The new Danish Act on research ethics treatment of clinical trials of medical devices, etc., introduces changes in the rules governing the marketing of medical devices in Denmark. The amendment will adapt to Danish legislation under Regulation 2017/745 on medical devices (MDR) and Regulation 2017/746 on medical devices for in vitro diagnostics (IVDR).
The manufacturers’ duty to report to the Danish Medicines Agency may apply for six months after the EU Commission has announced that the joint European database for medical devices (EUDAMED) is operational. Then the rules of the regulation on manufacturers’ duty to report incidents, reports on results of investigations of incidents and safety-related corrective measures will apply directly, so that manufacturers must report through EUDAMED to the competent authorities.
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.
Click here for the original article.
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.