Posted on 25 Jul 2022

Regulatory News

Medicines and Vaccines
1. The International Council for Harmonisation (ICH) held a successful hybrid Meeting in Athens on 21 to 25 May 2022. Reports were received from all the ICH Working Groups on their activity status, a report from the MedDRA Management Committee, and updates on important ICH activities related to training and communication. A summary of the meeting is on the ICH Official website.
1. Clinical Trials Highlights Issue 9 (May 2022) is out now. 
2. An EMA CTIS webinar will take place on 01 July 2022, 09.30 to 13.30 CET. There is no need to register – the event will be broadcast live. The event will look back at six months of CTIS and will also look to the future.
EU Regulatory
1. A new Brookwood webinar is planned for 28 June 2022 at 13.00 UK time: ‘Overview and impact of ICH E8(R1) on clinical trials’.
2. The European Commission’s Q&A document on EU CTR 536/2014 is at Version 6.1, last updated in May 2022; there is a new Q&A on complex clinical trials; and a Q&A on the interface between the CTR and Regulation EU 2017/746 (which covers in vitro medical devices). All are available as ‘Latest updates’ at the bottom of this page.
3. Draft EMA Guidance titled “Guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial Information System (CTIS)” is open for public consultation until 08 September 2022.
4. A list of metadata for real-world data catalogues is published on the Big Data EMA webpage to help pharmaceutical companies and researchers to identify and use such data to investigate the use, safety and effectiveness of medicines.
5. Publicly available clinical data are published on EMA’s Clinical Data webpage for COVID vaccines Nuvaxovid, Spikevax, and Cominarty – all in June 2022.
6. The EMA and Health Canada co-chaired the latest global regulatory workshop on COVID-19 observational studies and real-world data on 20 May 2022 and discussed collaboration on observational research during the pandemic.
7. The EMA, EC, and HMA have jointly issued a Q&As document on conducting complex clinical trials  (CCTs) on 23 May 2022. It provides guidance to support sponsors, clinical trialists, and applicants regarding scientific aspects and the planning, set-up, submission for obtaining CT authorisation, conduct, reporting and transparency, analysis and interpretation of CCTs under the EU CTR, and as their use in submissions for marketing authorisation.
The UK and MHRA News
1. MHRA has joined three international partnerships to set global standards for medicines and medical devices regulation. The partnerships are with ICHIMDRF  and  MDIC.
2. The wide-reaching effect of the COVID-19 pandemic on healthcare resources has led the UK’s National Health Service (NHS) Health Research Authority (HRA) to ask sponsors and funders of research within the NHS to urgently review their study portfolios, with the aim to make changes or close ‘unviable’ studies in order to release resource and funding for other studies. The HRA has issued guidance on how to manage changes to studies, stop recruitment or close studies, with the necessary assessments of risk-benefit and ethics, and how to make the data available.
FDA Guidance and News
1. The FDA continues oversight of trials during the COVID-19 pandemic and has released the 2021 data of its annual inspection metrics for the compliance programs within the Bioresearch Monitoring (BIMO) program.
2. FDA will run two public meetings on patient-focused drug development (PFDD)  ‘Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials: Who to Ask and How to Ask ’ – dates 30 June and 25 July 2022.
3. A joint study published in Therapeutic Innovation & Regulatory Science on 24 May 2022, authored by representatives from the FDA and EMA, stresses the value of EU-US ongoing collaboration on GCP inspections. GCP inspection findings between the two agencies were comparable, supporting continued FDA‑EMA GCP collaboration.
Real-World Data
1. eHealth Network (a voluntary network set up under article 14 of Directive 2011/24/EU that provides a platform of Member States' competent authorities dealing with eHealth) released a “Guideline on the electronic exchange of health data under Cross-Border Directive 2011/24/EU ” in Jun 2022.
2. The Clinical Trials Transformation Initiative (CTTI) held a multi-stakeholder Expert Meeting on 11 May 2022 to discuss recommendations for embedding elements of clinical trials into routine care. More resources are expected to be released in late 2022.
Transparency and Disclosure Resources and News
1. In the previous CORE Reference News Summary of May 2022, we cited the TranspariMED article and report by Prescrire on the alleged decline in access to information on drug trials in Europe in recent years. As reported in an update to the TranspariMED article, EMA has pushed back against Prescrire's criticisms. EMA has also responded to articles on transparency published in the BMJ.
2. Issue 9 of EMA’s Clinical Trials Highlights newsletter reports that as of 30 April 2022, 56 clinical trial applications have been submitted for evaluation via CTIS. Four clinical trials are authorised and publicly viewable through the CTIS public search function.
3. Reminder of PHUSE’s Data Transparency Summer Event – 28-30 June 2022. Agenda here; register here.
4. Dormer et al. published an article on plain language summary “A practical ‘How-To’ Guide to plain language summaries (PLS) of peer-reviewed scientific publications: results of a multi-stakeholder initiative utilizing co-creation methodology”.
5. The CPDP2022 workshop "State-of-Play of De-Identification Techniques " took place in Belgium on 25 May 2022, and a recording of the workshop is available on YouTube.
Development Strategy News
1. This LinkedIn Group, ‘Protocol Development’, issues interesting articles on the topic. Issue 8 (27 May 2022)  includes links to several useful papers, for example, basket trials and platform design trials. Many more papers in this issue caught my eye, so I suggest you sign up to join the group to access all the materials in this issue and others.
2. The WHO published a draft resolution (proposed by Argentina, Peru, and the UK) ‘Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination ’. A call is made to strengthen national capabilities to comply with international standards of trial design and to strengthen policy frameworks. There is also the suggestion that publicly available protocol design critiques should be made available by regulators and other transparency initiatives.
News from Asia Regulators
1. The Drug Regulatory Authority of Pakistan (DRAP) has published the final guidelines on clinical trials applications for therapeutic goods in Pakistan, which provides advice on new applications for clinical trials, subsequent submissions, regulatory requirements, the procedure for submission, review, evaluation and approval of applications for the conduct of the clinical trial.
Medical Devices
Raquel Billiones kindly compiled the medical device information.
1. MCDG 2022-10 Q&As on the interface between EU CTR and IVDR issued on 25 May 2022
The Q&As aim to clarify certain interfaces between the CTR and the IVDR and to support the conduct of clinical trials using diagnostic assays, including combined trials for the development of companion diagnostics.
2. In Switzerland (26 May 2022), clinical trials with in vitro diagnostic medical devices will be regulated by the Ordinance on Clinical Trials with Medical Devices instead of the Ordinance on Clinical Trials. This came into effect concurrent with the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices in the EU (see next point).
3. European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a statement on the Regulation (EU) 2017/746 for in vitro diagnostics. The new regulation aims to ensure a high level of public and patient safety, but the EFPIA highlight that there are still some aspects of the use of these devices in clinical trials that have not been addressed.