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Aug 23, 2021

Updated Records of Clinical Trials Information System (CTIS) Webinar about How Sponsor Organisations can Prepare for CTIS
On 13 August 2021 the EMA updated the records of the CTIS webinar event.

Clinical Trials Information System (CTIS) will act as the single entry point for clinical trials authorisation and supervision in the EEA. CTIS was created as part of the EU Clinical Trials Regulation (Regulation (EU) No 536/2014).

Topics presented during the webinar include how sponsor organisations can prepare for CTIS, how Member States aim to support sponsor preparedness and adoption of CTIS, the role of the Clinical Trial Regulation and how sponsors can best make use of EMA’s CTIS training materials.

A recording of this event is available.

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Transfer of Analytical Methods
On 13 August 2021 the article was published on the MHRA inspectorate blog.

Technical transfer of analytical methods, or analytical method transfer (AMT) is a GMP requirement for those involved in contract manufacturing and testing.

The purpose of this post is to provide guidance to manufacturers and contract testing laboratories for the process of transferring a method for outsourcing of testing. Whilst not included within this post, the requirements of EU GMP Chapter 7 should also be met.

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Clinical Researchers Sentenced in Connection with Scheme to Falsify Drug Trial Data
On 11 August 2021 the US Department of Justice sentenced clinical researchers in connection with scheme to falsify clinical drug trial data.

A federal judge sentenced a Florida nurse practitioner and a Florida woman to prison terms today in connection with their participation in a conspiracy to falsify data related to clinical drug trials.

U.S. District Judge Jose E. Martinez of the Southern District of Florida sentenced Eduardo Navarro, 52, of Miami, to 46 months in prison, and Nayade Varona, 50, of Port St. Lucie, to 30 months in prison. The court also ordered the defendants to pay $2,134,503 in restitution. According to court documents, Navarro and Varona worked at a clinical research site called Tellus Clinical Research (Tellus). Navarro, a nurse practitioner, was a sub-investigator at Tellus, and Varona was an assistant study coordinator. As part of their plea agreements, Navarro and Varona admitted that they conspired with others to falsify data in connection with two clinical trials by, among other things, fabricating medical records to make it appear as though subjects were participating in the clinical trials when, in truth, they were not.

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Regulatory Changes for Software Based Medical Devices
On 9 August 2021 the Australian Therapeutic Goods Administration (TGA) published the guidance on regulatory changes for software based medical devices.

This guidance provides a summary of changes to the regulation of software based medical devices (including software as a medical device - SaMD) that take effect from 25 February 2021. It outlines transition arrangements available for devices that may need to be reclassified or that qualify for an exemption or exclusion from the Therapeutic Goods (Medical Devices) Regulations 2002.

Read the pdf 

Clinical Trials Information System (CTIS) Highlights
On 6 August 2021 the EMA published the issue 4 of the CTIS highlights newsletter from August 2021.

On the 31st of July 2021, a major CTIS milestone has been reached. The coming into application of the Clinical Trials Regulation (EU) No 536/2014 and therefore the go-live date for CTIS has now been confirmed as 31 January 2022, meaning the six-month countdown to CTIS has begun. The European Commission has established this through their notice published in the Official Journal of the European Union.

When CTIS goes live, it will harmonise the submission, assessment and supervision of clinical trials in the EU and the EEA.

CTIS will streamline submission processes for commercial, non-commercial and academic clinical trial sponsors. In addition, it will streamline the authorisation and supervision process for the EU/EEA Member States. The European Commission will play a role in the supervision of the implementation of the Regulation.

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Development and Submission of Near Infrared Analytical Procedures
On 6 August 2021 the FDA published the final guidance on the development and submission of near infrared analytical procedures.

This guidance provides recommendations to applicants to aid the development, validation, and use of near infrared (NIR)-based analytical procedures in evaluating the identity, strength, quality, purity, and potency of drug substances and drug products. The recommendations apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs for small molecule drugs. The principles in this guidance also apply to drug substances and drug products covered in Type II drug master files. FDA intends to issue recommendations specific to NIR methods used for biological products under biologics license applications in a future revision to this guidance. This guidance provides recommendations to applicants for applying the concepts described in the guidance for industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (September 2004) (PAT guidance) and the International Council for Harmonisation (ICH) guidance for industry Q2(R1) Validation of Analytical Procedures: Text and Methodology (November 2005) to NIR analytical procedures that use chemometric models. This guidance also provides recommendations for submitting NIR documentation in applications.

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Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials
On 6 August 2021 the FDA published the final guidance on considerations for metastasis-free survival endpoint in clinical trials.

This guidance provides recommendations to sponsors about using metastasis-free survival (MFS) as an endpoint in clinical trials for nonmetastatic castration-resistant prostate cancer (nmCRPC) development programs for drug or biological products regulated by FDA.

The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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Belgium - Updated Guidance on Submissions re CTAs, Substantial Amendments, and End-of-trial Declaration
On 5 August 2021 the Belgium FAMHP updated the guidance on the submission of clinical trial applications.

This document is intended to update the guidance on the submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the competent authority in Belgium (FAMHP).

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Six-month Countdown to Go-live for the Clinical Trials Information System (CTIS)
On 2 August 2021 the EMA announced six-month countdown to go-live for the CTIS.

The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and hence the go-live date for the Clinical Trials Information System (CTIS) will be on 31 January 2022.

As set out in the Clinical Trials Regulation, the entry into application of that Regulation is set by the publication of a notice in the Official Journal of the European Union, which confirms that the clinical trial EU Portal and Database, one of the main deliverables of the Regulation and the key component of CTIS, has reached full functionality. The application of the Regulation and the go-live of CTIS take place six months after the publication of this notice.

The Clinical Trials Regulation aims to harmonise the submission, assessment and supervision processes for clinical trials throughout the EU. CTIS will allow the streamlining of these processes, ensuring the EU remains an attractive region for clinical research.

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Clinical Trials Regulation (EU) No 536/2014 Draft
Questions & Answers Version 4

In July 2021 European Commission published the draft Q&A guidance on EU clinical trials regulation.

The Q&As were discussed progressively since December 2014. Certain sections of this Q&A document are not yet complete. Updated versions of the Q&A will be published progressively.

Changes compared to superseded version, the Q&As guidance of the version 4 added or revised: Chapter 3 (complete revision), 11.6 (updated), 11.7 (updated), 11.14 (NEW), 11.15 (NEW), ANNEX IV changes to the source country (NEW).

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