EC updates Clinical Trial Regulation Q&As ahead of January go-live
The European Commission has issued an updated question-and-answer guidance clarifying certain aspects of the Clinical Trials Regulation (CTR), which is set to go into effect this January.The revision clarifies that active pharmaceutical ingredients (APIs) used in investigational medical products do not have to comply with good manufacturing practices (GMPs) in the clinical trial application, describes the content of the protocol synopsis, and adds a new question on how sponsors should report the dates that annual safety reports (ASRs) are to be submitted for investigator-initiated trials.
The updated version of the question-and-answer document replaces the previous version issued in July, and is being issued ahead of the 31 January 2022 full launch of the CTR. The new regulation will replace the clinical trials directive, which has been in place since April 2001.
Among the changes: The update adds language in question 5.8 related to the protocol synopsis described in Annex I of the regulations on the contents of the clinical trial application dossier.
A lay person should be able to understand the protocol synopsis, according to the updated language. “The protocol synopsis can be part of the protocol or a separate document (e.g. when it is submitted in different language versions), in the latter case, it should always be submitted to CTIS [Clinical Trials Information System] together with the protocol.”
Another change: The update adds language in question 8.4 related to the documentation needed to show compliance with GMP in the clinical trial application. The revision clarifies that “information regarding the GMP compliance of the active pharmaceutical ingredients is not required by the CTR (and can therefore not be required by the Member States Concerned).”
The update also adds a new question 7.39 on how sponsors should report the dates that annual safety reports (ASRs) are to be submitted for investigator-initiated trials.
The answer: “In order to facilitate safety cooperation it is recommended to clarify within cover letter of the initial trial application the anticipated date of ASR submission based on the Development International Birth Date (DIBD) used to determine the start of the annual period for the DSUR (date of sponsor’s first authorisation to conduct a clinical trial in any country worldwide) or in case of clinical development following a marketing approval in any country worldwide and if desired by the sponsor, based on the PSUR [Periodic Safety Update Report] International Birth Date (IBD).”
In addition, it states that “in cases when a single ASR is submitted for more than one IMPs… the sponsor should indicate in the cover letter the intended submission date for the first ASR following trial authorization.”
The EU’s clinical trial regulation was adopted and entered into force in 2014, with full application awaiting the full functionality of a clinical trials portal and database. The database will go live in January as the CTR launches.
EC updated guidance on clinical trial regulation
×
Welcome to the new RAPS Digital Experience
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.
We welcome your feedback. Please let us know how we can continue to improve your experience.