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France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first instance of recommendations released by

On March 28, 2019, the Council of Europe* issued a new Recommendation on the protection of health-related data.  The Recommendation calls on all Council of Europe member states to take steps to ensure that the principles for processing health-related data (in both the public and private sector) set out in the Appendix of the Recommendation

Following on from the Evidence Standards Framework for DHTs published in December 2018 (the Original Standards, as reported in our previous blog post, here), the UK’s National Institute for Health and Care Excellence (NICE) recently published a newly updated version of the standards (the Updated Standards, available here).

The

On 15 February 2019, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) published their Joint Big Data Taskforce’s summary report (available here) setting out recommendations for understanding the acceptability of evidence derived from ‘big data’ in support of the evaluation and supervision of medicines by regulators.

The Taskforce has sought to clarify the meaning of ‘big data’ within the medicines regulatory context, defining it within the report as: “extremely large datasets which may be complex, multi-dimensional, unstructured and heterogeneous, which are accumulating rapidly and which may be analysed computationally to reveal patterns, trends, and associations. In general big data sets require advanced or specialised methods to provide an answer within reliable constraints”.

The Taskforce was split into seven sub-groups, each focusing on different categories of datasets:

  1. Clinical trials and imaging;
  2. Observational (or ‘Real World’) data;
  3. Spontaneous adverse drug reports (ADR);
  4. Social media and mobile health;
  5. Genomics;
  6. Bioanalytical ‘omics (with a focus on proteomics); and
  7. Data analytics (this work is ongoing and cuts across the above six sub-groups; a further report is expected in Q1 2019).

The sub-groups were each asked, amongst other thing, to characterise their respective datasets; consider the specific areas where big data usability and applicability may add value; assess the existing competencies and expertise present across the European regulatory network regarding the analysis and interpretation of big data; and provide a list of recommendations and a ‘Big Data Roadmap’.


Continue Reading EMA-HMA joint taskforce publish report outlining recommendations for using ‘big data’ for medicines regulation

On 17 October, the UK Government’s Department of Health and Social Care (DHSC) published a policy paper entitled “The future of healthcare: our vision for digital, data and technology in health and care” (the Policy Paper). The Policy Paper outlines the DHSC’s vision to use technology across the health and

On 8 October, the European Medicines Agency (EMA) published a report (available here) setting out the progress it has made towards applying a common data model (CDM) in Europe. The EMA defines a CDM as “a mechanism by which raw data are standardized to a common structure, format and terminology independently from any particular study in order to allow a combined analysis across several databases/datasets”. The report follows an EMA-hosted workshop in December 2017 to examine the opportunities and challenges of developing a CDM.

The report acknowledges that the use of ‘Real World Data’ (RWD) (data relating to patient health status or delivery of health care data that is routinely collected from sources other than clinical trials) has become an increasingly common source of evidence to support drug development and regulatory decision making for human medical use in Europe. However, Europe currently has no pan-European data network, despite the wealth of data generated through various national healthcare systems that provide access for all. Many multi-database studies currently performed are typically slow and still allow for substantial variability in the conduct of studies. Further, there are a growing number of innovative products that no longer align with customary drug development pathways. This may create uncertainty in their data packages required for authorization, and subsequent tension between facilitating earlier access for patients with limited treatment options against the requirement for proactive robust pharmacovigilance of medicines for wider clinical use across the product life cycle (the existing EMA Patient Registry Initiative addresses this need in part).
Continue Reading EMA publishes “A Common Data Model for Europe? – Why? Which? How?” Workshop Report