9 January 2013
EMA/14946/2013
Patient Health Protection
European Medicines Agency process for engaging in
external regulatory sciences and process improvement
research activities for public and animal health
Table of contents
1. Executive summary ................................................................................. 2
2. Introduction ............................................................................................ 2
2.1. Current involvement of the agency in research activities ........................................... 3
3. Scope....................................................................................................... 4
4. Objectives ............................................................................................... 4
5. Possible roles and level of involvement of EMA ....................................... 4
5.1. Coordinator of a research project ........................................................................... 5
5.2. Participant in research activities ............................................................................. 5
5.3. Advisory role (in externally led projects) ................................................................ 5
6. Resources and financial implications ....................................................... 5
7. Area of research ...................................................................................... 6
7.1. Applicability and relevance to the agency’s work ...................................................... 6
7.2. Added value of contribution from regulators to the project ........................................ 6
7.3. Continuation and strengthening inter-institutional and/or international collaborations ... 7
8. Other points to consider .......................................................................... 7
8.1. Quality and soundness of the research proposal ....................................................... 7
8.2. Confidentiality, access to data and disclosure of results ............................................. 7
8.3. Conflicts of interest............................................................................................... 8
9. Procedure for deciding on EMA involvement ............................................ 9
10. Framework for collaboration agreements ............................................ 11
11. EMA research inventory ....................................................................... 11
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1. Executive summary
This document sets out an agency-wide approach to the agency’s engagement in research activities
notably in regulatory sciences to support regulatory decision-making and to improve business
processes for the benefit of public and animal health. To this end it provides a framework for dealing
with requests and/or proposals for participation in research projects, use of resources, potential
conflicts as well as for coordination, governance and tracking of research activities. It discusses a
number of points to consider when deciding on the agency’s participation in research, including the
possibility of leveraging external expertise, capacities, resources and funding, the potential for conflicts
of interest that may arise from the agency’s involvement and the importance of ensuring that
appropriate project management is in place, in line with relevant EMA procedures. It also defines
possible roles and levels of active involvement to increase clarity about potential implications for the
agency and its staff. The document furthermore proposes a centralised process channelling all requests
and/or proposals for research activities through senior agency management, thus ensuring that all
research undertaken will significantly contribute to fostering scientific excellence in the evaluation and
supervision of medicines, for the benefit of public and animal health. Finally, it is proposed that
prioritisation of participation in major research activities will be integrated into the cross agency
project prioritisation process when this process is routinely operating to a timeframe compatible with
competitive calls for research bids. Until the cross agency process is operating to that time-frame, it is
proposed to maintain a stand-alone inventory of EMA participation in external research projects.
2. Introduction
In order to comply with the agency’s mission to foster scientific excellence in the evaluation and
supervision of medicines, for the benefit of public and animal health it is important for the agency to be
aware of the latest scientific knowledge and methodologies and to actively support science in relevant
areas, as defined in the agency’s Road Map 2010-2015 1 and the related ‘From vision to reality’
document 2. In particular, new challenges arise from new and emerging sciences and the increasing
drug development productivity gap. Given the agency’s central role and primary responsibility to
promote and protect public and animal health, and to support its business processes in the evaluation
and supervision of medicines, it is essential for EMA to further evolve from a passive bystander to
having an active role in important scientific progress, in particular with a view to developing the
regulatory framework. Other regulatory authorities including the U.S. Food and Drug Administration
(FDA), Health Canada and most recently the Japanese Pharmaceuticals and Medical Devices Agency
(PMDA) 3 have integrated regulatory science 4 in their core activities. In this way, participation in
regulatory sciences will support regulatory decision-making and will improve business processes for the
benefit of public and animal health.
The current document supersedes the EMA policy on projects to assess and improve the methodology
and outcomes of EMA’s scientific activities (Doc.Ref. EMEA/438223/2008) further elaborating on key
issues, such as conflicts of interest and defined roles and responsibilities of EMA. It also takes into
1
Road Map to 2015: The European Medicines Agency’s contribution to science, medicines and health
(http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000292.jsp&mid=WC0b01ac05
800293a4).
2
Implementing the European Medicines Agency’s Roadmap to 2015: The Agency's contribution to Science,
Medicines, Health - “From Vision to Reality”
(http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/10/WC500115960.pdf).
3
PMDA International Vision – PMDA EPOCH Toward 2020
(http://www.pmda.go.jp/english/international/pmda_international_vision.html).
4
Regulatory science is defined as a range of scientific disciplines that are applied to the quality, safety and efficacy
assessment of medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine. It
encompasses basic and applied medicinal science and social sciences, and contributes to the development of regulatory
standards and tools.
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account lessons learnt from past and ongoing collaborations and the need to make best use of the
agency’s limited resources.
2.1. Current involvement of the agency in research activities
In recent years, the agency has intensified its interactions with stakeholders beyond the regulatory
network, including a dialogue with pharmaceutical industry as well as increasing the involvement of
patients, consumers and healthcare professionals in the agency’s work. The agency has also made the
effort to engage to a greater extent with academia, learned societies and research groups, as reflected
– for example - in the establishment of the European Network of Centres for Pharmacoepidemiology
and Pharmacovigilance (ENCePP) and the European Network of Paediatric Research at the European
Medicines Agency (Enpr-EMA). As a result of this engagement and the importance placed on regulatory
sciences to support its business processes, the agency is facing an increasing number of requests and
opportunities to contribute to research programmes.
The Agency’s involvement in research to date includes:
•
providing a forum for discussion and debate in the Committees, Working Parties
•
organising scientific workshops with participation of various stakeholders (e.g. the transatlantic
workshop on drug-induced progressive multifocal leukoencephalopathy) 5.
•
participating in scientific conferences
•
providing experts to steering committees of research projects and boards of learned societies
•
establishing and supporting networks of excellence e.g. in paediatric (Enpr-EMA) and in
pharmacoepidemiology (ENCePP) research
•
engaging in research initiatives of other European or international health bodies [including the
European Centre for Disease Prevention and Control (ECDC), the World Health Organisation
(WHO), FDA, etc.]
•
performing literature reviews and database studies (spontaneous reports and healthcare) in
relation to medicines evaluation
•
analysing in-house data (e.g. across products and/or indications) and publishing the results to
contribute to better drug development and/or further improve the evaluation and supervision of
medicines. In-house or internal data refers to historical data stored in internal databases, for
example on scientific opinions/recommendations of the various EMA committees and working
parties, such as CHMP, PDCO, COMP, Scientific Advice, etc. While there may be synergies with the
current EMA endeavour to analyse company raw data, the focus of this latter activity is completely
different, as detailed in the document Raw Data Analysis EMA/14946/2013.
•
advising on policies 6 and identifying research priorities for public (or part public) funding
programmes [European Commission (EC) Directorate General for Research and its framework
programme, as well as contributing to the development of the Innovative Medicines Initiative (IMI)
Strategic Research Agenda]
•
launching in-house initiatives on topics of interest in relation to regulatory science, e.g. Committee
for Medicinal Products for Human Use (CHMP) Benefit:Risk project
5
Further detail is available on the EMA website at
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2011/02/event_detail_000399.jsp&murl=
menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c3.
6
E.g. Art 4(2)(b) of Orphan Reg 141/2000
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•
coordinating or actively participating in externally funded and/or led projects
•
providing for visiting academics as detached national experts.
3. Scope
This process mainly addresses research collaborations (focussing on human or veterinary medicines)
involving contribution from or led by external parties. Major in-house projects (potentially including
involvement from the European Medicines Regulatory Network, the agency’s Scientific Committees and
Working Parties) should also follow relevant parts of this process. The process excludes projects
addressed in the agency’s policy on training and career development (Doc.Ref. EMA/68023/2011) and
which have been approved in accordance with the staff Regulations Part I, Title II, Art 12.
4. Objectives
This process aims to
•
stratify roles and levels of involvement of EMA in research activities,
•
provide guidance on if and when participation in research constitutes a conflict of interest for EMA,
including accepting funding for the agency’s contribution
•
develop a harmonised and centrally coordinated approach to oversee and manage EMA research
related work, support and advisory activities, in time feeding in to the cross-agency project
prioritisation process
•
identify other relevant points to consider in order to provide a common framework and increase
consistency when prioritising and making decisions on the agency’s involvement in research.
5. Possible roles and level of involvement of EMA
The agency’s level of involvement in a project may range from being the driving force behind an
initiative to taking the role of an observer 7. For the purpose of this process, the role of observer is
considered non-participation and is therefore excluded from this process. EMA may nevertheless
indirectly support a research project e.g. by facilitating contacts with the European Medicines Network
or supporting exchange of information, including feedback, at the level of one of its Scientific
Committees or Working Parties.
When considering participation in a research project, the most suitable level of EMA involvement
should be identified taking into account the agency’s mission and the expected benefits for the agency,
resource constraints and potential (actual and perceived) conflicts of interest. It is also important to
clarify the expectations from the involvement of EMA vis-à-vis what the agency realistically will or can
contribute.
The following roles and responsibilities are distinguished:
•
Coordinator of a research project
•
Participant in research activities
•
Advisory role
7
For the purpose of this document, observer status is understood as being invited as an observer to a project Steering
Group or Advisory Board to observe proceedings/discussions in a passive way. The resource implications are negligible as
no contributions to the project are expected (the observer would normally provide feedback to EMA “for information only”).
One example is the EMA observer status on the industry Progressive Multifocal Leukoencephalopathy (PML) consortium.
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5.1. Coordinator of a research project
EMA might decide to lead on a project proposal and take the role of the overall scientific project
coordinator, whether or not in response to a call for proposals of a funding initiative. For externally
funded projects the role of project coordinator is normally defined in the project and grant agreements,
which stipulate the legal, financial and managerial responsibilities. Collaborations that do not receive
dedicated external grants may require setting up individual research agreements defining rights and
obligations of participants and addressing issues in relation to confidentiality, access to data and
conflicts of interest (see also chapters 8.2. and 8.3. ).
Coordination of research projects usually requires substantial resources and depending on the
timelines of the project, a commitment as coordinator might last several years.
The coordinator is also a participant to the project (see 5.2. ).
5.2. Participant in research activities
Being a participant in a project means being a party to a research consortium, contributing towards the
project objectives and having rights and obligations under the terms of the respective project and
grant agreement, as applicable. The actual contribution, budget, timelines and other conditions of
participation are laid down in the afore-mentioned agreements or annexes thereof and may vary
substantially between different projects. When being a participant in a project, EMA may receive
funding for its contribution provided that such remuneration does not constitute a conflict of interest.
(see also chapter 6. and 8.3. ).
5.3. Advisory role (in externally led projects)
EMA might be invited to join an advisory board of a project, reviewing the research agenda and project
progress and providing regulatory expert advice and guidance on the future direction. Potential
conflicts of interest should be considered in line with chapter 8.3. From a resource perspective,
membership of an advisory board may consist of reviewing results and other project documents and
participation in meetings. The required resources and time commitment are normally limited.
6. Resources and financial implications
Active participation in research programmes can potentially be resource-intensive and might involve a
commitment over several years. The exact conditions of the participation - including resource
implications and duration of contribution as well as any funding to the EMA - should be clarified before
the agency commits to lead or participate in a project. Due consideration should also be given to the
internal EMA management of the research project and resource constraints should be considered to
ensure that the participation is sustainable whilst maintaining the agency’s core activities. It is noted
that very long-term commitments can be difficult to sustain due to the potential for (unforeseen)
changes in the EMA budget.
In line with a Heads of Unit (HoU) decision from January 2010, the agency should explore the
possibility of obtaining funding for the project and its contribution. Potential conflicts arising from such
funding should be considered as described in section 8.3.
When deciding on an EMA research activity, the potential benefits of the project for the agency should
be weighed against the costs arising from the activity. Participation in collaborative projects with
multiple stakeholders in health care will enable the agency to leverage external expertise,
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competencies, resources and funding. In this context, serious consideration should be given to the
question to which extent the project overlaps with the agency’s legal role and responsibilities.
Research activities will be progressed in line with the priority determination and resource allocation
that takes place as part of the Agency’s normal planning cycle. If it is decided that the estimated costs
and resource requirements in relation to a proposed research activity are too high and not sustainable,
a reduced involvement could be considered, e.g. contribution as an advisory board member rather
than as an actual participant.
7. Area of research
The agency’s scientific activities will focus on certain areas of research taking into account
•
the applicability and relevance to the agency’s work, and in particular to that of its Committees,
•
the added value of contribution from regulators to the project, and
•
the need for continuing and strengthening inter-institutional and international collaborations e.g.
WHO, ECDC, FDA, EC.
7.1. Applicability and relevance to the agency’s work
Areas of research to which the agency might contribute should be closely related to the agency’s role
and responsibilities as well as to key strategic areas as defined in the current Road Map - and further
detailed in “From Vision to Reality” - and Work Programme 8.
The agency’s Road Map to 2015 defines three strategic areas:
•
Addressing public-health needs,
•
Facilitating access to medicines, and
•
Optimising the safe and rational use of medicines
The agency might support research that is expected to help promote public health, to improve how the
agency and its Committees evaluates and supervises medicines and to have an impact on one or
several of the strategic areas. It is particularly important to foresee and subsequently measure the
impact of the research in the evaluation and supervision of medicines, for the benefit of public and
animal health.
Examples include investigations into novel methodologies of quantifying benefits and risks of
medicines, or into more effective ways of communicating medicines’ benefits and risks to the public.
EMA will not get involved in activities that are outside its legal role or its mission statement.
7.2. Added value of contribution from regulators to the project
The support of projects will also depend on the added value of contributions from regulators. Projects
that may benefit from the involvement of regulatory expertise include – inter alia - those addressing
questions in areas of emerging and innovative sciences - where the regulatory framework requires
constant development, as well as the identification of research priorities in unmet medical needs (e.g,
antibiotics, rare diseases, pregnant women, paediatrics) and research into the development of
methodologies in regulatory sciences.
8
EMA Work Programmes
(http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000242.jsp&murl=m
enus/about_us/about_us.jsp&mid=WC0b01ac058002933c).
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Some projects may already collaborate with national competent authorities thereby covering the need
for regulatory input. However, in some cases it might still be important for the agency to be involved,
e.g. to uphold community interests.
Furthermore, active involvement from EMA in regulatory sciences may be critical to support their
relevance to regulatory decision-making and to ensuring they improve business processes for the
benefit of public and animal health.
7.3. Continuation and strengthening inter-institutional and/or
international collaborations
EMA welcomes collaborations with other organisations. It might be the case that one of our
EU/international partners is working on a research project and requests EMA participation. The degree
of collaboration might range from a purely external advisory role to a full research partnership,
depending on the strategic importance to the EMA, the requested contribution and the available
resources.
8. Other points to consider
Other points to consider for the agency’s involvement in research activities include
•
Quality and soundness of the research proposal,
•
Confidentiality and access to data, and
•
Conflicts of interest.
8.1. Quality and soundness of the research proposal
The basis of every scientific activity should be a project proposal outlining the scope of the research,
the work plan, management structure, resource and budgetary aspects as well as addressing relevant
legal and ethical points. The agency will only contribute to projects of high methodological quality and
conceived in a sound manner suggesting a successful outcome likely to improve the evaluation and
supervision of medicines. Projects should be compliant with applicable legal and ethical obligations and
follow relevant good practices.
Whether or not a project proposal fulfils these requirements will be established by the agency on a
case-by-case basis. To this end the proposal should be reviewed by a multidisciplinary ad-hoc review
group led by the Senior Medical Officer (SMO, see also chapter 9. ). The composition of the review
group might vary (depending on the nature of the research proposal) but should involve no less than
three experts, with relevant expertise drawn from EMA staff members, the agency’s Scientific
Committees, Working Parties, or external experts as appropriate.
8.2. Confidentiality, access to data and disclosure of results
The agency has access to a unique repository of both pre-clinical and clinical data on numerous
medicines which represents an extremely valuable source for drug-related research. The agency will
make available its data as openly as possible whilst ensuring protection of personal data and
commercially confidential information in line with the agency’s Transparency Policy 9, the Policy on
9
At the time of adoption of the strategy the agency had published a draft transparency policy
(http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000187.jsp&mid
=WC0b01ac0580050108).
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Access to Documents 10 and existing confidentiality arrangements with our international regulatory
partners. The need for individual confidentiality agreements allowing sharing of documents and
information for the purpose of the respective research should be considered (see also chapter 10.
‘Framework for collaboration agreements’).
It is expected that all research results will be communicated to external stakeholders in a transparent
way, whether by means of publication in a medical journal or on the agency’s website. In order to
guarantee all published material communicates the results effectively, the project leader should ensure
adequate medical writing expertise is available.
8.3. Conflicts of interest
The agency’s role in the scientific evaluation of medicinal products demands high standards of
professional conduct, integrity and independence in any activity the agency engages in. The potential
for a conflict of interest to arise from a research activity should be established in line with the EMA
Code of Conduct 11, the Decision on rules relating to Articles 11a and 13 of the Staff Regulations
concerning the handling of declared interest of employees of the EMA and the related Implementing
rules relating to Articles 11a and 13 of the Staff Regulations concerning the handling of declared
interests of employees of the European Medicines Agency (EMA/565945/2009).
In this context, participation in research activities may give rise to specific questions and issues that
require careful consideration. Of note, conflicts of interest are related to the role and level of
involvement of the agency and while conflicts may arise from an active contribution, there would
usually be no concern if EMA takes the role of an observer.
Type and scope of research activities
In some cases, the subject of the research itself could create a conflict of interest, e.g. if the research
will lead to the development of a particular medicinal product or research that will only benefit one or
several companies. Furthermore, careful evaluation is required when considering direct involvement in
projects seeking to develop methodologies for drug development, which at a later stage may become
part of a marketing authorisation application, or scientific advice and as such be assessed by the
agency. However, research that is non-competitive in nature and does not overlap with regulatory
decision-making will be less likely to create conflicting interests.
Therefore, study protocols and research agendas should be reviewed for elements that could give rise
to concerns regarding the agency’s impartiality in medicines evaluation, including the motivation for
the research as well as the intended outcome. Hence, the agency may well research a safety concern
pertaining to a specific medicinal product in the interest of public health, but would not contribute
towards the development programme of a particular product or pharmaceutical company outside the
foreseen scientific advice and protocol assistance procedures.
Collaborative research involving participation from industry
For research collaborations involving participation of pharmaceutical companies, all relevant aspects of
the interaction between the agency and industry should be clearly defined, preferably as part of a
written collaboration agreement. In principle, joint research efforts involving contribution from industry
are possible as long as the agency preserves its financial independence throughout the process (see
10
EMA policy on access to documents
(http://www.ema.europa.eu/ema/index.jsp?curl=pages/document_library/document_listing/document_listing_000312.jsp&
mid=WC0b01ac0580022517).
11
The European Medicines Agency Code of Conduct
(http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/wrapper_page.jsp&mid=WC0b01ac0580029338#).
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also explanations above in relation to ‘type and scope of research activities’). The potential for
perceived conflicts of interest resulting from joint EMA-industry publications should be carefully
considered as addressed in the relevant agency policy12. It is never acceptable for the EMA to coauthor with one company; joint EMA-industry publications are only possible if several (minimum of
three) companies co-author the manuscript.
It is however noted that joint activities of regulators and pharmaceutical industry are sensitive and
have the potential to create a negative perception with the general public. Therefore, even in the
absence of established conflicts of interest, the agency should always apply a proactive approach and
communicate in a clear and transparent manner on all relevant activities, and addressing potential
concerns in the perception of the agency’s actions.
Collaborative research involving participation from non-industry parties
While less apparent than in the case of pharmaceutical companies, interaction with Universities, EU or
non-EU National Competent Authorities, other non-industry based institutions, or learned societies may
also require careful consideration as these parties may themselves hold interests (e.g. receipt of
private grants or collaboration with industry) that could be in conflict with the agency’s role and
responsibilities. Appropriate consideration should be given to such interests, if any.
Grants and remuneration of EMA activities
The agency may be involved in (and potentially lead) projects that receive grants from public and
private sources. Further to a HoU decision from January 2010, the agency may decide on a case-bycase basis to accept remuneration for its contribution to the research, provided that the grant is from a
public body (see also chapters 6. and 8.3. ). The agency will usually accept funding from public sources
as these would be considered financial interests that are compatible with the agency’s role and
responsibilities in medicines regulation.
Publications by agency staff
Agency staff may be involved in publications arising from their contribution to research work. This
might include publications alongside authors from pharmaceutical companies taking into account all
other considerations as described above. All publications should be approved by the peer review group
and prepared in line with the Policy on scientific publications by EMEA staff 12 and the Policy on
scientific publication and representation for European Medicines Agency’s scientific committees and
their members 13 and should be consistent with the agency’s general position as well as previous
communications or decisions and be compliant with relevant rules and principles of the agency.
9. Procedure for deciding on EMA involvement
The following procedure should be followed before engaging in any new research activity or extending
existing research work. Of note, a simplified process requiring only endorsement by the HoS/HoU
[steps (a) and (b)] should be applied for ‘minor’ research activities 14, such as those conducted by a
trainee and focussed on internal data mining6. Unless considering a minor research activity, the HoU
12
European Medicines Agency Policy for Scientific Publications by EMEA Staff
(http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/04/WC500089594.pdf).
13
Policy on scientific publication and representation for European Medicines Agency’s scientific committees and their
members (http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500004627.pdf)
There is no precise definition of what constitutes a “minor research activity”. Typically, such activities will involve inhouse data mining, will not require complex statistical analyses and their expected outcome will be directly associated with
EMA process improvements. Minor research activities will frequently be conducted by a trainee or interim member of staff
and be of limited duration. Other examples of minor research activities include preparation of journal publications (max
resource not expected to exceed 0.25 person months a year (1 week)) .
14
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should apply the methodology for project prioritisation as agreed with the Executive Group in 2012 15.
It should also be noted that prioritisation of participation in major research activities will be fully
integrated into the cross agency project prioritisation process when this process is routinely operating
to a timeframe compatible with competitive calls for research bids. When that occurs this process
document will be updated through the EMA Executive Group.
a) Origin of a proposal - Proposals for new projects may come from any EMA staff member, from
any member of a Scientific Committee or Working Party, or from external EMA experts.
Alternatively, individuals or institutions external to the agency may approach EMA suggesting the
initiation of a project or asking for EMA’s collaboration in a project.
b) Endorsement by respective HoS/HoU and preparation of business case - In the first
instance, all proposals and/or enquiries should be discussed with and approved by the respective
Head of Sector (HoS) and, and at the discretion of the HoS, with the respective Head of Unit (HoU).
For all proposals that are not immediately rejected at this stage, the HoS should appoint an EMA
staff member to act as the project leader, which implies intellectual leadership and project
management responsibilities in line with EMA policies on this matter.
The EMA project leader should prepare a business case with the help from the external project
coordinator in the case of requests for EMA participation in external projects. In addition to
summarising the scientific aspects of proposal, the business case should give due consideration to
the involvement of scientific committees, the internal reporting lines and the importance of
appropriate project management in line with relevant EMA policies.
The HoS/HoU should critically review the business case and should ensure that EMA resource
estimates are sound and realistic. Unless considering a minor research activity, the HoU should
apply the methodology for project prioritisation.
c) Scientific review - Once endorsed by the respective HoS/HoU, the business case should be
discussed with the SMO who will review the proposal as regards compatibility of the research with
the agency’s role, the work of its Scientific Committees and the key strategic areas, as well as
regards the quality and soundness of the proposal. To this end the SMO should convene an ad-hoc
review group of no less than three members with relevant expertise drawn from EMA staff
members, the agency’s Scientific Committees, Working Parties, or external experts, as appropriate.
d) Consultation of HCG (incl. Veterinary representative) – Based on the business case and the
outcome of the scientific review, the EMA project leader should prepare a briefing note and present
the proposal to HCG. HCG will review the proposal and reflect on points to consider as outlined in
this document, including the potential for conflicts of interests.
e) Legal and financial review - For collaborative projects and projects receiving funding from
external sources, the EMA project leader should consult the agency’s legal sector. Furthermore, the
agency’s finance and budget sector should be informed about any research activity that is not
considered to be ‘minor’ (see above definition). All concerns, if any, should be satisfactorily
addressed before pursuing the proposal.
f) ED decision – Based on the outcome of the scientific review and the consultation of HCG, the ED
will issue a decision providing for the mandate of the agency’s involvement in the research activity.
The agency should not start or commit to participate in a project unless a positive decision has been
issued by the ED.
15
Project prioritisation: Outcome for 2012 and recommendations for future years EMA/336706/2012
https://docs.eudra.org/webtop/drl/objectId/090142b281d371ce
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Once a decision has been received from the ED, the EMA project leader should ensure that the project
details are captured in the inventory and in the EMA Project Database 16.
10. Framework for collaboration agreements
Research projects that receive grants usually are based on a contractual agreement addressing
financial rules but also other relevant aspects of collaborative research. Collaborations that do not
receive dedicated external funding may require setting up individual research agreements defining
rights and obligations of participants and addressing issues in relation to confidentiality, access to data
and conflicts of interest (see also chapters 8.2. and 8.3. ). To this end, a framework providing for
standard conditions for EMA participation could be developed and annexed to this document.
11. EMA research inventory
A continuously updated inventory of EMA involvement in external research activities is kept by the
Coordination and Networking Section (P-PV-CN) in order to be able to monitor the agency’s current
and past contributions. The inventory will be circulated to all HoS, HoU and the ED for review on a
regular basis.
16
The EMA Projects database can be found at the following location Fmp7://cv028.emea.eu.int/2012+Projects
European Medicines Agency process for engaging in external regulatory sciences and
process improvement research activities for public and animal health
EMA/14946/2013
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