Europe as a Centre for Regulatory Excellence – The journey

published 24 Dec 2019

Source: TOPRA Symposium – 30 Sep to 2-Oct 2019 – Dublin – HM1 Session report – Leslie Dowling, Managing Consultant at Real Regulatory (UK)

Authors: Leslie Dowling

Chair: Lorraine Nolan, Chief Executive, HPRA, Ireland


  • Anthony Humphreys, Head of Scientific Committees Regulatory Science Strategy, EMA
  • Pär Tellner, Director, Regulatory, Drug Development and Manufacturing, EFPIA
  • Florian Schmidt, Deputy Head of Unit B5, Directorate General Health and Food Safety (DG SANTE), European Commission
  • Greet Musch, General Director DG PRE authorisation, FAMHP, Belgium

Lorraine Nolan welcomed attendees to Dublin and introduced the session, asking attendees to answer a few questions using the mobile app, to show the demographics of the attendees (e.g., which area of regulatory affairs they work in and how many years of regulatory experience they have) and what the attendees saw as key developments going forward (real world evidence(RWE) and artificial intelligence (AI) were the top answers).

Pär Tellner gave the industry view regarding whether Europe is a centre for regulatory excellence. On the positive side, the EU review procedure is predictable with clear timelines; the EU Centralised Procedure (CP) system of having both a rapporteur and a co-rapporteur ensures continuity; the EU system is an example and inspiration for other regions, e.g., Eurasian Economic Union; and the EMA’s coordination role for joint HTA/regulator scientific advice (SA), Priority Medicines (PRIME) scheme and Regulatory Science Strategy to 2025 are great examples of regulatory excellence. However, there are also areas with potential for improvement: EU approval times are generally longer than for US and Japan; the perception amongst EFPIA companies is that the US FDA is more open to accepting data from complex clinical trials (CTs) and RWE (although no evidence that this is in fact true); there is insufficient consistency at all levels of the network, e.g., paediatrics; EMA SA timelines are too long at 4-6 months; and processes for drug-device combinations and biomarker validation need to be optimized. The risk is that new active substance submissions will be submitted first in US, Japan and China, with European submission only later in a second wave.

Representing the EMA, Anthony Humphries asked how can the EMA be future-proofed, and what should the agency be doing in the next 5 years? The EMA holds technology platform meetings with companies to find out what new technologies they are developing. EMA is trying to: foster innovation in CTs, e.g., methodological complexity, multiplicity and digital therapeutics; promote use of high quality real world data (RWD) with involvement of patients across the product life-cycle; encourage health technology assessment (HTA) preparedness for faster patient access; keep abreast of medical innovations in diagnosis, e.g., genomics and AI. The goal is to provide an environment that fosters innovation, not to set up hurdles, in order to ensure availability of safe and effective medicines.

Greet Musch provided a national competent authority (NCA) view, discussing the Heads of Medicines Agencies (HMA)-EMA regulatory framework common strategy, which focuses on four areas. First, innovation, which requires the medicines agencies to reach out to the medical technology sectors to develop a more holistic view of the different regulatory initiatives, e.g., interplays of CT Regulation with IVD Regulation; seek out critical expertise and focus on innovative CT designs. Second, availability/accessibility of medicines, which requires reaching out to HTA bodies, payers, health care providers and patient both from an early stage and during the product life-cycle; and enhancing international alignment. Third, use of data analytics and AI in decision making, with use of RWD/RWE and digitalization of CT and manufacturing processes. Fourth, sustainability and operational excellence of the regulatory network, with a leaner iterative process to enhance return on investment with innovation committees linking together existing groups, e.g., SAWP-CTFG-EUNetHTA, CTFG-PDCO; and development of NCAs as centres of excellence.

Florian Schmidt presented the European Commission view, admitting that there are challenges for the system now with new political leadership due in November 2019.  However, divergences are being addressed with medical devices being considered now also under the same DG with medicines and setting the dual priorities of supply of affordable medicines whilst still supporting innovation to keep the EU at the forefront of development.  Innovation is of no help if it doesn’t reach the patient, so access and availability are focus areas. The recent nitrosamines issue has raised the question of whether the EU quality system is strong enough, with more global diversity in supply introducing more risk. With the rise in ATMPs, drug/device combinations, use of AI in CTs and post-market, is the EU regulatory system still fit for purpose? These changes in paradigm must affect the regulatory framework.

During the panel discussion, the following key points emerged for future action to keep Europe a centre of regulatory excellence:

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