Draft Guideline on clinical investigation of medicinal products for the treatment of acute heart failure (CHMP/EWP/2986/03 Rev 1)

Draft Guideline on Clinical Investigation of Medicial Products in the Treatment of Diabetes Mellitus

Discussion in the Efficacy Working Party June 2000 – May 2001 Transmission to CPMP July 2001 Release for consultation July 2001 Deadline for comments January 2002 Discussion in the Efficacy Working Party April 2002 Transmission to CPMP May 2002 Adoption by CPMP May 2002 Date for coming into operation November 2002 Draft Rev. 1 agreed by Efficacy Working Party January 2010 Adoption by CHMP for r...

Guideline on clinical investigation of medicinal products in the treatment of lipid disorders

This guideline replaces the ‘Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders (CPMP/EWP/3020/03)’. Rev. 1 and Rev. 2 were combined: Rev. 1 was regarding imaging surrogate endpoints Rev. 2 was regarding the need for outcome studies based on safety data at the time of Marketing Authorisation Application.

Guideline on the investigation of drug interactions

Discussion in the Efficacy Working Party (EWP) June/October 1996 February 1997 Transmission to the CPMP March 1997 Transmission to interested parties March 1997 Deadline for comments September 1997 Re-submission to the EWP December 1997 Approval by the CPMP December 1997 Date for coming into operation June 1998 Draft Rev. 1 Agreed by the EWP April 2010 Adoption Rev. 1 by CHMP for release for co...

Guideline on clinical investigation of medicinal products in the treatment of depression rev 2

Discussion in the Efficacy Working Party July 1997 Transmission to CPMP March 2001 Release For Consultation March 2001 Deadline for comments September 2001 Discussion in the Efficacy Working Party November 2001 Transmission to CPMP April 2002 Rev 1. Adopted by CPMP April 2002 Rev 1. Coming into operation October 2002 Draft Agreed by CNSWP/BSWP/PDCO May 2011 End of consultation (deadline for com...

Committee for Medicinal Products for Human Use (chmp) Draft Guideline on Clinical Investigation of Medicinal Products for the Treatment of Juvenile Idiopathic Arthritis