Clinical Trials for Medicinal Products
To obtain marketing authorization for new medicinal products, clinical trials must demonstrate efficacy and confirm safety and tolerability. During a clinical trial, investigational medicinal products (IMPs) — whether active (verum) or inactive (placebo) — must meet the same quality standards as authorized medicines.
Clinical trials are conducted in compliance with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) requirements. A GCP-compliant quality management system ensures that all ethical and legal requirements are met and that the trial results are reliable. The GMP-compliant manufacturing of IMPs is intended to ensure the safety of the participant and that the study results are not compromised by poor quality, safety, or efficacy due to improper production.
Diapharm advises and supports pharmaceutical companies on GMP compliance for investigational medicinal products. Diapharm’s Qualified Persons (QPs) are well-versed in the requirements of Annex 16, EU Regulation 2017/1569, and Guideline C(2017)8179, and can assume responsibility as external QPs within clients’ quality management systems.
Alternatively, clients can leverage Diapharm’s existing infrastructure to perform batch certification under Diapharm’s manufacturing and import authorization.
The regulatory environment for conducting clinical trials in European Union (EU) has changed significantly since February 2022. The regulation (EU) No. 536/2014 on clinical trials of medicinal products for human use, also known as the Clinical Trials Regulation (CTR), which came into force on January 31, 2022, brought about the harmonization and standardization of submission, assessment, and monitoring processes. For this purpose, a Clinical Trials Information System (CTIS) was established, serving as a central information source for clinical trial sponsors, supervisory authorities of all EU Member States, and the public alike. Before a clinical trial is even conducted, the sponsor must already provide relevant information and documents via the CTIS during the application process. In this way, a repository of diverse information develops over the lifecycle of a clinical trial. Since the CTIS also includes a publicly accessible area, transparency regarding ongoing and completed clinical trials — as well as clinical research in general — is increased, which can contribute to improved patient safety.
A well-designed study plan is the key building block for the success of a clinical trial. The study protocol, also known as the Clinical Trial Study Protocol, outlines in detail the objectives of the clinical trial, its organization and structure, the hypotheses to be tested, the methodology, and the planned data analysis. It defines the inclusion and exclusion criteria for participants and specifies how data will be collected and statistically analyzed. A carefully prepared study protocol ensures that the clinical trial is scientifically sound and that the results are reliable and reproducible.
Products used in clinical trials are referred to as investigational medicinal products (IMPs). IMPs are used to investigate efficacy, safety, and tolerability, and are administered to participants as part of a clinical trial. Special attention is given to the scientific comparison of an active substance (verum) with a placebo and/or other established treatment strategies. Randomized controlled clinical trials (RCTs) are considered the gold standard in clinical research.
The Investigational Medicinal Product Dossier (IMPD) is a comprehensive regulatory document that contains all necessary information about the investigational product. This includes details on the chemical and pharmaceutical quality, preclinical and clinical study results, as well as information on the manufacturing and quality control of the investigational product. The IMPD is a central component of the application materials for a clinical trial. Before the start of a clinical trial, the IMPD must be reviewed and approved by the relevant authorities. It plays a crucial role in ensuring patient safety.
Effective quality management plays a critical role in the success of clinical trials. It includes the implementation of quality-related processes and procedures that ensure all aspects of the clinical trial comply with applicable regulatory requirements. Thorough risk assessment helps to identify potential issues early and to take appropriate measures to minimize risks. Both contribute to maintaining the integrity of the clinical trial and safeguarding participant safety.
The manufacturing of investigational medicinal products generally follows the same quality standards as those applied to the production of approved finished pharmaceuticals. The manufacturing process for investigational products must also ensure consistent pharmaceutical quality. As a result, investigational medicinal products meet the highest quality standards as defined in the EU GMP guidelines. This is the only way to ensure that the use of investigational products during a clinical trial is sufficiently safe for participants and yields valid data on efficacy, safety, and tolerability.
The Qualified Person (QP) ensures that all regulatory requirements are met and verifies that the manufacturing and testing of each batch of an investigational medicinal product have been carried out in accordance with predefined acceptance criteria. Each batch of an investigational product is ultimately certified by the QP. This certification confirms that the batch has been manufactured in compliance with current GMP requirements and in accordance with the applicable IMPD. Only with this certification may a batch of an investigational medicinal product be used in a clinical trial within the EU.
