Europe paves the way for you to obtain approval for your clinical trial more quickly. Picture by FGK with help of AI
HOW GERMANY IS BOOSTING CLINICAL RESEARCH: PART 2 - APPROVALS UNDER CLINICAL TRIAL REGULATION
Author: Ariane Helfrich, PhD
Since 2023, pharmaceutical companies have invested more than seven billion euros in Germany. The pharmaceutical industry is increasingly important for the German government. Many pharmaceutical companies also consider Germany one of the most important locations for clinical trials, and German research facilities continue to attract high-ranking foreign scientists¹.
To pave the way for accelerated clinical trial initiation, the submission, assessment and monitoring processes for clinical trials in the EU have been harmonized through the Clinical Trial Regulation as of January 31st 2022, using the Clinical Trials Information System (CTIS) deployed by EMA. This regulation has already been successful, with average reduction of 25 days in approval timelines across member states².
The Regulation (EU) No. 536/2014 (CTR) has significantly changed the approval process for clinical trials. In the past, sponsors had to submit a separate application for clinical trials in each European country to the national authorities and ethics committees paper-based, which was laborious and time-consuming. Nowadays, the complete digitalization of the application and authorization procedure accelerates approval time. This strengthens Europe’s position as an attractive location for conducting clinical trials, which also benefits Germany. Sponsors can obtain authorization in up to 30 EU and EEA countries with a single application. If the application is complete and valid, regulatory decisions can be made within 60 days. The assessment of dossiers for multinational clinical trials is conducted in parallel in all Member States Concerned (MSC) where the clinical trial should be initiated. A Reporting Member State (RMS) is defined among the participating Member States for coordination and procedural management. The sponsor can propose a Member State to be the RMS from among all the Member States involved for an application for authorization. The final decision is made on the available capacities and previous utilization among the involved Member States. The RMS coordinates the procedure, harmonizes possible objections and queries and is responsible for preparing the general part (Part I) of the assessment report. Part I includes the trial protocol, investigator’s brochure, investigational medicinal product dossier, auxiliary medicinal products and if applicable, e.g., paediatric investigation plan. Those elements and documents of a clinical trial that concern only national issues are dealt with in Part II of the assessment report. Part II includes, e.g., regulations on compensation and also the requirements for the experience and qualifications of investigators in a clinical trial. The evaluation of Part I and Part II of the application can be started simultaneously³.
If a sponsor is planning a mononational trial in Germany, an even shortened processing period can be expected, as the new German Medical Research Act (MFG) has established shortened processing times: Initial applications for mononational clinical trials can be assessed within 26 days after successful validation. If the application has no deficiencies, a positive decision can be made within 31 days. To drive innovation in the healthcare sector more efficiently, ethics committees and the two federal authorities – the Paul Ehrlich Institute (PEI) and the Federal Institute for Drugs and Medical Devices (BfARM) – also guarantee shortened deadlines for the processing of change notifications for mononational clinical trials, meaning that a decision is made no later than 24 days after successful validation4.
Initiating clinical trials without unnecessary delays is the goal of any biotechnology or pharmaceutical company. This key factor is a top priority at FGK. In order to make the approval process as efficiently and successful as possible, FGK starts collecting relevant documentation for submission as soon as a site has been selected by the sponsor. FGK already ensures that the site has the appropriate documentation within the feasibility process. In addition, FGK handles the application process on behalf of the sponsor and ensures that response timelines are met so that clinical trials can start as quickly as possible.