Medicinal products for human use
Public consultation on the delegated act on post-authorisation efficacy studies
Period of consultation
From 28 November 2012 to 18 February 2013.
Contributions to and results of the consultation
A summary of the responses is available here.
Below are the public responses to the above-mentioned public consultation:
- AESGP – Association of the European Self-Medication Industry
- BPI – German Pharmaceutical Industry Association
- EFPIA – European Federation of Pharmaceutical Industries and Associations
- EUCOPE – European Confederation of Pharmaceutical Entrepreneurs
- LEEM – Association of pharmaceutical industry in France
- PPTA – Plasma Protein Therapeutics Association
- Vaccines Europe
- AEMPS – Spanish Agency of Medicines and Medical Devices
- Arzenimittelkommission der deutschen Ärzteschaft – Drug Commission of the German Medical Association
- CBG-MEB – Dutch Medicines Evaluation Board (the Netherlands)
- EMA – European Medicines Agency
- EUnetHTA – European Network for Health Technology Assessment
- France – Secretariat General des Affaires Européennes
- HAS - La Haute Autorité de Santé (France)
- IQWIG – Institute for Quality and Efficency in Health Care (Germany)
- MHRA – Medicines and Healthcare products Regulatory Agency (UK)
- MPA – Swedish Medicinal Product Agency
- NICE – National Institute for Health and Clincial Excellence (UK)
- RIZIV-INAMI (Belgium)
Academia & Healthcare professionals
- ENCEPP – European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
- ESCAMP – European Scientific Cooperative on Anthroposophic Medicinal Products
- ESC - European Society of Cardiology
- PGEU – Pharmaceutical Group of the European Union
- Van Staa, London School of Hygiene & Tropical Medicine
Other stakeholders and individuals
- AEFI – Spanish Association of Pharmacists in Industry
- EUCROF - European CRO Federation
- Kosim, Marzena, MPharm. :  - 
All citizens and organisations (public and private) are invited to contribute.
Objective of the consultation
Post-authorisation efficacy studies are studies which are undertaken after a medicine has been authorised with the purpose of providing more information on the efficacy of the product within the authorised indications.
Those studies are not an entirely new feature, already now post-authorisation efficacy studies may be conducted. However, with the new pharmacovigilance legislation those studies are formally recognised. It is clarified that marketing authorisation holders can be obliged to conduct such studies by imposing that obligation as a condition to the marketing authorisation. Moreover, competent authorities may require the performance of such studies even post-authorisation, if new scientific evidence indicate that previous efficacy evaluations might have to be revised significantly.
In this context the Commission is empowered to adopt a delegated act laying down the situations in which post-authorisation efficacy studies may be required.
In order to further explore the added-value and the content of such an act the Commission has prepared a reflection paper which is now being rolled out for public consultation with a view of receiving feedback from stakeholders on this issue.
The consultation document
The consultation document can be downloaded here.
Protection of personal data
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Specific privacy statement
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