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TOPRA 2019: Technology poses challenges to the regulatory world – patient involvement is pursued

Do the long regulatory approval processes for new medicinal products put European patients in an inferior position compared to patients in other parts of the world? And when will the pilot for electronic product information be launched? These were the topics in the TOPRA symposium held in Dublin this year.

Main themes included:

1. Technological development poses challenges, but it also opens opportunities for new types of medicines. Is Europe prepared to assess medicines based on new technologies or novel innovations, or different types of study data (RWE and complex clinical studies)? Horizon Scanning procedures give the authorities a heads-up on future marketing authorisation applications. This gives an opportunity to consider whether the authorities have the necessary knowledge to assess such products and whether new guidelines or even amendments to the legislation are necessary. It currently takes significantly longer in Europe to obtain a new marketing authorisation than in the USA and Japan. Does this trend reduce interest in Europe when new marketing authorisation applications are planned?

2. Electronic Product Information (ePI) is again one step closer. EMA’s draft has been open for public opinions and feedback has now been received. Electronic properties of product information are positively welcomed, but it has been expressed that the contents of product information should also be developed to improve readability and usability of the information content. Pilot will hopefully be launched soon in some EU countries to mark the start of the journey towards larger scale use of electronic product information.

3. Closer patient involvement is desirable in various marketing authorisation-related processes. Patients’ views play an important role in decision-making. In recent years, EMA has organised two public hearing sessions as part of their drug safety assessment. Patients’ views had a stronger impact on the final outcome of the processes than was originally anticipated. Patient involvement is also wanted in the activities at EMA’s scientific groups, scientific information as well as in the assessment of therapeutic and economic value of medicines (Health Technology Assessment, HTA). Patient involvement increases trust in authority processes and improves transparency.

DRA Consulting took part in the TOPRA symposium both with their stand at the exhibition and also by attending the symposium’s presentation sessions.

Read more about the electronic Product Information: What if you could read a package leaflet without a magnifying glass?