Overview



National Health Regulatory Authority (NHRA) is mandated by law to regulate, authorize and oversee the conduct of clinical researches and trials in the Kingdom of Bahrain.


The main objective from that is to ensure that the conducted clinical/trials research is supported by adequate ethical, scientific, regulatory and legal frameworks, that protect human subject within the clinical trials in any health facility.

NHRA-Clinical Trial Committee has issued the regulations to control the planning, implementation and reporting on trials and clinical research, implement strategies and to confirm that NHRA has to regulate such research:

1-Clinical Trials Regulations Document in the Kingdom of Bahrain

2-Requirements for Independent Research Ethics Committees participate in the grant approval clinical trials in the Kingdom of Bahrain.

All current rules and regulations based on international laws and standards for good clinical practice, presented by leading regulatory bodies such as the World Health Organization and the U.S. Food and Drug Administration (FDA) and Emma (European Medicines Agency) and the International Conference on technical requirements for registration of pharmaceuticals for human use (ICH).


Clinical Trials Committee in NHRA formulated by decree No (52)/2015 has been issued from SCH.

 

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