According to §3 of the GCP regulation, a clinical investigational product is a dosage form of an active substance or placebo that is tested in a clinical trial on humans or used as a comparator preparation or used to produce certain reactions in humans.
Investigational product
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Investigational medicinal products may either not be authorised or may already be available in another pharmaceutical form (e.g. drops instead of tablets). They may already be approved for other indications or may be used to compare new substances. The use of investigational medicinal products is defined in Directive 2001/20/EC, Commission Directive 2005/28/EC, the 12th Amendment to the German Medicines Act (AMG), and the GCP Regulation. All laws and guidelines serve especially to protect the study participants.
Before the substances may be used, an application for approval of the clinical trial must be submitted in accordance with § 40 - 42 AMG and § 7 of the GCP regulation. A manufacturing authorization from the pharmaceutical company in accordance with § 13 AMG must also be available and the investigational product must be labeled in accordance with § 5 of the GCP regulation. According to GCP § 4, the sponsor must ensure that the manufacture and testing of the preparation to be tested is carried out in accordance with the specifications of the submittedInvestigator Medicinal Product Dossier ( IMPD). The manufacture of investigational medicinal products must be carried out in accordance with "Good Manufacturing Practice". The manufacturing sites and testing laboratories must be suitable for testing and comply with the required standards. In addition to manufacturing regulations, there are also numerous provisions on shipping and quality requirements for substances to be tested in studies.
Investigational medicinal products must be labelled externally and contain the following information:
- Contact details of the sponsor - the main responsible person must be identifiable
- Protocol number and EudraCTnumber
- name of the investigational medicinal product with batch number and encryption, if applicable
- Shelf life and storage instructions (e.g. refrigerator)
- Quantity and details of the application (e.g. i.v.- or peranal)
- Dosage details
- Assignment code to the study participant
- Precautions (e.g. advice that the product should be stored out of the reach of children)