ECA Foundation

ECA

The goals of the ECA Foundation are: To facilitate the exchange of information between representatives of the industry, the medicines authorities and the universities in the field of pharmaceutical quality assurance, especially with regard to the area of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) To promote the move towards a harmonised set of GMP and regulatory guidelines by providing information and interpretation of new or updated guidances and to issue position papers where appropriate to influence and harmonise regulations and to facilitate networking

Lobbying Activity

Response to Rules on good manufacturing practice for active substances used as starting materials in veterinary medicinal products

18 Feb 2025

Please find attached the comments of the ECA Foundation / European QP Association
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Response to Uniform rules on good manufacturing practice for veterinary medicinal products and active substances

18 Feb 2025

Please find attached the comments of the ECA Foundation / European QP Association
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Response to Evaluation and revision of the general pharmaceutical legislation

25 Jun 2023

Please find the comments of the ECA Foundation & European QP Association in the attached file.
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Response to Labelling requirements for unauthorised medicinal products used in Clinical Trials

29 Jun 2022

The IMP Working Group within the European QP Association very much appreciates the ongoing revision of Annex VI to Clinical Trial Regulation (EU) No 536/2014. We fully agree that re-labelling procedures of immediate packaging could add significant safety and quality risks to clinical trial medication. At the same time omitting the expiry date on immediate packaging is not seen as additional risk for patients in a clinical trial, since participants will be thoroughly instructed and closely monitored during the clinical trial. Furthermore, we would like to propose to return to Annex 13’s option to omit the labelling of the expiry dates under exactly defined circumstances using state-of-the art digital systems (IRT – Interactive Response Technology). The expected benefit of this workable solution is to minimize quality risks to clinical trial medication in early clinical phases, where based on limited stability data, the expiry date is continuously expanding. This option would be especially important for refrigerated or frozen IMPs (biological IMPs, ATIMPs, etc.). The Commission may want to consider that procedures have meanwhile been implemented successfully in Member States allowing current clinical trials performing safely under this concept, for example the Federal Institute for Drugs and Medical Devices, Germany (Can statement of the expiry date in the labelling of IMP be omitted when using IVR/IWR systems - please see https://www.bfarm.de/EN/Medicinal-products/_FAQ/Clinical-trials/Pharmaceutical-quality/Labelling/faq-liste.html?nn=880414, FAQ clinical trials).
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