Open letters

The European Medicines Agency (EMA) publishes open letters, usually in response to contributions and feedback from stakeholders.

Joint response from European Medicines Regulatory Network to letter from Health Action International and other health groups on missing clinical trial results in CTIS

Joint response from European Medicines Regulatory Network to letter from Health Action International and other health groups on missing clinical trial results in CTIS

Replies to open letters from Members of the European Parliament concerning the marketing authorisations of mRNA COVID-19 vaccines

Follow-up reply to Members of the European Parliament regarding mRNA COVID-19 vaccines

Reply to Members of the European Parliament regarding mRNA COVID-19 vaccines

Reply in follow up to the COVI exchange of views on 27 March 2023

EMA reply in follow up to the COVI exchange of views on 27 March 2023

Reference Number: EMA/150586/2023

Reply to open letter from Members of the European Parliament's letter on psychedelic-assisted therapies

EMA reply to a letter from Members of the European Parliament, Mr Agius Saliba, Ms Ries, Mr Duda, Mr Biedroń, Ms Cerdas and Ms Metz concerning psychedelic-assisted therapies

Reply to open letter from Members of the European Parliament concerning COVID-19 vaccines

EMA reply to a letter from Members of the European Parliament, Ms M. Rivasi, Mr P. Pedicini and Ms T. Metz concerning COVID-19 vaccines

Reply to open letter from ‘Doctors for COVID ethics’ concerning COVID-19 vaccines

Reply to open letter to ‘Doctors for COVID ethics’ concerning COVID-19 vaccines

Reference Number: EMA/292405/2021

Reply to open letter concerning COVID-19 vaccines

Reply to open letter concerning vaccines for COVID-19

Reference Number: EMA/140520/2021

Letter from the chairs of EMA's Management Board to Guido Rasi at the end of his term as EMA's Executive Director

Letter from the chairs of EMA's Management Board to Guido Rasi at the end of his term as EMA's Executive Director

Reference Number: EMA/561503/2020

Reply to open letter concerning the transparency and evaluation of vaccines for COVID-19

Reply to open letter concerning the transparency and evaluation of vaccines for COVID-19

Reference Number: EMA/565800/2020

Response to the European Ombudsman concerning transparency and independence of EMA's work in supporting the development and evaluation of COVID-19 medicines

Reply to the European Ombudsman’s letter concerning transparency and independence of the work of the European Medicines Agency in supporting the development and evaluation of COVID-19 medicines

Response to the Institute for Quality and Efficiency in Health Care (IQWiG) and the Cochrane Collaboration on transparency of COVID-19-related activities

European Medicines Agency response to IQWIG on transparency of COVID-19 related activities

Reference Number: EMA/280976/2020 Summary:

European Medicines Agency response to IQWIG on transparency of COVID-19 related activities

Response to European Ombudsman regarding pre-submission activities

European Medicines Agency second response to European Ombudsman regarding pre-submission activities

Reference Number: EMA/627113/2019

European Medicines Agency first response to European Ombudsman regarding pre-submission activities

Reference Number: EMA/566402/2017

Response to Nordic Cochrane Centre on safety review of human papillomavirus vaccines

EMA response to Nordic Cochrane letter on human papillomavirus (HPV) vaccines - Conflict of interest issues of Executive Director

EMA response to Nordic Cochrane letter on EMA response to Nordic Cochrane letter on human papillomavirus (HPV) vaccines - Maladministration

Clarifying the adaptive pathways concept

EMA response to a letter from a group of scientists clarifying the concept of adaptive pathways

Response to European Ombudsman explaining redaction rules

Letter to European Ombudsman

Summary:

Agency responds to European Ombudsman

Response to European Ombudsman on clinical trial data transparency

European Medicines Agency letter to European Ombudsman regarding proactive publication of and access to clinical trial data

Letter to Member of European Parliament requesting correction

Letter from the European Medicines Agency to Ms M Rivasi regarding Dr Xavier Kurz

Reference Number: EMA/858830/2011

Response to British Medical Journal editorial on the new Agency

An open letter to the Editor of the British Medical Journal

Reference Number: EMEA-D-MH-34849-1998