Featured news that matters in medical writing and communications – April 2022

The newsletter provides a summary of recent news or key updates in the field of medical writing and relevant for our business activities.
We hope you find the newsletter informative!


EU CTR 536/2014 Q&A

A new version of the Questions and Answers Document – Regulation (EU) 536/2014 – Version 5 (January 2022) is available. The document provides general guidance on the implementation of the CTR and should be read in combination with the CTIS online training modules and more specific documents published on EudraLex Volume 10. (https://ec.europa.eu/health/medicinal-products/eudralex/eudralex-volume-10_en)


EMA News

The EMA initiated the establishment of the coordination centre for the Data Analysis and Real World Interrogation Network (DARWIN EU®) to provide timely and reliable evidence on the use, safety and effectiveness of medicines for human use, including vaccines, from real world healthcare databases across the EU. This will enable EMA and national competent authorities in the European Medicines Regulatory Network to use these data whenever needed throughout the lifecycle of a medicinal product. (https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu)


The EMA publishes newsletters to provide updates on various topics. The ‘CTIS Highlights’ newsletter has been renamed to ‘Clinical Trial Highlights’; it will continue to cover CTIS but will also include topics such as the business change program ACT EU. Two new newsletters are:

  • ‘CTIS Newsflash’, which contains short updates on system usage, key facts and figures, hints to help users with specific features and links to reference materials.
  • ‘Big Data Highlights’, published every 3 months, which provides an update on progress in implementing the workplan of the HMA-EMA Big Data Steering Group.


All EMA newsletters can be found at https://www.ema.europa.eu/en/news-events/publications/newsletters.

The EMA published the ICH E14/S7B ‘Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential – questions and answers’ developed by the ICH E14/S7B Experts to facilitate the implementation of the ICH E14 and S7B Guidelines.


FDA News

The US FDA recently released several final guidance documents:


  • Population Pharmacokinetics is intended to assist in the application of population pharmacokinetic (PK) analysis. Adequate population PK data collection and analyses submitted in marketing applications have in some cases alleviated the need for postmarketing requirements/commitments. It also outlines includes the recommended format and content of the Population PK report.
  • Patient-Focused Drug Development: Methods to Identify What Is Important to Patients (the second in a series of 4 patient-focused drug development guidance documents) describes how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.
  • Inclusion of Older Adults in Cancer Clinical Trials provides recommendations for including an adequate representation of older adults in cancer clinical trials to better enable evaluation of the benefit-risk profile of cancer drugs in this population. It emphasizes the particular importance of including adults over age 75 years in cancer clinical trials.
  • Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics provides recommendations regarding the design and conduct of clinical trials intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers. In general, the recommended Phase 2 dose should have been established for an investigational drug or drugs evaluated in a master protocol.
  • Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics provides advice regarding the design and conduct of first-in-human clinical trials using expansion cohorts. These designs employ multiple, concurrently accruing subject cohorts, where individual cohorts assess different aspects of the safety, pharmacokinetics, and antitumor activity of the drug product.


Medical Devices Information

The International Medical Device Regulators Forum (IMDRF) released an update to IMDRF Technical document on Terminologies for Categorized Adverse Event Reporting (AER) for Medical Devices: terms, terminology and codes. The new version includes updates to Annexes A to G which cover AE codes for medical device problems, investigations, medical components, and health effects. (https://www.imdrf.org/documents/terminologies-categorized-adverse-event-reporting-aer-terms-terminology-and-codes)


The EU Medical Device Coordinating Group (MDCG) has updated the MDCG 2019-9 Rev. 1 Summary of safety and clinical performance (SSCP): A guide for manufacturers and notified bodies. The SSCP (for implantable and class III devices, other than custom-made or investigational devices) is required under the medical device regulation to be publicly available in EUDAMED. Other recently released new and updated guidance documents can be found at https://ec.europa.eu/health/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_nl.


Sources: EMA, FDA and EMWA websites

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