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Regulatory Focus™ > News Articles > 2022 > 4 > Euro Roundup: EMA shares draft guidance on protecting confidential data in CTIS

Euro Roundup: EMA shares draft guidance on protecting confidential data in CTIS

Posted 14 April 2022 | By Nick Paul Taylor 

Euro Roundup: EMA shares draft guidance on protecting confidential data in CTIS

The European Medicines Agency (EMA) has published draft guidance on protecting personal data and commercially confidential information uploaded to the Clinical Trial Information System (CTIS).
CTIS allows the submission and storage of clinical trial information to support the Clinical Trials Regulation (CTR). Through CTR, the EU has made a single-entry point for submitting data and documents related to clinical trials and created a source of publicly available information on human research.
EMA’s draft guidance sets out how to protect personal data and commercially confidential information that might be uploaded but should remain private. The guidance states that EMA, the European Commission, member states and clinical trial sponsors are jointly responsible for protecting the personal data processed in CTIS. Sponsors need to ensure “the confidentiality of records and the personal data of the subjects remain protected” and adopt “appropriate technical and organizational measures to protect information and personal data processed against unauthorized or unlawful access.”
No personal data on subjects can be publicly accessible, meaning anonymization is required. The draft guidance sets out the principle of anonymization, stating that one technique cannot meet all privacy criteria. Sponsors should consider the likelihood of successful re-identification.
Anonymization of documents labeled for publication should occur outside of CTIS and be applied consistently across all texts. The CTIS users who upload documents to the system are solely responsible for anonymization and redaction since the platform lacks a mechanism to do so.
EMA drafted the section on commercially confidential information to provide a working tool and reference document for clinical trial sponsors and other CTIS users. The section is intended to provide a common understanding of what information is considered commercially confidential and make the identification of the information across different materials more consistent.
The draft defines commercially confidential information as “any information contained in the clinical trial application, or provided during the trial life-cycle, which is not in the public domain or publicly available, and where disclosure may undermine the legitimate economic interest or competitive position of the clinical trial sponsors or marketing authorisation applicants/holders.”
Sponsors can use the deferral mechanism to request a delay in publishing some information, but there are limits on what can be held back. EMA strongly encourages sponsors to assess what information can be deferred, explaining that it is impossible to delay the publication of critical details such as the pharmaceutical form and strength of the investigational product for some trials.
The final section of the draft addresses good clinical practice (GCP) inspection reports. Inspectors can consult the clinical trial data available in the secure domain of CTIS and should consider the requested and granted deferrals when preparing their GCP reports.
Draft Guidance
EMA’s PRAC finds no link between mRNA COVID vaccines and autoimmune hepatitis
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has found no link between Comirnaty and Spikevax and the chronic severe inflammatory condition autoimmune hepatitis (AIH).
PRAC began looking into a potential link between mRNA COVID-19 vaccines from Moderna and Pfizer-BioNTech and AIH after seeing a small number of cases in EudraVigilance and the medical literature.
PRAC reviewed the evidence, such as a report of a handful of cases in women aged between 35 and 80 years and analyses provided by the marketing authorization holders, and concluded the evidence does not warrant an update to the product information of the vaccines. EMA will continue to monitor for new reports of AIH.
At the same meeting, PRAC  discussed the risk of medication errors because of a change in the maintenance dose of Bristol Myers Squibb’s graft rejection drug Nulojix. The maintenance dose is increasing from 5 mg/kg to 6 mg/kg due to the adoption of a new manufacturing process.
“For approximately one to two months, Nulojix from both manufacturing processes will coexist on the market, and therefore two different dose recommendations will apply. A mix-up between the products may lead to medication errors resulting in over- or underdosing,” PRAC wrote. The committee asks healthcare professionals to carefully check the dose during the transition.
EMA Notice
MHRA seeks feedback on strengthening independent advisor conflict of interest policy
The UK Medicines and Healthcare products Regulatory Agency (MHRA) is seeking feedback on its process for managing conflicts of interest for independent experts.
MHRA plans to introduce a single Code of Practice for all the advisory committees, prohibit members from holding personal interests in industries relevant to their committees’ work, and publish declarations in a new Public Register of Interests. The agency proposes to exempt the British Pharmacopoeia Commission from the ban on holding interests in industries relevant to its work.
To help potential members navigate the rules, MHRA is planning to create a Code of Practice Conflict of Interest Advisory Panel to offer advice on the interpretation of the Code. The proposed Code will provide details of a conflict-of-interest panel process for potential breaches and sanctions of members who are found to have breached the code.
MHRA is accepting feedback via its website for six weeks, starting from 12 April.
Press Release
Ireland’s HPRA simplifies labeling mock-up review procedure to accelerate licensing
Ireland’s Health Products Regulatory Authority (HPRA) has simplified its labeling mock-up review process to accelerate licensing and provide greater predictability for applicants planning product launches.
HPRA currently reviews the layout, design, and readability of the labeling mock-ups, enabling applicants to submit the materials during the new application procedure. Early submission will allow HPRA to review the materials in advance and approve mock-ups simultaneously as licenses or to issue a permit and then finalize the mock-up before marketing.
Companies can change the labeling text as required during the application procedure without resubmitting the amended mockup. Resubmission is only needed if there are significant changes to the design. 
HPRA Notice
Medicines for Europe pushes for dedicated pathway for repurposed medicines
Medicines for Europe have called for a dedicated regulatory pathway and incentives for repurposed drugs to encourage more repurposing of existing molecules.
With EU pharmaceutical legislation under revision, the off-patent drug trade group calls for lawmakers to recognize “value-added medicines” such as repurposed molecules as a distinct class of products.
“The legislative recognition of VAMs should lead to the creation of a dedicated regulatory pathway and the possibility of appropriately rewarding the investment and resources dedicated to developing a medicine based on a well-known substance, including by introducing proportionate regulatory incentives,” Medicines for Europe wrote in a report on the topic.
Press Release


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