April 2021: France Regulatory Update

An article France: Key institutions pledge to make clinical trial results public was published by TranspariMed, on April 06, 2021.

Along with the statements regarding the intention of making clinical trials public from the 5 largest medical research institutions in France, the article has information concerning a letter from the National Agency for Medicines and Health Products Safety (ANSM) to Transparency International France. The French regulator has noted in this letter to sanction a fine of 15,000 Euros or up to a year in prison in a case of non-compliance of publication of clinical trial results once the European Union regulation fully comes into force.

It has been also highlighted by TranspariMed that it is not yet clear if these sanctions will be directly imposed by ANSM or through a court. Additionally, ANSM did not specify whether an inspection process is in place to monitor sponsors’ compliance with their trial reporting obligations, or if there are plans to do so in the future.

Click here for the original article.

April 2021: Switzerland Regulatory Update

Updates on Medical Device Regulation (ClinO-MD)

In the course of adapting Swiss legislation to the new EU Medical Device Regulation (MDR), clinical research with medical devices (with the exception of in vitro diagnostics) in Switzerland will be regulated in a separate ordinance. The new “Medical Device Regulation” (ClinO-MD) will come into force on May 26, 2021, at the same time as the MDR.

According to the update posted on the Swiss National Clinical Trials Portal (SNCTP) on April 20, 2021, in addition to the existing obligation to prospectively register the clinical trial, the results of the trial must now also be published in a trial registry. This will also apply to clinical trials which will be still underway when the ClinO-MD enters into force on May 26, 2021. As Eudamed cannot currently be used for this purpose, the registration and publication of results must therefore be carried out in an international trial registry, such as ClinicalTrials.gov.

Other than the disclosure requirements other changes regarding clinical trials with medical devices under the ClinO-MD are:

  • Updated categorization of the medical devices
  • Differentiating clinical trials as  conformity-related and non-conformity-related
  • Adaptation of application documents to be submitted
  • Reply deadline for sponsors

For more details, please refer to Clinical trials with medical devices: Expected changes in the legal requirements.

April 2021: Denmark Regulatory Update

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.

April 2021: US Regulatory Update

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

FDA issued a press release on April, 28th FDA Takes Action for Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov announcing that a Notice of Noncompliance which was sent to Acceleron Pharma  for failing to submit required summary results information to ClinicalTrials.gov. The company’s applicable clinical trial evaluated the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma.

The prenotice was issued on July 20, 2020, alerting Acceleron to potential noncompliance with the requirement to submit clinical trial results. The Notice of Noncompliance gives Acceleron 30 days to submit the required summary results information. The FDA is authorized to seek civil money penalties for Acceleron’s violation, including additional civil money penalties if Acceleron fails to submit the required information within the 30-day period of issuance of this notice.

The Notice of Noncompliance has also been posted to the FDA’s website and information about the noncompliance will be 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.

April 2021: Republic of Korea Regulatory Update

Notice for Partial Correction of Input Items and Changes to Existing Registered Research Data

Clinical Research Information Service (CRIS), the primary registry of Korea published a notice on 20 April 2021. In context of the same:

  • Recently, WHO ICTRP announced that some of the choices in the Study Data Sharing Plan for the International Clinical Research Registration Guidelines have been removed. In accordance with the same, CRIS has deleted the “Undecided” selection in the research data sharing plan and changed the registered research data. In case “tentative” is selected for existing registered studies, it has to be changed to “No”.
  • For previously registered studies, where “Undecided” was selected, the data will be changed to “No” collectively. Research that corresponds to data bulk changes will be sent to the registrar’s email. Sponsors can change it to “Yes” if their IPD sharing plan changes.
  • Modifications to input items and changes to existing registered research data are expected further.
  • Detailed information can be accessed through Announcements (nih.go.kr)

April 2021: Republic of Korea Regulatory Update

Notice of Temporary Suspension of the Functions of CRIS (Primary Registry of Korea) due to Homepage Renewal Work

Clinical Research Information Service (CRIS) published a notice on April 20,  2021. In the context of the same:

  • Due to the renewal of the Clinical Research Information Service (CRIS) website, functions related to clinical research registration are temporarily suspended (until April 22, 2021).
  • The functions of creating, submitting, supplementing, registering, and renewing clinical research are temporarily suspended. Other clinical research inquiry functions are serviced normally.
  • Modifications and changes related to input items are expected further.

April 2021: Spain Regulatory Updates

Publication of Observational Studies with drugs in the Spanish Registry of Clinical Studies

AEMPS posted an update regarding the new platform for the publication of observational studies with drugs in the Spanish Registry of Clinical Studies on April 14, 2021. The trial registration and results posting activities for these will be carried out through GESTO platform, launched on 14th April 2021.

Additionally, as informed earlier by the authority, a document Instructions for conducting observational studies with drugs: Procedures, terms and data format that will be included in the Spanish Registry of clinical studies (REec) has also been made available. The document provides details in compliance with the provisions of Article 3.1 and 6.2 of Royal Decree 957/2020, of November 3. The points are summarized as below:

User account and login information:

  • Account requests and related incidents can be raised through https://servicedesk.aemps.es/servicedesk/customer/portal/2
  • The promotor (individual, company, institution or organization responsible for initiating, managing and organizing the financing study) or representative of a promotor [who will be the sole point of contact for the study promoter (applicant) from registration of trial] can register

Requirements:

  • Publication of information is mandatory for observational studies with prospective follow-up drugs and voluntary for the rest of the studies

Timelines:

  • Registration: Maximum 15 working days from the start date of the study
  • Maintenance: The updating of the data must be carried out within 15 days working from the date the CEIm has issued a favorable opinion to the substantial modification
  • Results: Results will need to be submitted within 12 months from study completion or within 30 working days from the date of publication of the same in scientific journals or other media, whichever is earlier
  • For early terminated trials, information will need to be updated within 3 months from the trial termination date

Trial registration and results posting (Data entry):

  • Details regarding the registration fields, fields that will be made public and other fields that will not be displayed publicly are available on below link, https://www.aemps.gob.es/investigacionClinica/medicamentos/docs/estudios-PA/Instrucciones-GESTO-REEC.pdf?x74012
  • Information for the below-mentioned fields will be submitted to GESTO, however, these fields will not be published on REec:
    Promoter ID, Contact for scientific inquiries, Identification of the principal investigator/coordinator, Contact information, CEIm that approved the study, Meeting date CEIm Opinion, Study status (started, finished), End date, Summary of Results, Post link, Date of the last modification of the record in the REec
  • Results will be submitted either in the form of a summary of trial results or bibliographic reference of the published scientific article
  • The AEMPS will check the consistency of the information provided and will proceed to transfer the information to the REec

February 2021: European Regulatory Update

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.

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.

January 2021: Peru Regulatory Update

Update on New Version of Peruvian Registry of Clinical Trials (REPEC)

Peruvian Registry of Clinical Trials (REPEC) published a notification (COMMUNICATION N ° 002-2021-OGITT / INS) on January 28, 2021. In context of the new version of the REPEC, developed by the National Institute of Health (INS):

  • Any application for new registrations (Sponsor/OIC registration, Research Center registration, Ethics Committee registration, clinical trial authorization), must be made through the newly enabled REPEC Platform.
  • The previous REPEC platform will continue to record amendments, reports of adverse events, progress reports, deviations, among others, as well as changes in the conditions of authorization of clinical trials authorized until 2020, with the exception of clinical trials that have as a research product “vaccine candidates” which must use the new REPEC platform.