March 2021: Taiwan Regulatory Update

The new “Medical Devices Act” is set to come into effect on May 01, 2021. This law was announced on January 15, 2020. Earlier medical devices were regulated by the Pharmaceutical Affairs Act, but now they will be part of the Medical Devices Act. Details about clinical trials on medical devices are included in Chapter IV, Article 37-39.

Medical device clinical trials conducted in Taiwan need prior approval from the Taiwan FDA. Sponsors will need to report any serious or life-threatening adverse events related to medical device clinical trials conducted in Taiwan. Even though the regulation includes a generic term called ‘information disclosure’, it has not been elaborated further.

March 2021: EMA Medical Terms Simplifier

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.

March 2021: UK MHRA Pilots Patient Involvement In New Applications

The MHRA has announced a new pilot, which will request, on a voluntary basis, applicant companies of new active substances and new indications to provide evidence of the patient involvement activities they undertook when developing their product.

For clinical trials, whilst additional information won’t be requested at this early exploratory stage of the pilot, the MHRA will be documenting in medical assessment reports if there is evidence of patient involvement in clinical trial applications in order to better understand the current scope of activities.

In considering how patient involvement is integrated into the approvals process, the MHRA hopes to learn from any patient-related activities that take place during development, and use this knowledge to improve the quality of clinical drug development and health outcomes in the future. During the pilot, the information provided by the applicants will be voluntary and will not alter the outcome of their application. However, in future, the agency hopes that a successful pilot will lead to patient involvement playing a greater role in the final assessment process, when clinical trials are approved, or medicines are licensed.

The agency will undertake a detailed analysis of the evidence submitted. This crucial patient-focused pilot supports the ambitious vision of The Future of UK Clinical Research Delivery. As a partner, the MHRA is proud to be part of strengthening and contributing to this project.

For more information, please click here.

March 2021: Clinical Trials Information System (CTIS) Training Update

European Medical Agency updated the page Clinical Trails Information System: training programme, on March 10th, 2021, by adding the below training materials in PDF format for Module 8 :

  1. Quick guide – Introduction: How to evaluate an Initial Clinical Trial Application: Assessment and Decision – CTIS Training Programme – Module 08
  2. Quick guide – Decision: How to evaluate an Initial Clinical Trial Application: Assessment and Decision – CTIS Training Programme – Module 08
  3. Quick guide – Part I: How to evaluate an Initial Clinical Trial Application: Assessment and Decision – CTIS Training Programme – Module 08
  4. Quick guide – Part II: How to evaluate an Initial Clinical Trial Application: Assessment and Decision – CTIS Training Programme – Module 08

 

March 2021: EMA Management Board Meeting

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.

March 2021: What’s New on ClinicalTrials.gov

The below update was posted on What’s New section of ClinicalTrials.gov with respect to ClinicalTrials.gov modernization, on March 09, 2021, in addition to the reiteration of the ClinicalTrials.gov PRS update:

Modernization Webinar Materials are now available. A recording of the February 18 webinar and slides describing the progress of the    modernization effort are added to the ClinicalTrials.gov Modernization page, including information on how to volunteer to provide user feedback.

March 2021: CTIS Training Webinars Update

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.

March 2021: What’s New on ClinicalTrials.gov PRS

The below update was posted on the What’s New section of ClinicalTrials.gov PRS for March 04, 2021:

PRS Guided Tutorials
The PRS Guided Tutorials have new and updated content and features to make them more useful in response to feedback obtained through focus groups and survey responses over the past year. Enhancements include updated images and improved zoom functionality, additional study examples from materials developed for the behavioral sciences community, and revisions to the Introduction and tutorial content for added clarity and guidance. Two new sections have also been added: Quick Start Guides are designed to help users get the most from the tutorials, and the PDF Library has all of the tutorial content in a single place, readily available for download. Please note that audio narration has been removed.

February 2021: CTIS Training Webinars Update

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.

February 2021: ClinicalTrials.gov Modernization Update

The following updates were communicated by NLM with respect to ClinicalTrials.gov modernization, on February 10, 2021:

Progress Towards a Modernized ClinicalTrials.gov
ClinicalTrials.gov acting director Rebecca Williams, PharmD, MPH, has authored a guest post on the National Library of Medicine Musings from the Mezzanine blog. Read the post to learn more about the progress to modernize ClinicalTrials.gov.

Webinar on ClinicalTrials.gov Modernization
Reminder to mark your calendars for an update on the ClinicalTrials.gov modernization effort on February 18, 2021, from 3 to 4 p.m. ET. Please register via the ClinicalTrials.gov
webinar registration page to attend the live event. A recording and the presentation slides will be posted after the webinar.