November 2021: European Database on Medical Devices (Eudamed) Update

European Commission updated regarding, Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed)posted in the Official Journal of the European Union, on November 30, 2021:

The commission presents eleven articles that explain in detail regarding setting up, accessibility, functional rules, maintaining and managing Eudamed along with different definitions that apply to this regulation. It is mentioned in Article 2 that Eudamed would provide access to authorized users via ‘a restricted website’ and for non-identified users via ‘a public website’.

According to Article 3, to gain access to the restricted website a natural person needs to create an account on the Commission authentication service from where the Commission would register the competent authorities and the authorities responsible for the notified bodies and grant access to the first natural person on their behalf. For other entities to be registered in Eudamed a natural person acting on behalf of the prospective actor shall submit an actor registration request, via the restricted website which would then be approved by the national competent authority.

It is also mentioned in Article 9, that the Commission would provide a website for testing and training to the respective actor website. It would be mandatory for the actor to make at least one successful attempt of data submission using the testing website. The Commission also clarified that the data entered in the testing website would be considered fictitious and would not be available for the public. Concerned actors would be notified in advance via Eudamed of any changes and the period of availability on the testing website.

According to article 12, this regulation will come into force on the twentieth day following its publication in the Official Journal of the European Union and would directly be applicable in all Member States.

For more information, please click here.

November 2021: Transparency Scenario in Europe, United States and Canada

An article, Comparing regulatory transparency in Europe, United States and Canada, was published on TranspariMed on November 02, 2021.

This article, provides a comprehensive overview of the key laws and policies governing disclosure of data by major medicine regulators namely European Medicines Agency, the US Food and Drug Administration, and Health Canada. It also compares the data access provided to certain transparency documents by the regulators. This article was originally published by Cambridge university – Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration

According to the article, the three major medicines regulators are providing more access to key data than ever before. The study focuses on Clinical Study Reports, highly detailed documents that contain important information on the conduct and outcomes of clinical trials that cannot be found elsewhere, but also covers Individual Patient Data plus other types of data and documentation.

The key findings of the article are:

CLINICAL STUDY REPORTS

  • Redactions – The three regulators make only “minimal” redactions to Clinical Study Reports (CSRs) to remove commercially confidential information and data that may endanger patients’ anonymity. Those redactions “generally did not hamper the interpretation of evidence”.
  • Proactive disclosure – Only Health Canada and the European Medicines Agency proactively disclose new CSRs. While the Canadian regulator makes CSRs fully public, the European regulator places restrictions on who can access them, and how. The US Food and Drug Administration has yet to start proactively disclosing CSRs.
  • Reactive disclosure – All three agencies have mechanisms that allow researchers to gain access to older CSRs and other regulatory data upon request. Health Canada provides CSRs far faster and in a more accessible format than the other two regulators do.

INDIVIDUAL PATIENT DATA

Access to Individual Patient Data – Access to IPD via regulators is still impossible in practice. Only the US Food and Drug Administration releases IPD on request, but it when does so, it redacts the data so heavily that they are useless. The European Medicines Agency has formally committed to making IPD accessible in future, but this is not likely to happen any time soon. Health Canada does not have an IPD sharing policy.

ACCESS TO OTHER TYPES OF DATA

The three regulators differ widely in which other types of data they would release.

The article concluded that regulatory data pertinent to public health and clinical medicine, that were used to support the approval of medicines and medical devices are now available proactively or in response to information requests. Over the next decade, regulatory agencies should make Individual patient data available, and additional resources might be needed to ensure the long-term viability of regulatory data sharing programs and to encourage researchers to take advantage of the data that is — for now — more available than ever before.

More information can be found here.

October 2021: CTIS Update

European Medicines Agency (EMA) updated the page Clinical Trials Information System: training and support, on October 15, 2021, by adding reference material for clinical trial sponsors:

EMA made available reference materials that assist sponsors in using CTIS. It guides sponsors on how to create a user account, roles, responsibilities, user roles within CTIS, data fields to fill in CTIS while submitting and managing a clinical trial application.

Recently added reference material includes Principles for Sponsor organisation modelling for CTIS (v.1) and CTIS User Personas (updated).

For more information, please click here.

October 2021: EU PAS Webinar Update

The European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) will hold its virtual annual plenary meeting on 18 November 2021. Registration is open to ENCePP Partners (centres and networks) until 26 October 2021.

The event is for ENCePP Partners only, registration from other individuals will not be accepted.

Along with other objectives of the meet, following are the transparency objectives to be discussed:

  • To update on the work programme of the HMA-EMA Big Data Task Force and discuss the interface with ENCePP activities. Topics for discussion include the creation of curricula in Data Science, Pharmacoepidemiology and Biostatistics, the upgrading of the EU PAS Register and ENCePP Resources Database, an update on the Real-World Interrogation Network in the European Union (DARWIN EU) and the pilots for data analytics with EMA committees
  • To discuss the result of the surveys and agree on the amendments needed for the metadata and functionalities of the EU PAS Register and ENCePP Resources Database

The WebEx joining instructions will be sent to those ENCePP members who have registered via the registration form.

Related documents: 1. Registration Form   2. Meeting agenda

Additional details can be found here.

October 2021: European Union CTIS Go-live Planning

On 08 October 2021, EMA published a Go-Live plan for European Union CTIS system. On 21 April 2021, following an independent successful audit of CTIS, the EMA’s Management Board confirmed that CTIS is fully functional and meets the agreed functional specifications. The European Commission subsequently issued a Commission Decision which specifies that the entry into application of the CTR and hence the go-live date for the CTIS will be on 31 January 2022.

This CTIS Go-Live Plan provides an overview of the final remaining activities with the aim to:

  • Address the functional and non-functional areas as set out in the CTIS Project Release Plan for go-live
  • Prioritise the development of the sponsor workspace, followed by the authorities workspace and the public portal
  • Set up of a dedicated EMA Service Desk
  • Address operational and procedural aspects in relation to CTIS and supporting systems
  • Prepare extended stakeholder training
  • Support change management
  • Prepare for the initial scope of safety reporting and monitoring in clinical trials

A dedicated training environment will be made available for use by Member States and sponsors. A phased rollout schedule and controlled access based on needs and European Union Clinical Trials Information System CTIS: Go-live Planning. Access will first be provided to Master Trainers enabling them to train users within their organizations. The rollout is foreseen first for Member State Master Trainers mid-October 2021, followed by providing access to Sponsor Master Trainers from mid-November 2021 and thereafter additional Member States and sponsor users in subsequent batches.

October 2021: Highlights of Management Board Meeting

The Management Board heard an update on recent activities in response to the pandemic. The Board was updated on the status of the Agency’s ongoing COVID-19 lessons learned exercise. As part of this exercise, some of the measures and actions taken by EMA and the network in response to the pandemic are being discussed and reflected upon across a number of areas. Over the next few months, the Agency will discuss its findings and recommendations with the network in collaboration with the Heads of Medicines Agencies (HMA). The Board will be updated in December.

Face-to-face scientific committee meetings will be relaunched from the end of October, as a pilot, alternating on-site with remote meetings on a monthly basis.

Mid-year report 2021 adopted

The Agency’s report of activities in the first half of 2021 shows that requests for scientific advice for human medicines increased in the first six months of 2021 compared to the same period in 2020 predominantly due to many developers seeking advice for their COVID-19 vaccines and treatments. EMA received 46 requests for advanced therapy medicinal product (ATMP) classification in the first six months of 2021. Significant efforts were devoted to tackling vaccine hesitancy in the first half of 2021, including extensive public communication, webinars, and information on the EMA website on COVID-19 vaccines. The mid-year report will be published on the EMA website shortly.

Progress on EU IT systems required by the Clinical Trial Regulation

The Clinical Trial Regulation will come into application and the Clinical Trial Information System (CTIS) will go live on 31 January 2022. The Board noted the progress in the development and preparations for ‘go-live’ of CTIS and the CTIS global go-live plan. The CTIS functionalities, agreed for the go-live release, have been delivered and the focus is now on stabilising the system. EMA is providing tools and support to Member States and sponsors, and their staff, to facilitate preparations for go-live. CTIS is the cornerstone for application of the CTR. Clinical research and patient health in the EU will benefit from the streamlined regulatory processes that the Regulation and CTIS will bring.

October 2021: Clinical Trial Transparency at European Universities – A TranspariMED Report

The article, Most major European research institutions now uploading missing clinical trial results, was published on TranspariMed on October 06, 2021.

This article provides insights on a new report, ‘Clinical trial transparency at European universities’ by Cochrane Austria, Health Action International, and TranspariMED. It provides in detail the clinical trial results reported and missing, the number of results submitted, and the percentage of due results reported by different European institutions.

It was found that out of 26 institutions, 21 are now working on uploading the missing results. Overall, 28% of due trial results have by now been reported.

It has also mentioned the European countries that are still lagging and have made no progress in terms of submission of results. It proffers that only five institutions located in Italy and the Netherlands are not making any progress yet. The names of these institutes are presented in the article.

There are efforts underway to improve trial reporting at the European level, however, decisions on when and how to fine institutions that continue to break the law will be taken at the national level at the end of January 2022.

For more information, please click here.

October 2021: EU CTIS Webinar Update

European Medicines Agency updated the page Clinical Trials Information System- Webinar for small and medium-sized enterprises (SMEs) and academia over the What’s New Section on October 06, 2021:

It was notified in the update that registration for the webinar will be by invitation only and will be limited to SMEs registered with EMA, academia, and representatives of stakeholder organisations. Only the participants who have registered for the webinar will be able to attend the same.

However, a video recording of the meeting will be published on the EMA website after the event.

For more information, please click here.

 

October 2021: EU Update-Good Lay Summary Practice Guidance

European Commission uploaded Good Lay Summary Practice Guidance document on October 04, 2021:

According to the Regulation (EU) No. 536/2014, Article 371 “EU CTR”, submission of lay summary that is understandable to lay persons is mandatory for each and every pharmaceutical clinical trial that goes into EU database.

This guidance document proffers detailed recommendations for pre-eminent practices of planning, preparation, translation, and dissemination of high-quality lay language summaries of clinical trial results with medicinal products. It is divided into two parts, Part 1-GLSP Quick Guide and Part 2-GLSP handbook, respectively. The GLSP Quick Guide provides an abstract that contains the key aspects of the recommendations provided in the Handbook.

For more information, please click here.

 

 

September 2021: EMA Update

European Medicines Agency’s (EMA) published a Privacy Statement for the clinical data publication website on 28th September 2021.

EMA publishes clinical data on their website in accordance with the Agency’s policy (Policy 0070) on the publication of clinical data for medicinal products for human use.

This privacy statement explains the most essential details of the processing of personal data by EMA in the context of the user registration, access, and activity on the clinical data publication website. It also explains the reason for the processing, the way of collecting, handling, and ensuring protection of all personal data provided, how that information is used, and what rights may be exercised in relation to your data and how.

This privacy statement provides a detailed explanation on the following:

  • Who is responsible for processing the data?
  • Purpose of this data processing
  • Timeline of data retention by EMA
  • Access and disclosure of the information
  • Data protection rights
  • Resources (email and website) in case of any questions or complaints regarding data processing

For more details, please refer to European Medicines Agency’s Privacy Statement.