Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Close this folderProtection of trial subjects in clinical trials
View the documentCross-border movement of clinical trial subjects
View the documentCross-border movement of clinical trial subjects and regulatory communication
View the documentEthical principles and protection of trial subjects in China
View the documentRecommendations
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Cross-border movement of clinical trial subjects and regulatory communication

Dr Rolf Spang, Switzerland

Switzerland is located in the heart of Europe and is divided into 26 cantons which each license physicians and establish ethical committees. Before the recent establishment of a federal authority it was the responsibility of the InterCantonal Office for the Control of Medicines to oversee clinical trials and good clinical practices (GCP).

Switzerland keeps a register of all clinical trials and it is the responsibility of the Swiss Agency for Therapeutic Products to consider applications. Sponsors have to submit documents, such as approval by the ethics committee, the study protocol, the investigators’ brochure and the contract between the sponsors and the contract institute.

Since Switzerland has common borders with several EU countries, there are frequent cross-border movements linked to recruitment of subjects for clinical trials. However GCP regulations have not been developed with this particular situation in mind. When the Swiss authority learned of the clinical trial described, certain issues were identified:

• Direct communication and exchange of information between regulatory authorities is needed when overseas recruitment is discovered.

• Consent documents should be written in the local language understandable to the individual subject.

• The trial subjects should be followed up once the trial is finished, in order to safeguard their health.

 

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