The newsletter provides a summary of recent news or key updates in the field of medical writing and relevant for our business activities. Information is selected from various sources such as the EMWA, AMWA, ICH, EMA, US FDA, and European Commission websites.
We hope you find the newsletter informative!
The 23rd session of the International Medical Device Regulators Forum (IMDRF) took place in Brussels on 27-28 March 2023. Presentations are available for download at https://imdrf2023.com/brussels/agenda.
Reform of EU Pharma Legislation
The European Commission (EC) adopted a proposal for a new Directive and Regulation, which revise and replace the existing general pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC) and the legislation on medicines for children (Regulation 1901/2006) and for rare diseases (Regulation 141/2000/EC). The aim is to modernize the pharmaceutical sector with a patient-centered approach, whilst fully supporting innovation and competitiveness, and to tackle antimicrobial resistance. It is also proposed to have Committee for Medicinal Products for Human Use (CHMP) opinion within 180 days (instead of 210 days) after receipt of a valid application (refer to https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en).
EU CTR Implementation
The PHUSE Data Transparancy Working Group published the learnings from Year 1 of the EU Clinical Trials Regulation (CTR) implementation (with a focus on transparency aspects). It includes information on metrics, guidance, deferral process and redaction of confidential commercial information (CCI), inadvertent publication of CCI, and the EU CTR Q&A document as well as some useful tips and an outlook for Year 2 (refer to https://advance.phuse.global/display/WEL/EU+CTR+Implementation).
The EMA ‘Guideline on computerised systems and electronic data in clinical trials’ replaces the ‘Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials’. The document includes general principles and definitions of key concepts and covers requirements and expectations for computerized systems, including validation, user management, security, and electronic data for the data life cycle. It indicates that the clinical trial protocols will need to specify the data capture methods. For more details, refer to https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-electronic-data-clinical-trials_en.pdf.
FDA Drugs & Biologics News
The US FDA published the final guidance document ‘A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers’, which provides recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results for investigational studies on human drugs, biologics, medical devices, and combinations of these products. It expands on and complements the guidance document ‘Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring’.
COVID-19-related FDA guidance documents issued since the start of the public health emergency (PHE) will either be discontinued or revised after 11 May 2023. Of note, the ‘FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency’ and ‘COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention’ are both intended to be retained with appropriate changes, while the ‘Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency’ will no longer be in effect after expiration of the PHE.
DARWIN EU® has completed its first 4 studies using real-world data from across Europe. The protocols and results of these studies are publicly available in the EU PAS Register. DARWIN EU® will be fully operational by 2025 and aims to deliver around 150 real-world evidence studies per year.
PHUSE has created a new Real World Evidence Working Group which aims to support, address, and answer questions around real world evidence. Current projects are ‘Quality and Reusability of Real-world Data’, ‘Real World Evidence Guidance’, and ‘Submitting Real-world Data’ (refer to https://advance.phuse.global/display/WEL/Real+World+Evidence).
At the 11th Global Summit on Regulatory Science, global regulators discussed how they are adapting to artificial intelligence (AI) technologies and advances in real-world data in drug and food safety. A summary of the conference is available at https://www.raps.org/news-and-articles/news-articles/2023/4/global-regulators-discuss-how-they-are-adapting-to.
Diversity in Clinical Trials
Enhancing diversity in clinical trial populations was discussed at the September 2022 RAPS Convergence. Topics included diversity, its importance in clinical trials, relevant regulatory policies, initiatives to encourage recruitment of diverse populations, and a diversity plan template for submission to regulators. A summary of the content presented at the meeting is available at https://www.raps.org/news-and-articles/news-articles/2022/12/enhancing-diversity-in-clinical-trial-populations.