Vaccines and therapeutic drugs were quickly made available throughout the ongoing pandemic. Effective and rapid drug development and authorisation also helps to further improve healthcare for the population outside of pandemics. The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, and the German Association of Research-Based Pharmaceutical Companies (Verband Forschender Arzneimittelhersteller e.V., vfa) discussed how innovation, agile processes, and regulatory changes are impacting the advancement and acceleration of processes on the path to safe and effective biomedicines at their annual meeting on 19 October 2022.
"Given the rapid pace of technological innovation and ever-evolving regulatory requirements, it is important for researchers and regulators to share their experiences and discuss new developments and technologies,"
said Professor Stefan Vieths, Vice President of the Paul-Ehrlich-Institut.
As was expected, most of the topics in the nearly four-hour meeting concerned approaches to further accelerate the development of innovative and urgently needed medicines. For example, the meeting participants discussed ways to make authorisation procedures even more dynamic in the future, while also taking into account the fact that a well-founded scientific evaluation of the safety, efficacy and quality of a drug requires comprehensive underlying data. The discussion centred on agile procedures, which allow new data to be continuously added and new or follow-up evaluations to be carried out as part of the authorisation process. Exchanges between drug developers and regulators regarding the possibilities of such agile procedures and potential changes to EU pharmaceutical legislation are important to better understand both parties’ respective needs and prevent information asymmetries.
The importance of data management for efficient processes in drug authorisation has already increased enormously in recent years and will play an even greater role in the future. Against this background, the participants discussed national, European and international initiatives for digitalisation. The Paul-Ehrlich-Institut is aware of the importance of the topic and supports initiatives on the part of the World Health Organization (WHO) and the International Coalition of Medicines Regulatory Agencies (ICMRA). It participates in all national and EU digitalisation initiatives.
The discussions also focused on the new requirements for clinical trials and the possibilities for drug developers to make use of scientific-regulatory advice from the Paul-Ehrlich-Institut as part of drug development or in the run-up to an authorisation process.
The great mutual interest in this now firmly established exchange of experience and information shows how important it is for all players in the field of drug development to be in dialogue - in the interest of safe, effective and high-quality medicines for the public.
Updated: 19.10.2022
