As a part of the regulatory modernization process, Health Canada had published a consultation paper in May 2021. Health Canada gathered feedback from stakeholders on the consultation paper through an online questionnaire, email submissions, and interactive webinars. Overall, 122 written submissions and close to 1000 stakeholders participated in webinars.
The respondents agreed with the proposals to modernize the clinical framework. Health Canada posted “What we heard: an executive summary” on their portal on February 23, 2022. One of the topics in the post was transparency. Most respondents saw value in the new transparency policy/ regulation for registering trials and reporting results. Support from the academic community was 73% and that from the industry was 54%.
Most respondents (86%) register their trials with an international registry like ClinicalTrials.gov. Some use the EU Clinical Trial Register and 1 respondent recommended ISRCTN. For device trials, EUDAMED will be also be used once it becomes a law.
Feedback suggested that academic researchers have challenges in keeping their international registration up to date as compared to the industry researchers. The major challenge included the burden of being required to use multiple registries in different countries for multinational trials. Other challenges included resource requirements to keep up-to-date registry information and some registries being not user-friendly.
Public disclosure of results:
Most respondents (73%) report trial results in the international registries. Respondents explained that reporting results is a part of their good clinical practices and some explained that reporting is an international, research ethics board or publication requirement. Of the 27% of respondents who were contract research organizations (CROs) said they do not report their results. Most of them said it is the sponsor’s responsibility. Some (20%) who do not report their results on international registries said they publish results on their company websites.
The detailed information can be found here.
The Spanish Agency of Medicines and Medical Devices (AEMPS) has published an updated version of document of instructions of the Spanish Agency of Medicines and Health Products for the realization of clinical trials in Spain.
As per updated version, from 31 January 2022 until 30 January 2023, the sponsor may request the authorization of a clinical trial, applications for substantial modifications through the CTIS or ECM Portal.
All requests and communications subsequent to the authorization of a clinical trial not uploaded to CTIS must continue to be made through the ECM portal no later than the date on which the transition of the clinical trial was requested in the CTIS Portal.
Canadian Institutes of Health Research (CIHR) shared their policy guide on the requirements for the registration and disclosure of results from clinical trials on February 08, 2022.
The policy focuses on the registration of clinical trials and making them publicly available, free to access before the first visit of the first participant.
The following new requirements will be applicable to all clinical trials funded on or after January 01, 2022:
- Publications including clinical trial results must be open to access from the date of publication.
- Summary of the clinical trial results must be publicly available within 12 months from the last visit of the last participant.
- All study publications must include the registration number/trial ID in the article summary or abstract.
More information can be found here.
The Pan African Clinical Trials Registry (PACTR) and South African Clinical Trials Registry (SANCTR) have made an important announcement on a few enhancements to improve the functionality of the registry.
New filters have been included for easy tracking of the “submitted” or “in process” trials. Researchers should see their trials under “My trials” tab for the new changes. Trials with specific status such as “submitted”, “in process”, “approved”, “denied” or “incomplete” can be viewed using the filters.
The deployment of the changes is expected from February 03, 2022.
The revised enhancements in the registry will be available at www.pactr.org and the SANCTR site.
State Institue for Drug Control (SÚKL) specified the requirements for the documents to be submitted with Part II of the application for clinical trial authorization on January 26, 2022.
Requirements to be entered into Clinical Trial Information System (CTIS) in Part II is elaborated for following sections:
- Patient information sheet / informed consents
- Materials for trial subjects
- Recruitment materials
- Trial site
- Personal data processing
- Biological samples for future research
- Trial subject remuneration and compensation
- Financial coverage – how the clinical trial will be financed
- Proof of fee payment
For more detailed information, click here.
The Management Board heard an update on recent activities in response to the pandemic. The Board was updated on the status of the Agency’s ongoing COVID-19 lessons learned exercise. As part of this exercise, some of the measures and actions taken by EMA and the network in response to the pandemic are being discussed and reflected upon across a number of areas. Over the next few months, the Agency will discuss its findings and recommendations with the network in collaboration with the Heads of Medicines Agencies (HMA). The Board will be updated in December.
Face-to-face scientific committee meetings will be relaunched from the end of October, as a pilot, alternating on-site with remote meetings on a monthly basis.
Mid-year report 2021 adopted
The Agency’s report of activities in the first half of 2021 shows that requests for scientific advice for human medicines increased in the first six months of 2021 compared to the same period in 2020 predominantly due to many developers seeking advice for their COVID-19 vaccines and treatments. EMA received 46 requests for advanced therapy medicinal product (ATMP) classification in the first six months of 2021. Significant efforts were devoted to tackling vaccine hesitancy in the first half of 2021, including extensive public communication, webinars, and information on the EMA website on COVID-19 vaccines. The mid-year report will be published on the EMA website shortly.
Progress on EU IT systems required by the Clinical Trial Regulation
The Clinical Trial Regulation will come into application and the Clinical Trial Information System (CTIS) will go live on 31 January 2022. The Board noted the progress in the development and preparations for ‘go-live’ of CTIS and the CTIS global go-live plan. The CTIS functionalities, agreed for the go-live release, have been delivered and the focus is now on stabilising the system. EMA is providing tools and support to Member States and sponsors, and their staff, to facilitate preparations for go-live. CTIS is the cornerstone for application of the CTR. Clinical research and patient health in the EU will benefit from the streamlined regulatory processes that the Regulation and CTIS will bring.
After the upgrade to Center for Drug Evaluation’s website on September 13, 2021, the “Applicant’s Window” login for the platform (also known as Drug Clinical Trial Registration and Information Disclosure Platform) is now available along with the old system account login.
As mentioned in the “Instructions for Drug Clinical Trial Registration and Information Disclosure Platform V2.0“, in order to ensure the authenticity of the applicant’s identity and the authenticity and validity of the registration information, the platform uses the real-name Ukey account in the “Applicant Window” column of the Drug Evaluation Center to log in, and supports account password login and certificate login at the same time. The platform supports the login of the “Applicant’s Window” account and the original platform (old system) account.
The user is required to link the old system account with the Applicant’s Window account (known as account docking), as per the given process. Once this process is complete, user can login only through the Applicant’s Window and the old system account will not support the login.
Upgrade of China’s Center for Drug Evaluation Website
The Center for Drug Evaluation’s website will be upgraded and deployed from 19:00 on September 10, 2021 to 7:00 on September 13, 2021. The clinical trial registration platform (also known as Drug Clinical Trial Registration and Information Disclosure Platform) will be temporarily closed, and the new version of the website will enter the trial operation stage after the deployment is completed.
This website upgrade has further expanded the scope of applicants’ online business processing, adding different columns like “eCTD Column”, “Guiding Principles”, “Information Disclosure” etc. The deployment structure has been further enhanced, and the electronic document submission of applicants has been encrypted and protected, and the overall security of the website has been improved with enhanced service capabilities.
New Application (VO) Form and New Format for Authorisation Applications and Changes/Notifications/Reports Regarding Clinical Trials with Medicinal Products as of 13 September 2021
According to an update posted by Swissmedic (Swiss Agency for Therapeutic Products), authorisation applications and changes/notifications/reports regarding clinical trials with medicinal products must be submitted to structure (“eDoc” structure), a new application form (“VO form”), and to a new address for submissions from 13 September 2021. Any submissions according to the old submission procedure will be deemed to be formally deficient. However, purely paperless submissions will not yet be possible as of 13 September 2021 and will be implemented at a later date. Therefore, the submissions would still be made on paper and on CD even after 13 September 2021, confirming that the files on the CD are identical with the paper documents.
For more information on the documents and instructions needed for the new procedure, please refer Clinical Trials on Medicinal Products.
On August 23, 2021, Health Canada posted an update on the consultation paper
that was released on May 20, 2021. This consultation paper focuses on the key policy proposals to modernize Canada’s clinical trials regulatory framework. One of the points discussed was clinical trial transparency. Along with the consultation paper, an online questionnaire was provided to seek feedback from the interested industry and non-industry stakeholders including all interested Canadians.
Interested stakeholders could refer to the consultation paper and send feedback either via an online questionnaire or by sending a written submission by email. The consultation feedback ran from May 20, 2021, till July 04, 2021.
The feedback received during this consultation will help make a decision with respect to outstanding proposed regulatory policy, and program consideration for each product line in the future.
A summary report on the discussions and comments received named “What we heard” is planned to be published in fall 2021.