversation with our experts today.
