Clinical Trial & Global Clinical Trial

• ^{Monitoring of Clinical Trials - regardingNEW!}

• Details of Global Clinical trial approved in 2012^NEW!

• Advisory notice on clinical trial  

• Notice: Expansion of panel of experts for evaluation of applications of New Drugs, Clinical Trials and Medical Devices 

• Office Order: Submission of Periodic Safety Update Reports (PSURs) 

• New Drugs Recommended by NDAC for marketing authorization in India without Local Clinical Trial (Till August 2012)

• ^{Registration of Clinical Trials}

• Guidance on Clinical Trial Inspection

• Good Clinical Practice

• Draft Guidance For Industry On Requirement Of Chemical & Pharmaceutical Information Including Stability Study Data Before Approval Of Clinical Trials / BE  Studies

• DCG(I) approved Clinical Trial registered in Clinical Trial Jan 2013^NEW!

• System of Pre-screening for submission of reports of SAEs to CDSCO^NEW!

• System for the Pre - Screening of the applications for registration of Ethics Committee^NEW!

• Panel of Experts for examination of reports of Serious Adverse Events (SAEs) of Deaths^NEW!