5/6/20
PROTOCOLO DE SEGURIDAD Y PREVENCIÓN
ACTIVIDADES CIENTIFICO-TÉCNICAS DE LOS PROFESIONALES DE LA INDUSTRIA FARMACEUTICA Y DE TECNOLOGÍAS SANITARIAS.
Comunicación de los centros para la vuelta a la monitorización de ensayos clínicos.
4/5/20
The latest revision (v3) of the Guidance on how to manage clinical trials during the COVID-19 pandemic was published on 28 April. This version contains key changes based also on the feedback from different stakeholders’ groups (patients’ organisations, academia and industry) before and during the drafting process.
In order to provide your Organisation with an overview of the most important elements of this Guidance and the possibility to identify aspects for additional clarification, a webinar will be organised jointly by the European Commission, the European Medicines Agency and the Clinical Trials Facilitation and Coordination Group of HMA with the participation of the drafting team members on 15 May 15.00-17.00.
You will find more information about the webinar by clicking here.
The number of participants will have to be limited for technical reasons and thus early registration is advisedby sending a message to: SANTE-PHARMACEUTICALS-B4@ec.europa.eu using “Registration to the webinar on the Guidance on clinical trials during COVID-19” in the subject line.
The link to allow access to the webex conference will be shared with participants later in May. In order to make the information available for broader public, the webex will be recorded and made public on the EMA and Commission website: EUTube.
28/4/2020
GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC (Version 3)
09/04/20
EMA published the mandate of its COVID-19 EMA pandemic Task Force (COVID-ETF) . The Task Force is helping EU Member States and the European Commission to take quick and coordinated regulatory action on the development, authorisation and safety monitoring of treatments and vaccines intended for the treatment and prevention of COVID-19. For more information, see:
The International Coalition of Medicines Regulatory Authorities published the report summarising the second global regulatory workshop on COVID-19 medicine development held on Thursday 2 April. The report stresses the need for robust evidence to show which potential treatments work. EMA co-chaired the meeting. For more information, see:
08/04/20
Medidas excepcionales aplicables a los ensayos clínicos para gestionar los problemas derivados de la emergencia por COVID-19.
07/04/20
EMA Press Release
“New measures to support availability of medicines used in the COVID-19 pandemic”: Link.
06/04/20
European Commission
Commission postpones application of the Medical Devices Regulation to prioritise the fight against coronavirus
06/04/20
Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials
01/04/20
EMA has published its Regulatory Science Strategy to 2025 today. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic acceleration of the pace of innovation in recent years and the need for regulators to be ready to support the development of increasingly complex human and veterinary medicines that combine different technologies. The ongoing COVID-19 pandemic underlines the need for rapid and close engagement of all stakeholders and partners involved in the development and supervision of medicines in the European Union and globally, which is one of the fundamental principles of this strategy. The learnings from the handling of this public health crisis will be incorporated so that we can adapt our process in real-time, where needed.
The strategy sets out key areas where new or enhanced engagement of the European medicines regulatory network is essential and where advances in regulatory science are necessary.
The document identifies strategic goals for such engagement for human and veterinary medicines and proposes core recommendations and underlying actions to support these.
For the press release and related content, please click here.
31/03/20
Ministerio de Sanidad
INFORMACIÓN CIENTÍFICA-TÉCNICA: Enfermedad por coronavirus, COVID-19
30/03/20
European Commission
Directorate-General for Health and Food Safety
AECIC: Review of the Guidance (v2) for sponsors on how to manage clinical trial during the COVID-19 pandemic
The new version of the Guidance was published this Friday (March 27). A few topics have already been flagged for further clarifications in the next version (v3), which is planned to be published before Easter.
The aim of the harmonised EU-level guidance is to provide sponsors/CROs with recommendations on how to mitigate the negative effects of COVID19 on trial management.
Due to time constraints related to the need for timely publication of the first 2 versions of the guidance, it was not possible to ask for your involvement. Now, we would like to ask for your opinion on the current draft and suggestions for its improvement (attached and here): https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
Thank you for letting us know:
– which sections you found to be the most helpful;
– where you would need further clarification (with indicating the section, problem (concrete examples are welcome) and possible suggestions);
– any additional related comments, views.
Since the drafting and publication is time-sensitive, we would like to ask for your feed-back before Wednesday evening (April 1) if possible. For the same reason, I include EMA and CTFG colleagues in the drafting team in cc on this message, thank you for keeping them as addressees on your responses.
26/03/20
Today (25 March 2020), the Commission announced that work on a proposal to postpone the date of application for the Medical Device Regulation (MDR) for one year is ongoing. The decision was reached with patient health and safety as a guiding principle.vor 3 Stunden
https://ec.europa.eu/health/sites/health/files/docs/20200325_news_md_en.pdf
26/03/20
Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials
25/03/20
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EMA Communications: https://www.eucrof.eu/ema-communications
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Regulations: https://www.eucrof.eu/regulations
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Coronavirus – Information: https://www.eucrof.eu/coronavirus-information
23/03/20
Guidance Clinical Trials COVID-19
20/03/20
The EMA’s Human Medicines Committee (CHMP) has published a statement urging the EU research community to prioritise large randomised controlled studies because they are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments of CIVID-19. The statement promotes a harmonised approach to data collection and a robust methodology for COVID-19 clinical trials across the EU to make best use of the available supply of investigational agents. It emphasises the need to include all EU countries in these trials.
Please see further details in the enclosed link.
19/03/20
Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments
19/03/20
Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials
The U.S. Food and Drug Administration today, 18 March 2020, issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.
Herewith the link: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-guidance-conducting-clinical-trials
17/03/20
La AEMPS está trabajando en diferentes vías de investigación clínica para el tratamiento del COVID-19
Categoría: La AEMPS
Referencia: AEMPS, 9/2020
Han comenzado dos ensayos con remdesivir para pacientes con enfermedad moderada o grave en tres centros sanitarios, a los que se les sumarán otros cinco en los próximos días.
Se ha iniciado otro ensayo clínico, promovido por la Fundación FLS, enfocado a casos confirmados no graves de COVID-19 y a quimioprofilaxis de contactos de riesgo
Está finalizándose la aprobación de un protocolo de ensayo clínico de la OMS para extraer información relevante de la práctica que se está llevando a cabo en centros sanitarios
LA AEMPS se pone a la disposición de promotores e investigadores para ofrecerles asesoría científica y reguladora con el fin de acelerar la investigación en este área
Para acceder a la información pulse sobre la dirección, o bien copie y pegue ésta en su navegador:
https://www.aemps.gob.es/informa/la-aemps-esta-trabajando-en-diferentes-vias-de-investigacion-clinica-para-el-tratamiento-del-covid-19/
17/03/20
Medidas excepcionales aplicables a los ensayos clínicos para gestionar los problemas derivados de la emergencia por COVID-19
Categoría: MEDICAMENTOS DE USO HUMANO
Referencia: MUH, 4/2020
· Estas medidas están destinadas a garantizar la actividad de ensayo, la seguridad y bienestar del paciente y la trazabilidad de las acciones implementadas
Su aplicación no requiere de aprobación por parte de la AEMPS o el CEIm, pero deberán comunicarse una vez la crisis sanitaria del COVID-19 se dé por finalizada.
Para acceder a la información pulse sobre la dirección, o bien copie y pegue ésta en su navegador:
https://www.aemps.gob.es/informa/notasinformativas/medicamentosusohumano-3/2020-medicamentosusohumano-3/medidas-excepcionales-aplicables-a-los-ensayos-clinicos-para-gestionar-los-problemas-derivados-de-la-emergencia-por-covid-19/
16/03/20
EMA provides full fee waivers for scientific advice applications from developers of potential therapeutics (to treat the disease) or vaccines (to prevent the disease) against the novel coronavirus disease (COVID-19).
Developers of potential therapeutics or vaccines against COVID-19 are invited to contact the Agency as soon as possible with information about their proposed development, by emailing 2019-ncov@ema.europa.eu. In a first round of discussions, EMA can provide preliminary informal comments and feedback on the development. This will then allow the Agency to identify the products which are mature enough to benefit from fast-track scientific advice, to guarantee best use of this tool.
In the context of the COVID-19 pandemic, with this fast-track scientific advice, the Agency can give developers prompt guidance and direction on the best methods and study designs to generate robust information on how well a medicine or vaccine works and how safe it is.
Since the beginning of the outbreak, the Agency has organised teleconferences with several developers of potential medicines and vaccines against COVID-19. Member States are kept updated on these activities. EMA is also working closely with international regulatory authorities.
EMA is actively supporting the World Health Organization’s (WHO) activities on the prioritisation and analysis of available evidence. Most potential therapeutics initially identified in this context are repurposed agents (i.e. medicinal products already authorised for another purpose) or investigational agents that are or will be investigated for treatment and in some cases for prophylaxis against the disease. EMA’s priority is to accelerate the approval of safe and effective therapeutic candidates to treat people infected by the virus as soon as possible.
Vaccine development is still at an early stage. There are no existing vaccines that could be repurposed to work against the new virus. Timelines for vaccine development are difficult to predict at this point, but it is currently estimated that the first clinical trials will not start before April/May 2020. This means that it will take several months before candidate vaccines are ready for larger clinical studies. Once there is sufficient information available, EMA is ready to assess any applications for marketing authorisation within the shortest possible timelines.
EMA has a range of support measures that can help to facilitate and speed up the development of medicines, which in addition to fast-track scientific advice includes the PRIME scheme, the accelerated assessment, and conditional marketing authorisation procedures. Adequate demonstration of quality, safety and efficacy is expected in order to support the authorisation of medicinal products duly taking into account the context of a global health emergency.
This information and more related content are published here.
13/03/20
Covid-19: medidas excepcionales de la AEMPS aplicables a los ensayos clínicos
La AEMPS está trabajando en un documento con medidas excepcionales aplicables a los ensayos clínicos para gestionar los problemas que se han planteado a la Agencia por el Covid-19. En este contexto, se considera relevante salvaguardar las actividades del ensayo en la medida de lo posible, con la finalidad de proteger la seguridad y bienestar de los pacientes y la fiabilidad de los resultados obtenidos en el mismo. El documento establecerá una serie de recomendaciones sobre aspectos como: i) visitas presenciales programadas de los pacientes; ii) acceso al tratamiento del ensayo; iii) visitas de monitorización; y iv) transferencia de pacientes de unos centros a otros. Este documento será publicado próximamente y se informará de ello. Desde la AEMPS también han confirmado la posibilidad de enviar por correo electrónico en formato pdf toda la documentación relativa al mantenimiento de los estudios posautorización de tipo observacional actualmente en marcha. Este envío sustituirá al envío por correo ordinario.