The Paul-Ehrlich-Institut, Federal Institute of Vaccines and Biomedicines, actively participates in all regulatory activities of the European Medicines Agency (EMA) for the development, testing, and marketing authorisation of COVID-19 vaccines and biomedicines for the treatment of COVID-19. The challenges of the pandemic require further developments of procedures and the continued optimisation of processes. Intensive talks were held concerning this subject during this year’s virtual meeting with the German Medicines Manufacturers’ Association (Bundesverband der Arzneimittel-Hersteller, BAH) on 17 November 2020 as well as of the supply of influenza vaccines in the pandemic. Other subjects included the successful implementation of the medicines information system AmAnDa, developments in the use of real-world data (RWD) for marketing authorisation purposes, and how to strengthen the development and production of medicines in Europe.
"Especially in times of the SARS-CoV-2 pandemic, we have a particular obligation to review processes continuously for potentials of optimisation in order to increase efficiency and synergies. An example of a successful result is the rolling review procedures in authorising clinical trials and the rapid scientific advice procedure, coordinated by our innovation office,"
emphasised Professor Klaus Cichutek, president of the Paul-Ehrlich-Institut. "In the dialogue with the German Medicines Manufacturers’ Association, we receive important impulses concerning this"
. Representatives of the BAH stressed the importance of optimising interfaces of cooperation to achieve good results rapidly and effectively. Rapid solutions are especially required in developing and authorising vaccines and biomedicines against COVID-19 – without sacrificing efficacy and safety.
In this context, scientific advice talks represent an important interface for pharmaceutical companies. These have increased significantly. More than 30 talks have taken place since January 2020 for vaccines alone. Another form of meeting was well received as part of a joint discussion (SNSA – Simultaneous national scientific advice): The Bi-national Scientific Advice held by medicines agencies from two member states. The Paul-Ehrlich -Institut is participating in a pilot project that is currently being carried out. This project contributes to the European harmonisation of regulatory requirements. The BAH confirms the additional value gained with this option.
Upon request by the BAH, the Paul-Ehrlich-Institut confirms that it is already preparing for batch release testing of several COVID-19 vaccine products at this stage to become available as Official Medical Control Laboratory (OMCL) for Europe after the vaccines have obtained the marketing authorisation.
The Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) has procured additional influenza vaccine doses, thus increasing the influenza vaccination rate significantly. However, the demand for these vaccinations has increased strongly due to the COVID-19 pandemic. In this context, it is important to note the current vaccination recommendation by the Standing Vaccination Committee (Ständige Impfkomission, STIKO), for risk groups and elderly persons to supply this population group with a sufficient amount of vaccines. The Paul-Ehrlich-Institut records notifications on supply shortages to show potential bottlenecks and as data base for a further improvement of the vaccine distribution at the beginning of the influenza vaccination season.
A major digital project has been completed: With AmAnDa, the medicines information system AMIS has been replaced successfully. Subordinated applications are currently still in the process of being implemented, including the portal for reporting supply shortages. AmAnDa provides Germany with a tool enabling the country to harmonise data between the EMA and national systems. The Paul-Ehrlich-Institut is operatively involved both in relevant sub-projects and – at a control level – in the Change Management Board (CMB) of PharmNet.Bund.
Clinical studies only reflect part of the medicines applications. For this reason, experts increasingly discuss the use of data from health care, so-called real-world data (RWD) that provide a better picture of every-day use. To derive real-world evidence (RWE), thus to generate significant results, however, is not quite so simple. The EMA has already started a critical evaluation of the additional contribution by RWD and RWE in marketing authorisation procedures. Upon an enquiry by the BAH, the Paul-Ehrlich-Institut declared: A prerequisite for the use of RWD is the sufficient quality of these data.
The European Commission plans to strengthen the production of medicines in Europe. Being a reliable, strong, and agile medicines authority, the Paul-Ehrlich-Institut is a favourable location factor. With its work in the national council for supply shortages, it supports endeavours to secure supply chains, among other things, through the manufacture of medicines in the EU.
Updated: 18.11.2020
