Euro Roundup: EMA and African counterpart create guidance on Ebola vaccine clinical trials
The European Medicines Agency (EMA) and its African counterpart have published a joint position paper to support the timely start of Ebola vaccine clinical trials.
Working with the African Medicines Agency (AMA), EMA has developed advice for companies developing vaccines against Bundibugyo virus (BDBV), the Ebola-causing pathogen driving the current epidemic. The ongoing public health emergency in the Democratic Republic of the Congo, as well as cases in Uganda, Kenya, and Nigeria, means BDBV vaccines must move through the clinic as quickly as possible, EMA said.
To support that goal, EMA and AMA have outlined the minimum requirements for starting BDBV vaccine clinical trials and provided advice on study design. The position paper also encourages timely approval of trials by African national regulatory authorities to accelerate vaccine development.
Under the position paper, sponsors can postpone or waive some animal toxicity studies of vaccines based on well-characterized platforms, such as mRNA and certain viral vectors. Rather than run the studies, sponsors can rely on existing data showing different antigens do not adversely affect the overall safety profile. Biodistribution studies could also be waived based on prior knowledge.
However, preclinical testing may be needed with established platforms in certain circumstances, such as when the new antigen has known inherent toxicity or mimics a human protein that could trigger severe autoimmunity. Vaccines that use a drastically higher dose or a different route of administration than predicate products may also need to undergo preclinical tests.
The agencies recommend running non-human challenge studies to ensure that vaccines have a chance of being effective before they enter phase 2/3 trials. The cynomolgus macaque model is the gold standard for testing filovirus vaccines, but the shortage of laboratories able to conduct such studies has created a bottleneck. Developers have investigated alternative models, notably using ferrets, but EMA and AMA are unsure to what extent vaccine immunity in the animals resembles the human immune response.
EMA and AMA are advising sponsors to perform early clinical trials in Africa when possible to make the transition to larger efficacy studies in affected populations as efficient as possible. Sponsors that run first-in-human tests in other regions should consider setting up studies in Africa, either as separate clinical trials or as part of a seamless phase 1/2/3 program.
The agencies proposed phase 3 platform studies to assess whether vaccination prevents Ebola. Multiple vaccine candidates could potentially be tested in the same trial, enrolling people who have been in close contact with a confirmed Ebola case to determine efficacy. Sponsors should start enrolling children and pregnant women once initial safety data from adults are available.
Council of Europe shares position on manipulating human organs outside the body
A Council of Europe committee has published a position paper on manipulating human organs outside of the body before transplantation.
The European Committee on Organs, Tissues and Cells (CD-P-TO) created the position paper to propose a regulatory approach to ex situ organ manipulation. The proposed approach aims to ensure that the existing legal framework and ethical principles governing transplantation apply to organs manipulated outside of the body.
CD-P-TO has proposed a clear distinction between donated human organs and the technologies used to manipulate them. Under the position paper, a donated organ remains an organ, regardless of how it has been manipulated. The assertion prevents the risk that donated organs could become subject to pricing, exclusivity, and other commercial incentives.
The committee made recommendations intended to inform a European model that supports responsible technological innovation while ensuring established donation and allocation systems apply to manipulated organs. Under the model, clinical criteria and medical need will continue to guide access to organs, whether manipulated or not.
CD-P-TO outlined its position in response to the rise of technologies that facilitate the assessment, repair, and treatment of human organs outside the body. Such innovations can enhance the viability of donor materials, potentially increasing the number of organs available and improving patient outcomes. However, the developments raise questions about the regulatory status of manipulated organs.
Swissmedic updates eCTD v4.0 implementation guide ahead of 2027 start date
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guide for implementing version 4.0 of the electronic common technical document (eCTD).
Swissmedic plans to complete the technical implementation of eCTD v4.0 by the end of the year. The standard is scheduled to go live in 2027, once pilot testing is complete. Swissmedic aims to ensure compatibility with international regulatory authorities’ authorization application requirements. The agency will continue to support eCTD v3.2.2 for several years.
To help affected companies, Swissmedic published version 1.1 of its implementation guide in July. This week, the agency released version 2.0 of the guide. The new package, which replaces version 1.1, includes an updated implementation guide, a list of the required controlled vocabulary, and validation criteria.
Swissmedic is accepting suggestions and feedback, particularly concerning the technical documents in the updated package. Affected organizations can share responses to the package through appropriate contact channels at any time. Swissmedic will continue to provide updates on its progress.
European Commission adds Singapore to list of recognized third countries for APIs
The European Commission has added Singapore to the list of recognized third countries for imports of active pharmaceutical ingredients (APIs).
Under the European Union’s Falsified Medicines Directive, API imports must typically be accompanied by written confirmation from the competent authority of the exporting country. The confirmation must attest that the standards of good manufacturing practice and control at the API production site are equivalent to those in the EU.
Third countries can ask the Commission to assess whether their regulatory framework, together with related API control and enforcement activities, ensures a level of public health protection equivalent to that of the EU. Singapore submitted a request in February 2025.
The Commission reviewed documents submitted by Singapore’s Health Sciences Authority and performed an on-site review of the country’s regulatory system. Based on the review, the Commission added Singapore to the list of recognized third countries. Singapore is the first country to join the list since the Commission added Taiwan almost three years ago.
Other News:
EMA has updated its notice to sponsors on the validation and qualification of computerized systems used in clinical trials. The update reflects the Clinical Trials Regulation and the revised International Conference on Harmonisation (ICH) guideline for good clinical practice. EMA has added three bullet points on the requirements of ICH E6(R3). EMA Notice
The UK has moved to eliminate the value-added tax (VAT) charge on medicines that companies provide free of charge. Previously, companies could face a VAT bill on medicines provided for free through early access and compassionate-use programs. Industry groups have argued the bills created a tax barrier to the provision of free medicines to patients who have limited treatment options. ABPI Notice
EMA has updated a question-and-answer document on good manufacturing and distribution practices. The agency revised its answer to a question about the requirements for batch numbers on the packaging of medicinal products subject to parallel trade. In the absence of national legislation or guidance, the outer packaging should carry a single batch number allocated by the parallel trader. EMA Q&A
