COVID-19 guidance: research and development
The European Medicines Agency (EMA) provides support to medicine developers researching and developing potential COVID-19 medicines. Dedicated guidance, rapid procedures and contact points are available.
EMA encourages developers of potential vaccines or treatments for COVID-19 to contact EMA as soon as possible to discuss their strategy for evidence-generation.
Establishing contact early in the development process is important for ensuring that developers can submit well-prepared applications and make use of the rapid procedures EMA has put in place for COVID-19 treatments and vaccines.
Medicine developers should email their proposals to PHEearlysupport@ema.europa.eu or 2019-ncov@ema.europa.eu.
They should include:
- a description of the candidate product and its development plan,
- a summary of available evidence supporting its potential role in the COVID-19 setting.
Depending on the maturity of development, EMA will set up initial discussions on suitable mechanisms to fast-track development and approval, with priority given to the most relevant proposals.
Rapid procedures, such as scientific advice, early discussions and paediatric investigation plans (PIPs), facilitate the development and timely approval of COVID-19 medicines.
| PROCEDURE | FEATURES |
|---|---|
| Rapid scientific advice |
For more information see Scientific advice and protocol assistance |
| Rapid agreement of paediatric investigation plans (PIPs) and rapid compliance check |
For more information see Paediatric investigation plans and Paediatric requirements for marketing-authorisation applications |
For more information, see:
Since the start of the COVID-19 pandemic, EMA's Committee for Medicinal Products for Human Use (CHMP) has been urging the EU research community to prioritise large randomised controlled clinical studies as these are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential COVID-19 treatments. The CHMP also emphasises the need to include all EU countries in these trials:
In line with the CHMP's statement, members of EMA staff and its scientific committees provided recommendations on concrete actions that stakeholders involved in COVID-19 clinical trials should take to enable the conduct of decision-relevant clinical trials, in an article published on 15 May 2020:
Advice to sponsors of COVID-19 clinical trials in the EU is included in the guidance on clinical trial management during the pandemic:
In addition, as for all medicines intended to target a public health emergency, EMA's Emergency Task Force (ETF) can provide support to clinical trial sponsors with the following aspects of running a clinical trial for COVID-19 medicines:
- Setting up joint multinational clinical trials
- Acting as a sponsor or co-sponsor
- Decisions on what protocol to follow
This is in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123).
Interested clinical trial sponsors should send their proposals to phesupportct@ema.europa.eu.
They should include the study protocol and specify in which Member State(s) they intend to run clinical trials, if already known.
The ETF works closely with EMA’s partner organisations in the EU to support study sponsors and the conduct of larger multinational trials.
These partner organisations include:
- Heads of Medicines Agencies' (HMA) Clinical Trials Coordination Group (CTCG);
- European Commission's Clinical Trials Advisory Group (CTAG);
- European Health Emergency Preparedness and Response Authority (HERA).
For more information, see Scientific advice and protocol assistance: Medicines intended for a disease causing public health emergency.
On 17 July 2020, the European Parliament and the Council of the EU adopted a Regulation on the conduct of clinical trials with treatments and vaccines against COVID-19 containing genetically modified organisms (GMOs).
The regulation aims to speed up the conduct of clinical trials by providing a temporary derogation from the mandatory environmental risk assessment for these substances during the COVID-19 pandemic. However, a COVID-19 vaccine or treatment containing GMOs would require an environmental risk assessment before it could be marketed in the EU.
For information on ongoing COVID-19 clinical trials in the EU, see Treatments and vaccines for COVID-19: Information on ongoing clinical trials in the EU.
EMA is encouraging collaboration between researchers on high-quality, multi-centre observational studies in the context of COVID-19, and transparency about study protocols and results.
High-quality observational research of real-world data can complement the results of randomised clinical trials in providing evidence on the safety and effectiveness of vaccines and treatments for COVID-19. Such research is also critical for understanding how exposure to certain medicines can affect the risk or the severity of COVID-19.
Researchers should adhere to existing guidelines on the appropriate design and conduct of pharmacoepidemiological studies in order to generate reliable and reproducible evidence, including the Guide on methodological standards in pharmacoepidemiology developed by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).
The foreword to revision 8 of this guide, released in July 2020, highlights the chapters that are particularly relevant to the COVID-19 pandemic and examples of good practice.
To facilitate collaboration between researchers and to help improve the size and methodological rigour of studies, ENCePP has set up a dedicated COVID-19 response group. For more information on the group's activities, see its mandate on the ENCePP website.
In addition, recommendations on conducting high-quality research during the pandemic are available in an article published by EMA staff and EU researchers on 5 May 2020:
EMA and ENCePP are encouraging researchers to register their pharmacoepidemiological studies (and make study protocols and reports public) in the European Union electronic register of post-authorisation studies (EU PAS Register). They should include ‘COVID-19’ in the study title to allow easy retrieval of their studies.
A selection of European Pharmacopoeia (Ph. Eur.) quality standards and accompanying guidance for vaccines and antivirals is currently available free of charge on the website of the European Directorate for the Quality of Medicines & Healthcare (EDQM) of the Council of Europe:
- EDQM: Initiatives in the context of COVID-19 vaccines and therapies
- EDQM: Pharmacopoeial texts for vaccine developers
Specific guidance is also available from EDQM on analytical strategy options for the development of COVID-19 viral vector-based vaccines. This aims to fill a gap in the guidance available on quality for these new technologies:
Medicine developers should also follow the relevant scientific guidelines and other types of guidance on quality-related requirements applicable in the EU. Click on the categories below to find links to these guidelines on this website.
Joint procedural information is available from EMA and the United States Food and Drug Administration (FDA) for medicine developers planning to submit a paediatric investigation plan (PIP) to EMA and an initial paediatric study plan (iPSP) to the FDA for a COVID-19 vaccine or treatment:
The joint document aims to make it easier for developers to submit paediatric development plans simultaneously to the regulators, to help speed up the development and approval of COVID-19 treatments and vaccines.
EMA and the FDA are encouraging medicine developers to submit PIPs and iPSPs early.
EMA and the FDA published the joint document on 2 June 2020.