Euro Roundup: EMA shares guidance on CTR, confidential data as new rules take effect

The European Medicines Agency (EMA) has published a quick guide to the rules and procedures of the Clinical Trials Regulation (CTR) alongside questions and answers on protecting commercially confidential information when using the Clinical Trials Information System (CTIS).
 
Use of CTIS became mandatory on 31 January, turning the system into the single point of entry for the submission and assessment of clinical trial data.
 
The quick guide covers the basics of CTR, explaining the key principles of the regulation before walking through the steps sponsors should take before starting clinical trials. EMA explains how to register users, products and organizations and submit clinical trial applications via CTIS, as well as the assessment and decision process by member states.
 
Subsequent sections cover the steps sponsors need to take during and after clinical trials, covering filing applications for modifications, safety surveillance, reporting adverse events and, once the study is over, the submission of notifications via CTIS and the summary of the results. 
 
Another section describes the transparency implications of CTR, explaining that the regulation “brings unprecedented standards for transparency and publication of clinical trials data in the European Union.” The transparency section describes the process for delaying the publication of clinical trials documents and data to protect commercially confidential information.
 
A companion document answers common questions about protecting information and data when using CTIS. The Q&A is intended to provide clarity on the main discussion points at the Clinical Trials Coordination Group and the comments raised in a public consultation last year.
 
EMA has split the document up into sections about deferrals, personal data and commercial confidential data. The responses explain how sponsors can mark information they consider to be confidential, the rules on deferring publications during public health emergencies and which CTIS documents require a signature.
 
CTR Guide, CTIS Q&A, Press Release
 
Commission seeks feedback on safeguarding the welfare of animals used for scientific purposes
 
The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) is gathering feedback to inform its opinion on planned changes to the rules on the protection of animals used for scientific purposes. SCHEER provides opinions on risks at the request of the European Commission.
 
The committee is asking interested parties to provide scientific information about the standards of accommodation and care to safeguard the welfare of zebrafish when kept in captivity for research use, particularly key parameters and respective ranges for zebrafish housing and maximum stocking densities.
 
The second topic covers the methods of killing that are appropriate for animal bred, supplied or used in scientific procedures, including the conditions and limitations of hypothermic shock. Finally, SCHEER is requesting information on the housing requirements needed to maintain the welfare of certain birds that are kept in captivity for scientific purposes.
 
The deadline for submitting information is 27 February. SCHEER will keep the call for information open and accept data from ongoing studies after that date if needed. 
 
Feedback Request
 
European Parliament proposes changes to Commission regulation on substances of human origin
 
The European Parliament has called for changes to the proposed regulation on substances of human origin (SoHO), highlighting requirements that it sees as “too burdensome and difficult to implement” in its feedback to the Commission.
 
In July, the Commission adopted a proposal on SoHO quality and safety standards. Officials designed the proposal to support the continued provision of SoHO therapies, extend protective measures to more patients and improve harmonization across member states. Now, the Parliament, one of the bodies that needs to sign off on the plans, has provided feedback.
 
The suggested changes to the text include limiting the situations in which organizations need to obtain an authorization for a modified SoHO preparation to times when they have made substantial changes. The Parliament explained the thinking behind its proposal.
 
“Forcing SoHO entities to apply for a new authorization for any changes may be too burdensome and difficult to implement. The introduction of a small degree of flexibility in this article would appear to be better adapted to the reality on the ground,” the Parliament wrote. Officials proposed a change to when companies need to seek approval for changes to the chain of activities on the same grounds.


The amendments also include a request to allow member states to “introduce additional measures to help set up a European supply chain and to achieve the objective of European self-sufficiency.” The idea is to free countries to impose stricter measures to restrict imports from third countries “whose collection systems are not necessarily based on the principle of voluntary and unpaid donation.”
 
European self-sufficiency is a theme that runs through the proposed changes. The focus reflects worries about “the loss of European sovereignty in the area of public health” that emerged during the pandemic and a desire to ensure the EU has the raw materials to meet its own demand for SoHO therapeutics.
 
Parliament Proposals
 
EMA clarifies rules on biosimilars interchangeability
 
EMA has responded to questions raised by the biosimilar interchangeability statement it published with the Heads of Medicines Agencies.
 
The document clarifies that any frequency of switches, between any number of biosimilars with the same reference product, is possible because the comparability exercise makes negative consequences “highly unlikely.” The rules apply to all biosimilars. 
 
“The EU regulatory and scientific requirements for establishing biosimilarity are tailored to meet the challenges posed by differences in molecular complexities, thereby allowing for interchangeability of all EU-approved biosimilars,” according to the document.
 
However, EMA’s support for interchangeability does not mean the practice is necessarily allowed in a member state. Prescribing practices and clinical guidance are outside of the agency’s remit. What EMA can say is that interchangeability is “already taking place in some EU member states without any signs of change in efficacy or safety for the patients.”
 
EMA used the Q&A to add certain caveats to its statement on interchangeability. The statement covers the interchangeability of active substances and formulated products, but not “potential issues related to the handling of different administration devices,” such as the need to train patients to use new devices.
 
EMA Q&A
 
Other news:
 
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has published its work plan for 2023. The document lists PRAC’s key objectives for the year, such as strengthening the systematic generation of information on the benefits and risks of medicines in pregnancy and breastfeeding. EMA Notice