Category: Regulatory Update

March 2023: China/WHO Registry Update

On 3 March 2023, the International Traditional Medicine Clinical Trial Registry (ITMCTR) was added to the Primary Registries Network of the International Clinical Trials Registry Platform (ICTRP) by the World Health Organization (WHO). It is the first cross-regional clinical trial registry that targets traditional medicine, in the WHO ICTRP registry network.

The ITMCTR is a non-profit online registry that enables voluntary registration of clinical trials conducted in the field of traditional medicine, including but not limited to Chinese medicine, acupuncture, tuina massage, herbal medicine, ayurveda, homeopathy, and complementary and alternative medicine. The registry accepts global registrations, in addition to those conducted in China.

It is governed by the China Academy of Chinese Medical Sciences and The China Center for Evidence-Based Traditional Chinese Medicine.

March 2023: ClinicalTrials.gov Beta Website Update

On March 08, 2023, an update was posted on the Release notes section of the ClinicalTrials.gov Beta website, which reads as follows:

To enhance user-friendliness, the ClinicalTrials.gov Beta website has incorporated new features such as Table view, as well as improvements, and bug fixes.

The key features include:

    • The interventional and observational studies on ClinicalTrials.gov Beta now feature a new Table View that organizes study information in a way that caters to the needs of data researchers and journal editors.
    • To provide more accurate search results, a new label has been added to study records in the Table View.
    • Users can conveniently access studies by including study hyperlinks in CSV downloads.

Additionally, ClinicalTrials.gov Beta will soon introduce a feature that allows users to view record history and compare versions.

For more detailed information on these updates, please visit the Release Notes section of the Beta ClinicalTrials.gov website.

March 2023: Denmark Regulatory Update

On March 02, 2023, the Danish Medicines Agency published the following update in the News section of its website.

Based on the Professional Forum conducted by the Danish Medicines Agency (DMA) and the Danish Centre for Ethics on January 31st, 2023, the DMA has updated its guidelines on the application and conduct of clinical drug trials under the EU Regulation and has included a trial protocol structure template.

With this update, the Danish Medicines Agency aims to provide a condensed overview of the different guidelines and training programs issued by the European Medicines Agency (EMA) and the legislation related to the EU regulation, as well as a question/answer section to supplement the existing guidelines.

The trial protocol template outlines the necessary information to meet the EU regulation and ICH-GCP requirements for a protocol.

More information can be found here.

February 2023: What’s New on ClinicalTrials.gov

On February 08, 2023, the below update was posted on ClinicalTrials.gov, What’s New section:

Good Cause Extension (GCE) Request Process and Criteria.

The Good Cause Extension Request Process and Criteria is a document intended to explain to responsible parties the process of submitting a good cause extension request to extend the deadline for submitting clinical trial results information to ClinicalTrials.gov and the information necessary for the National Institutes of Health (NIH) to evaluate and provide a decision for the GCE requests.

New and Updated FAQs are available to clarify the Good Cause Extension Request Process and Criteria.

    • New FAQs:

The same update was posted on Clinicaltrials.gov PRS Test, which will go live on February 15, 2023:

The ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational Studies document has been updated to reflect edits made to the following data fields in the Delayed Results section.

    • Appeal Justification
    • Requested Submission Date (Day now required)
    • Explanation

January 2023: What’s New on ClinicalTrials.gov

On January 31, 2023, the below update was posted on ClinicalTrials.gov, What’s New section:

ClinicalTrials.gov Beta Website:

New search features, Improvements and bug fixes are added to make the ClinicalTrials.gov Beta website more user-friendly.

The key features include:

Moreover, the tabular view of the study record will be coming soon.

Detailed information on the updates can be found at Release Notes | Beta ClinicalTrials.gov.

January 2023: France Regulatory Update

On January 19, 2023, a press release was posted on the Ministry of Health and Prevention website’s News/Press page.

On January 18, 2023, work on a minimum viable product (MVP) of a national clinical trial database related with the Information System for Research Involving the Human Person (RIPH 2G) was launched.

During the first half of 2023, the Directorate-General for Health (DGS) and the Digital Health (DNS) along with the Agency for Health Innovation (AIS), will begin work on implementing a national basic MVP for clinical trials. This initiative is a part of the health component of France 2030 “Health Innovation Plan 2030.”

The MVP will be called ECLAIRE (Accessible Interconnected Clinical Tests for Research Open to the Ecosystem).

Santé.fr will be the MVP’s first interface with the national base, with the potential highlighting of certain therapeutic areas according to the public health priorities identified by the Ministry of Health and Prevention.

Working groups in the construction of the MVP will be set up by the end of January, which will include patient associations, manufacturers, and researchers, around themes such as the user experience on Santé.fr, the legal aspects around clinical trial data and the GDPR, the validation circuits of simplified information translated into French as well as the possibility of completing them, and pedagogical elements for volunteers.

Additional information can be found here.

January 2023: Denmark Update

On January 17, 2023, an update on the Professional Forum – Status and experiences following the first year of the Clinical Trials Regulation was posted in the News section of the Danish Medicines Agency’s website.

Hosted by the Danish Medicines Agency (LMST) and the Danish Centre for Ethics (NCE), the Professional Forum will take place on January 31, 2023, from 3:00 PM to 5:00 PM Central European Time (CET). The event aims to address any questions or issues related to the new regulations for clinical trials of medicinal products. The event will be conducted in-person, not virtually.

Participants can register for the forum here and submit any questions via email to the National Center for Ethics by January 20, 2023.

Additional information can be found here.

January 2023: Japan Registry Update

On December 27, 2022, a notice announcing the migration of registered data from the registries, Japan Medical Association Clinical Trial Registry System (JMACCT-CTR) and Japan Pharmaceutical Information Center Clinical Trial Information (JapicCTI) to the Clinical Research Submission and Disclosure System of jRCT was published on Japan Registry of Clinical Trials (jRCT). The listed updates are as follows:

  • The transition date, February 20, 2023, will see a one-day suspension of jRCT. As expected, the revised and relocated data will be accessible in jRCT on February 21, 2023.
  • Study data cannot be updated on JMACCT-CTR and JapicCTI during the migration; however, data can be updated on jRCT once the migration is complete.
  • Changes and new registrations on jRCT are not permitted during the migration, and the changes and registrations must be finished by Thursday, February 16, 2023.
  • The transitional trials will receive a new jRCT number, but jRCT users can still search for them using their individual JMACCT-CTR and JapicCTI trial IDs.
  • The data fields for the transitional trials would adhere to the JMACCT-CTR and JapicCTI guidelines. If any of the WHO24 items are missing for a transitional trial, they can be added and updated on jRCT.
  • JMACCT-CTR and JapicCTI won’t be available after January 31, 2023, and February 21, 2023, respectively.

Please click here to go to the original update.

December 2022: Germany Regulatory Update

An announcement was published on December 15, 2022, on the BfArM website regarding the notification of observational studies according to section 67 para. 6 of the Medicine Act (AMG) and on the non-interventional safety studies according to section 63f AMG.

As per the section 67 and section 63 of AMG regulation, there is an obligation to report the post-marketing observations and non-interventional safety studies (PASS) to the competent higher federal authority without delay. The German Medicine Act has increased the scope of reporting non-interventional safety studies, now the obligation to notify is not limited to studies that prospectively collect primary data, but also includes registers, retrospective studies, secondary data analysis and cross-sectional studies.

Safety studies that were started by October 26, 2012 are to be classified as observational studies and would continue to fall under the regulations of Section 67 Paragraph 6 AMG with regard to the notification and transparency obligations.

More information on this announcement can be found here.

December 2022: What’s New on ClinicalTrials.gov

On December 19, 2022, the below update was posted on ClinicalTrials.gov, What’s New section:

ClinicalTrials.gov Beta Website:

Prerecorded demonstration videos presenting features of PRS Beta and ClinicalTrials.gov Beta and highlighting changes from the classic sites are now available.

New search features, Improvements and bug fixes are added to make the  ClinicalTrials.gov Beta website more user-friendly.

The key features include:

    • Streamlined Homepage to enhance search experience
    • Provision to ‘Add All Filters’ or ‘Reset to Default’ can be accessed by the  Advanced filter dropdown
    • The record history tab has been included in the study records to view a study record’s history of changes. The elements in the study record versions that have changes are highlighted.
    • The dates have been reformatted  from month, day, year (Month DD, YYYY) to year, month, day (YYYY-MM-DD) format.

Moreover, the draft version of the new application programming interface (API) to support the beta website will be coming soon.

Detailed information on the updates can be found at Release Notes | Beta ClinicalTrials.gov.