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These highlighted activities include priority working areas of Enpr-EMA and its working groups. For more details and regular updates on Enpr-EMA activities, see also Enpr-EMA's regular newsletters.
EnprEMA has established a working group to address cross-border access to paediatric clinical trials.
The group focuses on the challenges that make it harder for patients from other countries to take part in studies, as well as ethical concerns around rules that exclude patients based on the language they speak or where they live.
To better understand these issues, the group reviewed study protocols from public registries and gathered survey feedback from trial sites, patients, and sponsors.
The findings showed that language requirements are common, and many trial sites do not yet have the systems needed to support enrolment of patients from other countries.
However, patients who took part in the survey said that they are open to using digital tools or remote options to reduce the need for travel. They also highlighted the need for clearer, standard processes and better planning to translate and adapt study materials.
More information:
Recommendations are available from Enpr-EMA on clinical trial preparedness, for sponsors, principal investigators and triallists involved in paediatric clinical trials:
‘Preparedness’ is the structured assessment of contributing factors that enable the smooth conduct of clinical trials in a timely manner.
The recommendations cover the following areas:
Enpr-EMA published the recommendations in August 2020. The final recommendations take account of feedback from stakeholders received via a public consultation in 2019. The recommendations of the working group were published in Archives of Disease in Childhood in 2021: Recommendations by Enpr-EMA on preparedness of clinical trials.
Involving young people and family members in clinical research has many benefits, including greater understanding of young people's perspectives and improvements in study design and the quality of clinical research.
Enpr-EMA has established young person advisory groups (YPAG) within the Enpr-EMA members. These members set up the European network of young people advisory groups (eYPAGnet), which aims to become the single point of contact for all YPAGs in Europe.
In 2017, in collaboration with Enpr-EMA, EMA has agreed on principles for involving patients and consumers below 18 years of age in the activities of its scientific committees and working parties:
This follows a 2014 Enpr-EMA survey with EMA's Paediatric Committee (PDCO) on the potential involvement of young people and families in PDCO activities and strengthening the participation of members representing patients' organisations in the Committee. For full details, see:
Enpr-EMA also surveyed its paediatric research networks on the involvement of young people and family members in 2012. The survey results indicated that, although more than half of the networks that responded actively involve young people or families, only three networks out of thirty-nine had developed strategies or guidelines for the involvement of young people and families. For these documents, see:
As of 2017, Enpr-EMA and the European Network of Research Ethics Committees (EUREC) are exploring ways of collaboration.
As a first step, Enpr-EMA and EUREC will collect ideas for collaboration and collect a survey on needs and expectations among their members.
The role of research nurses in coordinating clinical trials involving children has become more important in recent years, due to increasing complexities of clinical trial design.
Enpr-EMA is exploring ways to facilitate connections between paediatric research nurse networks and groups in Europe. As a first step, it has compiled a list of networks and groups via the Enpr-EMA network:
Enpr-EMA has also carried out a survey with research nurses to investigate the training needs of research nurses involved in paediatric trials across Europe and to compare roles across specialties and countries. The survey results were published in 2017:
Consent requirements are not harmonised in Europe and vary according to national laws and regulations. These discrepancies can present challenges for paediatric clinical trials, especially as many are conducted as multinational trials.
To provide a comprehensive multinational overview on informed consent and assent requirements of paediatric clinical trials across Europe, an Enpr-EMA working group has collated the legal requirements in EU Member States, plus Iceland and Norway:
Enpr-EMA updates this document as necessary.
For more information on the working group's findings, see:
The working group has also published recommendations regarding the contents of the various subject elements of consent / assent forms for each paediatric age group, to be considered when designing these documents:
For more information on the working group's findings, see:
Enpr-EMA aims to facilitate interactions between medicine developers and paediatric research networks on issues related to paediatric medicine development.
In 2018, Enpr-EMA published Enpr-EMA Working group on public-private partnership: Network consultation recommendation outlining the recommended model for consulting paediatric research networks, particularly on developing and conducting paediatric investigation plans.
This guidance was informed by a 2015 Enpr-EMA survey with industry representatives and paediatric clinical trial networks on how they engage with one another. Enpr-EMA published the survey results in 2016:
Enpr-EMA also facilitates interactions between SMEs and academic investigators in paediatric-medicine research, by providing them information on networking and partnership opportunities.
Enpr-EMA works with international partners specialising in the regulation of medicines for children, including with the:
Enpr-EMA has set up a working group to explore further collaborative opportunities with international regulators and paediatric research networks.
Enpr-EMA contributes to important public consultations related to paediatric medicine research in Europe. It publishes some of the comments it submits to public consultations on this website.
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in May 2026.
2 October 2025
Section on 'Cross-border clinical trials' added