The content and layout of the current Certificate of Suitability (CEP) remains very similar to the original created in 1992. The EDQM is nonetheless well aware of the far-reaching effects that globalisation, the rise of digital technology and many other major regulatory and scientific developments have had on the pharmaceutical industry and competent authorities over the last three decades and, in response, is launching a project to design the CEP of the future. The aim is to develop a “new-look” CEP that will better fit the emerging needs of stakeholders and offer both enhanced user-friendliness and greater transparency of the information conveyed without, however, increasing the administrative regulatory burden related to their revision.
In this context, the EDQM wishes to gather general feedback from stakeholders in the industry and from National Competent Authorities worldwide on various aspects connected with the CEP, particularly its content, layout, format and use.
The consultation will remain open until 31 December 2020 in the form of an online survey. The responders are also given access to a “read only” version of the survey to help them prepare their answers in advance.
Following the public consultation, feedback from stakeholders will be studied in detail. All the information provided will help shape the CEP of the future.