May 2022

Medicines and Vaccines

EMA Guidance and News

EMA have released ‘Key performance indicators (KPIs) to monitor the European clinical trials environment’ that includes metrics on the CTR and CTD from 31 Jan to 30 Apr 2022. 

European Health Data Space

The European Commission is proposing The European Health Data Space Regulation to set up a governance ecosystem for both primary and secondary use of health data. An open public consultation will ensue. This is one to keep an eye on, as it seems inevitable that it will impact clinical research data of the future.

FDA Guidance and News

1. Final FDA Guidance ‘Bioavailability Studies Submitted in NDAs or INDs — General Considerations Guidance for Industry ’ dated April 2022 is out now.

2. The FDA’s CDER and CBER invite you to the virtual 2022 Regulatory Education for Industry Annual Conference. The event will take place from 6 June through 10 June 2022. Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements. Registration and attendance are free. Register here ; agenda here.

Real World Data

Reuters Events are hosting a free real-world data (RWD) Webinar to help understand the nuances of the rare disease landscape, and overcome factors limiting data capture, data abundance and data robustness. Experts from Pfizer, Novartis, Alexion Pharma, Cegedim Health Data and UCB will discuss how pharma can effectively utilize anonymized RWD for rare diseases. The 1-hour webinar is live on 24 May 2022 or you may watch on-demand afterwards.

Transparency and Disclosure Resources and News

  1. This TranspariMED article ‘Access to information on drug trials in Europe is getting worse, new report warns’ describes a Prescrire report that shows a decline in recent years in access to information held by EMA on clinical trial results. Download the report here. 
  1. This TranspariMED article shows that ex-US institutions are at risk of FDA fines for unreported clinical trial results. 
  1. Real Life Sciences (RLS) have released resources to support process development around the EU CTR and CTIS on their website including a full-length webinar and accompanying slides on the EU CTR, along with case studies, the CTIS training guide and links to other relevant materials.

Development Strategy News

  1. Fletcher et al’s publication, “Marking 2‑Years of New Thinking in Clinical Trials: The Estimand Journey” presents a good summary on estimands and explains how an estimand framework relates to clinical aspects of study design. The section 'Implementing the Estimand Framework in Protocols' is useful for CSP authors, and highlights some challenges. The article is a good reflection of the point the industry has reached with estimand, and it highlights that there is still some way to go. 
  1. This National Academies of Sciences, Engineering and Medicine report highlights the persistent lack of diversity among participants in clinical trials as a critical issue that is harming both populations that have long been left out of pivotal medical studies and the entire biomedical research enterprise.

Medical Devices

Medical devices information is kindly compiled by Raquel Billiones.

MDCG 2022-6

The latest guidance released by the MDCG is on significant changes regarding the transitional provision under Article 110(3) of the IVDR (MDCG-2022-6). The IVDR 2017/746 comes into application on 26 May 2022. This guidance document is intended to provide clarification on the concept of ‘significant changes in the design and intended purpose’ under IVDR Article 110(3) with respect to the transition from the Directive to the IVDR.

Updates from IMDRF

The International Medical Device Regulators Forum (IMDRF) issued several technical documents this month:

Updates from the World Health Organization

The 2022 WHO Global Model Regulatory Framework for medical devices including IVDs (GMRF) is an update to the 2017 version and is open for public comments. The original framework was to support member states that have yet to develop and implement regulatory controls relating to medical devices.

Updates from TGA Australia

The Australia health authority Therapeutic Goods Administration issued an updated guidance on regulation of software based medical devices.

Updates from the Notified Bodies

Check out TüV-SüD’s white paper on Cybersecurity, Medical Devices and IEC 81001-5-1.

MDCG Updates

The EU Medical Device Coordination Group (MDCG) issued several guidance documents in preparation for the date of application of the In Vitro Diagnostic Regulation (IVDR 2017/746) on 26 May 2022.

MDCG 2022-9 SSP template

Under the IVDR, a Summary of Safety and Performance (SSP) is required for Class C and Class D in vitro diagnostic devices (IVDs) for better transparency. MDCG 2022-9 provides an SSP template for IVD manufacturers. The SSP comprise 2 parts, a summary for professional users and a summary for patients and lay audience. The SSCP is to be uploaded in the EUDAMED for public disclosure.

MDCG 2022-8 Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’

MDCG 2022-8 provides guidance on the applicability of the IVDR requirements to ‘legacy’ and ‘old’ IVDs.

MDCG 2022-7 Q A on the Unique Device Identification (UDI) system

The Unique Device Identification system (UDI system) established under the MDR 217/745 and IVDR 2017/746 are to be used for mainstream MDs and IVDs to facilitate product traceability. The MDCG 2022-7 Q&A provides further details to operators on the application and practical implementation of the UDI requirements.

MHRA Updates for clinical investigations for MDs and IVDs

The MHRA recently updated their guidance on clinical investigations for medical devices. The update adds information on “study deviations” and provides a protocol deviation tracker template in Excel format.

Back to News Summaries