Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - 1.5 Regulatory requirements

Document information
Reference	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
Validity area	WHO
Scope(s)	HM
Document name	WHO - Guidelines for GCP for trials on pharmaceutical products*
Version / Revision	1995
Status	Current
Document type	International guideline
Language(s)	EN
Description	World Health Organization WHO Technical Report Series, No. 850, 1995, Annex 3 Guidelines for good clinical practice (GCP) for trials on pharmaceutical products*
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Scope	HM
Document part	Glossary - 1.5 Regulatory requirements
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Regulatory requirements for clinical trials: national obligations

Content

1.5 Regulatory requirements Countries in which clinical trials are performed should have regulations governing the way in which these studies can be conducted. The pre-trial agreement between the sponsor and investigator(s) should designate the parties responsible for meeting each applicable regulatory requirement (e.g. application to or notification of the trial to the relevant authority, amendments to the trial protocol, reporting of all adverse events, and notifications to ethics committee). All parties involved in a clinical trial should comply fully with the existing national regulations or requirements. In countries where regulations do not exist or require supplementation, relevant government officials may designate, in part or in whole, these Guidelines as the basis on which clinical trials will be conducted. The use of these Guidelines should not prevent their eventual adaptation into national regulations or laws. Neither should they be used to supersede an existing national requirement in countries where the national requirement is more rigorous.