Tests according to AMG

Drug trials are investigations into the quality, effectiveness and safety of medicinal products as part of the drug authorisation process.

It is a highly regulated, lengthy, risky and time-consuming process that requires precision and multidisciplinary professionalism.

In the EU, the scientific guidelines of the European Medicines Agency apply. In Germany, there are also the drug testing guidelines in accordance with the Medicinal Products Act. Since 2016, the Ordinance on the Application of the Medicinal Product Test Guidelines* (Arzneimittelprüfrichtlinien-Verordnung - AMPV) has made the application of the Medicinal Product Test Guidelines legally binding. When the EU regulation came into force on 31 January 2022 for Regulation (EU) 536/2014, the transition period of 3 years began.

Preclinical studies

The development of an effective and low-risk drug from discovery to market launch is a labour-intensive process lasting several years. It begins with preclinical tests in the laboratory in vitro and in vivo.

Once it has been proven that a substance is safe, the Common Technical Document (CTD) must be drawn up in accordance with the International Conference on Harmonisation (ICH). This is a mandatory step in the development process of a drug before a clinical study in humans can even begin. The CTD consists of 5 modules containing detailed information on the formulation and pharmaceutical quality through to the results of in vitro and in vivo efficacy tests, toxicity studies, pharmacokinetics, bioavailability and potential risks to the environment.

Only after the European Commission has approved the document can a Phase I clinical study under the German Medicines Act (AMG) begin.

Phases of clinical drug trials

Clinical investigations are divided into four (or five) phases (phase (0) I-IV) depending on the type of drug. The next (subsequent) phase of the clinical study cannot begin until the previous one has demonstrated the safety and effectiveness of the drug.

• Phase 0 Investigates drug safety in humans.
• Phase I Records the maximum safe dose of the investigational medicinal product in healthy people.
• Phase II Patients receive the investigational medicinal product for the first time (tests for safety and effectiveness).
• Phase III Compares the test drug with established standard treatment in patients.
• Phase IV Tests the effectiveness and safety over a long period of time in a large number of patients.

In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI) are responsible.

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