WSQMS Homepage

 

Nov 29, 2021

 
Updated Instructor’s Guide: Introduction to the Clinical Trials Regulation (EU) No 536/2014
On 15 November 2021 the EMA published the updated guidance on the instructor’s guide of CTIS training program module 1.

This guide is focused on the first Module of the CTIS Training Program (hereafter referred to as 'CTTM01') which provides a basic introduction to Regulation EU No 536/2014 on clinical trials on medicinal products for human use (the Clinical Trials Regulation). This guide contains an overview of the audiences targeted, the training materials available, and a proposal of a methodology for disseminating the materials of CTTM01.

Read the pdf 



Updated FAQs: Introduction to the Clinical Trials Regulation (EU) No 536/2014
On 15 November 2021 the EMA published the updated guidance on the FAQs of CTIS training program module 1.

In this document, the common questions regarding Module 1: Introduction to the Clinical Trials Regulation (EU) No 536/2014 are listed. They are categorized into three subsections focusing on definitions, the transition from the regime of Directive 2001/20/EC (Clinical Trials Directive) to the Clinical Trials Regulation, as well as the rules of transparency of clinical trials data, established in the Clinical Trials Regulation. This document has been prepared taking into account the Clinical Trials Regulation itself and the European Commission’s Questions & Answers Draft document on the Clinical Trials Regulation.

Read the pdf 



Good Laboratory Practice (GLP) for Safety Tests on Chemicals
On 15 November 2021 the UK MHRA updated the GLP guidance.

Any test facility which conducts, or intends to conduct, regulatory studies must comply with good laboratory practice (GLP) regulations when carrying out safety tests on:

  • pharmaceuticals
  • agrochemicals
  • veterinary medicines
  • industrial chemicals
  • cosmetics
  • additives for human food and animal feed
  • biocides

The test facility must belong to the UK GLP compliance monitoring program, run by the UK GLP Monitoring Authority (UK GLPMA). The program is only open to facilities in the UK.

Test facilities that are contracted to work on part of a larger regulatory study should also usually be members of the compliance program.

In this version, updates were made for current members of the UK GLP Compliance monitoring program and added section relating to stakeholder engagement meetings.

Read more online 



Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 15 November 2021 the FDA published the updated guidance for Commercial Manufactures, Clinical Laboratories and FDA staff.

FDA is issuing this guidance to help facilitate the availability of devices for use in transporting certain clinical specimens, including transport media that can be used to transport certain clinical specimens for use with molecular Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) assays or antigen-detection diagnostic SARS-CoV-2 assays (hereinafter collectively referred to as SARS-CoV-2 assays) for the duration of the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

Read more online 



Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
On 15 November 2021 the FDA published the updated guidance for Developers and FDA staff.

FDA is issuing this guidance to provide FDA's enforcement policies regarding certain novel coronavirus (COVID-19) tests for the duration of the public health emergency. Rapid detection of COVID-19 cases in the United States requires wide availability of testing to control this rapidly spreading, severe illness. This document supersedes "Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff" issued May 11, 2020.

The policies in this guidance are intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act). FDA continues to assess the evolving situation and intends to update this guidance as appropriate.

Read more online 



Common Application Form for Clinical Research with Human Cells Genetically Modified
On 6 November 2021 the European Commission published the updated version of the common application form for clinical research with human cells genetically modified.

This application form can only be used for:

  • human cells genetically modified by means of retro/lentiviral vectors, including genome edited cells, in cases where the applicant demonstrates that:

(1) there is no risk of formation of replication competent virus, and (2) residual infectious retro/lentiviral vector particles have been reduced to negligible concentrations in the finished product, or there is negligible risk associated with the presence of residual infectious viral vector particles in the finished product;

  • human cells genetically modified by means of adeno-associated viral vectors, including genome edited cells, in cases where the applicant demonstrates that there is no risk of formation of replication competent virus; and
  • human cells genetically modified without viral vectors, including genome edited cells.

This application form can be used for submissions in the following jurisdictions: Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Portugal, Romania, Spain, Sweden, and Norway.

The application form must be accompanied by the SNIF (summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market) in the case of submissions that are made under Directive 2001/18/EC.

Read the pdf 



Good Practice on the Assessment of GMO-Related Aspects in the Context of Clinical Trials with Human Cells Genetically Modified
On 6 November 2021 the European Commission updated the guidance, version 5.

Clinical trials conducted in the EU with investigational medicinal products that contain or consist of genetically modified organisms ("GMOs") must comply with the legislation governing the authorization of clinical trials. The authorization procedure under the clinical trials framework aims to ensure the rights, safety, dignity and well-being of those individuals that take part in a clinical trial as well as the reliability and robustness of the data generated.

Clinical trials with medicinal products that contain or consist of GMOs must also comply with applicable requirements under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms ("deliberate release framework") and/or under Directive 2009/41/EC on the contained use of genetically modified micro-organisms ("contained use framework"). The GMO regulatory framework aims to ensure a high level of protection for human health and the environment.

Read the pdf 



Content of Premarket Submissions for Device Software Functions
On 4 November 2021 the FDA published the draft guidance for Industry and FDA staff. Comments may be submitted by 2 February 2022.

This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for FDA's evaluation of the safety and effectiveness of device software functions, which are functions that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The recommendations in this guidance document pertain to device software functions, including software in a medical device (SiMD) and software as a medical device (SaMD). When final, this document will replace FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005, and it will update FDA's thinking related to the documentation FDA recommends sponsors include for the review of device software functions in premarket submissions.

Read more online 



Position Paper by Swissmedic and Swissethics on Decentralized Clinical Trials (DCTs) with Medicinal Products
On 1 November 2021 the Swissmedic issued the updated guidance on DCTs.

The development of novel technologies and digitalization in the field of therapeutic products offers new opportunities. Through the use of these technologies in clinical trials, it is possible that study visits do not always have to be carried out in the hospital, but can also take place at home. In this context, innovative technologies allow health-related data to be digitally recorded and transmitted via devices worn on the body. These special features and other aspects play an essential role in so-called decentralized clinical trials (DCTs).

This development poses new challenges for all those involved. In a position paper, Swissmedic and Swissethics have summarized the main current challenges of DCTs with medicinal products and show under which conditions such clinical trials could be conducted in Switzerland. The paper is addressed to researchers and sponsors as well as all those interested in clinical research.

Read more online 

 

You receive this newsletter, because you have subscribed to it.
If you no longer want to receive this newsletter, you can easily leave the list at this Website. You can't view the images in this e-mail? Click here to open it in your browser.

Widler & Schiemann AG - Baarerstrasse 75 - CH 6300 Zug, Switzerland - VAT number: CHE-472.215.777 MWST - Public Limited Company according to Swiss Common Law - Managing Partner: Dr. Beat Widler, Dr. Peter Schiemann - +41 41 558 9193 - info@wsqms.com - http://www.wsqms.com