Bioequivalence and Bioavailability Forum

Hi Debbie,

As per the Turkey MOH Good Clinical Practices section 6.1.50 - The sponsor should maintain sufficient quantities of the investigational products used in the trials to reconfirm specifications, should this become necessary, and maintain records of batch sample analyses and characteristics. Pursuant to the applicable regulation requirements, the responsibility rests with the manufacturing company for maintaining sufficient quantities of the investigational products (including drugs of comparative arm) marketed or available in the market in our country for serial sample analysis, the sponsor conducting the clinical trial may not be held responsible.

Link for reference: http://www.iegm.gov.tr/Default.aspx?sayfa=regulations&lang=en&thelawtype=12&thelawId=399


Thanks

Kiran Kumar