September 2021: UK Regulatory Update

Implementation of UK HRA’s New Reporting Standards for Clinical Research

As per the latest update from UK Health Research Authority, new reporting standards have been implemented to ensure that all researchers fulfill their responsibilities to make their research open and transparent. This is in line with the commitments set out in the Make it Public research transparency strategy.

From Wednesday 15 September health and social care researchers are expected to submit information at the end of their research study to the HRA online, explaining how they have fulfilled their transparency responsibilities. This is part of a set of changes which make it easy for researchers to be transparent and enable the HRA to know whether they are meeting the requirements.

This will also enable to see more clearly what proportion of studies are fulfilling transparency requirements, including information about study registration, publication of results, informing participants of the outcome of the study and the sharing of data and tissue (if applicable).

In order to standardize the information submission, a New Final Report Form had been published.

September 2021: Peru Update

A notification (PRESS RELEASE No. 005-2021-OGITT/INS) dated September 09, 2021, was published on the Peruvian Registry of Clinical Trials (REPEC) website on September 13, 2021. In context of the same:

Due to preventive maintenance, services of the REPEC Version 2 System will be temporarily suspended as of Sunday, September 12, 2021. The services provided in the previous version of REPEC (REPEC Version 1) will continue as normal.

Note: As of September 15, 2021, the registry website (Version 2) is not yet working.

September 2021: China Update

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.

September 2021: China Update

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.

September 2021: Switzerland Update

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.

August 2021: US Regulatory Update

FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.gov

The FDA issued a Notice of Noncompliance on August 31, 2021, to Andrey Petrikovets, M.D. (responsible party) affiliated to University Hospitals Cleveland Medical Center, for failing to submit required summary results information to ClinicalTrials.gov. The company failed to update the study results for their applicable clinical trial (ACT) within 30 days after the first notice was issued. The company’s applicable clinical trial compared ICE-T postoperative multimodal pain regimen to the Standard regimen in patients undergoing same day vaginal pelvic reconstructive surgery.

The prenotice was issued on July 20, 2020, alerting Andrey Petrikovets to potential noncompliance with the requirement to submit clinical trial results. Although the trial’s results were made public in a medical journal, journal publication does not satisfy ClinicalTrials.gov disclosure requirements. On November 30, 2020, Andrey Petrikovets responded, stating that they were very busy with the “Covid surge” and were short staffed. FDA recognizes the unique circumstances that the pandemic presents, and believes they have provided ample opportunity to submit the required results information. The Notice of Noncompliance gives Andrey Petrikovets 30 days to submit the required summary results information. The FDA is authorized to seek civil monetary penalties for Andrey Pretrikovets’s violation, including additional civil money penalties if Andrey Petrikovets fails to submit the required information within the 30-day period.

The Notice of Noncompliance has been posted to the FDA’s website and information about the noncompliance has also been posted on the study record on ClinicalTrials.gov by NIH. NIH will continue to update the ClinicalTrials.gov records for applicable clinical trials that are the subject of a Notice of Noncompliance with information regarding whether the noncompliance has been corrected and the amount of civil money penalties assessed if any.

For more information, please refer to the Letter of noncompliance on the FDA Website: Non-compliance letter

August 2021: Integrated Research Application System (IRAS)

On August 31, 2021, MHRA launched new systems functionality to support the combined review of Clinical Trials of Investigational Medicinal Products (CTIMPs). The combined review service (previously known as ‘combined ways of working’) offers a single application submission route and a coordinated review for CTIMPs, resulting in a combined regulatory and ethics decision on a clinical trial.

The trial sponsors can now manage their complete trial lifecycle via combined review using the Integrated Research Application System (IRAS) – from initial application through to amendments, safety reporting, end of trial notification and submission of summary results. From January 01, 2022, the combined review will become the only way to apply for CTIMP approvals.

August 2021: Canada Update

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.

August 2021: Combined Review Service for CTIMPs applications

Formerly known as the Combined Ways of Working (CWoW), the new Combined Review Service, will be utilised to submit new Clinical Trials of Investigational Medicinal Products (CTIMPs) applications from January 01, 2022. It encompasses a “single submission, a coordinated review, and combined communications” process to facilitate all communications between the authority and all the CTIMP sponsors and applicants.

The system will allow the sponsor or applicant to submit a single application to both the MHRA and Research Ethics Committee (REC). The consequent MHRA authorization and REC opinion would thereby be delivered together in one step. This streamlined process will also apply to further requests sponsors or applicants make for any substantial amendments to the trial authorisation. The system will also allow viewing and revision of the application information directly in the system.

The facilitate the transition, NHS has released a step by step guide to using IRAS for combined review – Health Research Authority (hra.nhs.uk).

July 2021: European Commission Decision On CTIS

The European Commission has published the decision (L275) in the Official Journal of the European Union, today (July 31, 2021) announcing that the EU portal and the EU database have achieved full functionality and meet the functional specifications, as referred to in Article 82(2) of Regulation (EU) No 536/2014. This Decision shall enter into force on the day of its publication in the Official Journal of the European Union (31 July 2021).

On 21 April 2021, the Management Board of the Agency, on the basis of the independent audit report delivered on 8 April 2021, informed the Commission in accordance with Article 82(2) of Regulation (EU) No 536/2014 that the EU portal and the EU database have achieved full functionality and the systems meet the functional specifications published by the Agency.

On the basis of the information provided by the Management Board of the Agency, the Commission verified that the EU portal and the EU database fulfilled the conditions of the full functionality and of compliance with those functional specifications. For more details, please refer to the Commission Decision (EU) 2021/1240 of 13 July 2021 on the compliance of the EU portal and the EU database for clinical trials of medicinal products for human use with the requirements referred to in Article 82(2) of Regulation (EU) No 536/2014 of the European Parliament and of the Council.