GCP regulation
| Basic data | |
|---|---|
| Title: | Ordinance on the Application of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use |
| Short title: | GCP regulation |
| Abbreviation: | GCP-V |
| Type: | Federal Ordinance |
| Scope: | Federal Republic of Germany |
| Issued on the basis of: | Section 12 Paragraph 1b No. 2 AMG , Section 42 Paragraph 3 AMG |
| Legal matter: | Special administrative law , pharmaceutical law |
| References : | 2121-51-41 |
| Issued on: | August 9, 2004 ( BGBl. I p. 2081 ) |
| Entry into force on: | August 14, 2004 |
| Last change by: |
Art. 8 G of October 19, 2012 ( Federal Law Gazette I p. 2192, 2220 ) |
| Effective date of the last change: |
October 26, 2012 (Art. 15 para. 1 G of October 19, 2012) |
| Expiry: | Announcement follows (Art. 13 G of December 20, 2016, Federal Law Gazette I pp. 3048, 3065 ) |
| GESTA : | M021 |
| Please note the note on the applicable legal version. | |
In Germany, the GCP regulation regulates in detail the approval and implementation of clinical studies with medicinal products on humans. It prescribes Good Clinical Practice (GCP) for all such clinical studies. The aim of the regulation is to protect the safety of the patients and test subjects participating in the studies and to ensure the integrity of the study results.
The ordinance is derived from the authorization to issue ordinances in Section 12 (1b) No. 2 and Section 42 (3) of the Medicines Act . It also serves to transpose Directive 2001/20 / EC on the application of good clinical practice and other European directives into national law.
The GCP regulation is divided into five sections. Section 1 contains general provisions, Section 2 regulates in detail the requirements for test drugs , in particular their labeling. Section 3 contains the regulations for the approval of a clinical study by the competent higher federal authority; depending on the drug, this is either the Federal Institute for Drugs and Medical Devices or the Paul Ehrlich Institute . The evaluation by the ethics committee is also dealt with in section 3. Section 4 contains provisions on the documentation and notification obligations of the examiners and sponsors as well as the notification obligations of the higher federal authorities. The GCP inspections of the authorities, who are allowed to inspect the test center, the facilities of the sponsor of the study and the facilities of the manufacturer of the test drug, are also regulated in this section. Section 5 contains transitional and final provisions.
