REGULATORY PUBLIC DISCLOSURE (RPD) - September

Medicines and Vaccines

EMA Publish COVID-19 Products’ Clinical Data 

EMA has published the clinical data supporting the renewal of Veklury's authorisation, in line with the exceptional measures that the Agency has implemented to maximise the transparency of its regulatory activities on COVID-19 medicines.

The clinical data underpinning the conditional marketing authorisation of the four COVID-19 vaccines approved in the EU are also available on EMA's clinical data website.

UK’s IRAS System Is Live

The MHRA combined review of Clinical Trials of Investigational Medicinal Products, or “CTIMPs” now has the systems functionality to support it, providing end-to-end lifecycle management through the Integrated Research Application System (IRAS). From 31 August, trial sponsors can manage their complete trial lifecycle via combined review using IRAS – from initial application through to amendments, safety reporting, end of trial notification and submission of summary results. This is effectively the UK’s mirror to the EU’s CTIS.

The UK’s Health Research Authority (HRA) published their final report requirements on 15 Sep 2021. The Final Report should be submitted within 12 months of the declaration of the end of study. The lay summary of results provided in this form will be published alongside the research summary record on the Research Summaries section of the HRA website. The HRA may also publish aggregate data collected from the Final Reports on the HRA website, as part of their annual research transparency reporting. This will not contain any personally identifiable information.

UK’s MHRA Issues Guidance on Access to Electronic Health Records in Clinical Trials

This guidance is for Sponsors, Contract Research Organisations (CROs) and investigator sites when considering management of personal data processed in relation to research.

Agencies Update COVID Guidance

FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency is updated (30 August 2021).

MHRA updated their COVID Guidance on 08 September 2021.

FDA Issue 3rd Notice of Noncompliance

The FDA continues to follow-up with Sponsors who are not submitting clinical trial results to clinicaltrials.gov by issuing a third letter of non-compliance to Case Western Reserve University for failing to submit results for a study (NCT03052816). The FDA acknowledged that the responsible party was ‘… very busy with the “Covid surge” and were short staffed.’ However, the letter goes on to say ‘Although we recognize the unique circumstances that the pandemic presents, we believe we have provided you ample opportunity to submit the required results information.’

As the FDA continues to publicly follow-up on private correspondence sent to Sponsors in 2020 alerting them to potential noncompliance with FDAAA, it is important for responsible parties to ensure their contact details are up to date in the ClinicalTrials.gov Protocol Registration and Results System (PRS). Pre-Notice Letters will be sent by FDA and will include an FDA contact to whom a response may be submitted and who can address any questions or concerns of the responsible party/submitter.

Transparency and Disclosure Publications and Resources

1. Thanks to colleagues for sharing the following global resources which facilitate geographical searches on privacy and disclosure regulations/guidance.

a is broad and general; b and c are integrated into a larger regulatory intelligence system; and d is a new tool developed by a disclosure-specific vendor.

a. Free generalised information on data protection is hosted by DLA piper.
b. Tarius hosts a pay platform for clinical trials disclosure that provides an overview of each country, and has a useful search function
c. Xogene Environmental Monitoring and PHUSE provide a free searchable clinical trials disclosure portal – the joint PHUSE-Xogene project
d. Cortellis Regulatory Intelligence

2. Open Pharma recommendations for plain language summaries are now available.

Coalition Calls for Increased Transparency in EU Clinical Trials

This open access letter from 28 heath and patient groups call for more clinical trial transparency in Europe.

"To avoid unnecessary duplications and to accelerate the development of new therapies and vaccines during a public health emergency, it is crucial that information on clinical trials is made available in a timely, user-friendly, and complete manner as proposed by the European Parliament.”

“The proposed amendment ensures that study protocols, summary results, clinical data submitted in support of a marketing application, and the eventual approval decision, are published in a timely manner and with more details than during normal times. We support this call and believe this should also be part of a wider effort outside of public health emergencies.”

“Looking ahead, we call … [to] ensure that any Clinical Trials Information System (CTIS) monitoring data capturing stakeholders’ performance is made publicly available in full and on an ongoing basis through the public CTIS interface. This will facilitate public accountability and translate into greater compliance.”

Read this TranspariMED article about it for further information.

Defending the Role of Medical Writing Professionals

This August 2021 JAMA publication – submitted on behalf of EMWA, AMWA and ISMPP - ably defends the medical writing professional role in the industry following unsubstantiated negative statements made in a recent publication in the same journal.

Continuing Professional Development Resources

1. The FDA 11th Annual Global Summit on Regulatory Science will be held on
4 – 6 October 2021. The focus is on Real World Data and Artificial Intelligence. Register here for free.

2. This Regulatory Focus article titled ‘EMA goes all in on big data’ brings us up to date with the Agency’s Big Data efforts.

3. This White Paper ‘Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK’ is published in Clinical Pharmacology and Therapeutics. The paper provides “… the agencies’ perspectives on the challenges in ensuring data quality in novel clinical trial designs and the importance of the management and documentation of protocol deviations, sponsor oversight of clinical trials, and use of electronic source data, including electronic health records.”

4. The Good Clinical Trials Collaborative was set up to develop guidance to promote and enable good RCTs. The Collaborative has launched the draft guidance for public consultation, which will be running between 04 August and 15 September 2021. Have your say and shape the guidance.

5. WHO and ICMRA announce a joint statement on data transparency and integrity in which they urge the pharmaceutical industry to provide greater access to clinical data for all new medicines and vaccines, regardless of approval status. Read about it here in The Publication Plan.

Devices

With the application of the EU Medical Device Regulation (MDR) this year, we are seeing more guidance documents developed to facilitate its implementation. Below is a rundown of the key developments that impact transparency in the medical device industry.

Updates on Borderline Products

Borderline cases are those “where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not.” Borderline cases also cover devices whose risk classification is unclear. The EU released a manual on borderline products in 2019. The MDCG Borderline & Classification Working Group recently updated the Helsinki Procedure document which describes the decision making process and the exchange of information between medical device competent authorities on borderline and classification cases.

Updates on IVD Expert Panels

The expert panel in the field of in vitro diagnostic medical devices is now accepting submissions from notified bodies for the Performance Evaluation Consultation Procedure. The MDR (EU) 2017/745 (MDR) and IVDR (EU) 2017/746 require the European Commission to create expert panels to support the scientific assessment and advice in the field of medical devices and in vitro diagnostic medical devices. Members of the panel are strictly chosen for their expertise and absence of interests (financial and non-financial) that could affect their independence, impartiality and objectivity and their profiles are made public.

Coordinating Research and Evidence for Medical Devices (CORE-MD)

CORE–MD is a European Union Horizon 2020 project that runs from April 2021 until March 2024. Its ultimate goal is improved methods for clinical investigation and evaluation of high-risk medical devices. It reviews methods for evaluating high-risk medical devices, in order to translate expert evidence into advice for EU regulators and to recommend an appropriate balance between innovation, safety, and clinical effectiveness.

MHRA and Regulation of Medical Devices in the UK

UK’s MHRA has launched a 10-week public consultation on future of medical device regulation in the UK. Due to Brexit, the UK is not following the EU MDR. The consultation covers a broad range of regulatory issues, including clinical investigations, market authorisation, importation, distribution, post-market surveillance and transparency and the role of patients. 

EFPIA on Integral Drug-Device Combination Products

The European Federation of Pharmaceutical Industries and Associations (EFPIA) released this reflection paper on the marketing authorisation of drug-device combination products under the EU MDR. The paper recognises the overlap in responsibility and expectations by the competent authorities and notified bodies that can potentially lead to documentation duplication and conflicting opinion from these two separate review bodies. Proposals to streamline the process are provided.