An article France: Key institutions pledge to make clinical trial results public was published by TranspariMed, on April 06, 2021.
Along with the statements regarding the intention of making clinical trials public from the 5 largest medical research institutions in France, the article has information concerning a letter from the National Agency for Medicines and Health Products Safety (ANSM) to Transparency International France. The French regulator has noted in this letter to sanction a fine of 15,000 Euros or up to a year in prison in a case of non-compliance of publication of clinical trial results once the European Union regulation fully comes into force.
It has been also highlighted by TranspariMed that it is not yet clear if these sanctions will be directly imposed by ANSM or through a court. Additionally, ANSM did not specify whether an inspection process is in place to monitor sponsors’ compliance with their trial reporting obligations, or if there are plans to do so in the future.
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Clinical Trials Information System Reaches Major Milestone Towards Go-Live
As per the latest update posted on 21 April 2021, EMA’s Management confirmed that the clinical trial EU Portal and Database, one of the main deliverables of the Clinical Trial Regulation and the key component of the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 2022.
The Board confirmed that it has verified that the system meets the agreed requirements during an extraordinary meeting held on 21 April following an independent audit of the new IT system.
The below update was posted on EudraCT What’s New section, on April 16, 2021:
A new version of the Frequently Asked Questions is now available for users and more detailed instructions are now provided in the tutorials on posting results.
- Q. 30: Provides more information regarding a third country trial
- Q. 55: Provides an additional reference for contents of results information to be included in a summary attachment
- Q. 67: Question updated to add ‘user or delegated preparer’
- Q. 70: Provides information for a sponsor to directly upload a PDF document; previously, the NCA was to be contacted who would then upload the document
- Q. 78: Statement added ‘A link to the old version will remain published in the EU CTR to keep track of the changes and for transparency reason.’
- Q. 81: Addition of statement about errors and warning
- Minor grammatical and typographical corrections
TranspariMed published an article How will national regulators in Europe impose fines for missing clinical trial results?
In this article, TranspariMED’s legal analyst Muhammad Dwistaraifa Rasendriya explains the legal context and how the process will work. As a summary, even though national medicines regulators will get clear legal powers to impose fines and other sanctions on European companies and institutions that fail to make the results of their drug trials public, there will be variation in the amount/type/applicability of the penalty depending on what act/law is passed in each EU country.
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EMA published a document “EMA Medical Terms Simplifier” on March 19, 2021.
This compilation gives plain-language descriptions of medical terms commonly used in information about medicines. The list includes side effects and similar terms in summaries of product characteristics and
public assessments of medicines but does not extend to the terms that are used only rarely.
EMA will update the document periodically.
The EMA Management Board meeting took place on March 11, 2021, and the highlights for the same were published on March 12, 2020.
As noted in the report, the Board agreed to revise the go-live date to 31 January 2022. This go-live date is the aspiration of the Board, being without prejudice to verification of the final audit outcome and full functionality of CTIS by the Management Board, and the subsequent decision process of the European Commission. The final go-live will take place exactly six months after the publication of the Commission decision in the Official Journal of the European Union.
Day 2 of the SME and academia Clinical Trials Information System (CTIS) two-part training webinar arranged by EMA took place on March 04, 2021. EMA has made available the presentations from Day 2 of this CTIS training webinar on March 03, 2021.
Clinical Trials Information System (CTIS) Training: Day 1 Webinar Presentations
SME and academia Clinical Trials Information System (CTIS) two-part training webinar was announced on 19/01/2020. Day 1 of the webinar was held on 22 February 2021. Presentations were provided by EMA system experts, European Commission, and presenters from SME and academic institutions during the webinar. The presentations from the Day 1 of the CTIS training webinar were made available by EMA on 26 February 2021.