Clinical evaluation of medicinal products intended for treatment of hepatitis B - Scientific guideline

The proposed guideline will replace guideline on the clinical evaluation of medicinal products intended for the treatment of Hepatitis B.

In recent years there have been several applications for scientific advice on new products and treatment strategies aimed at achieving functional cure, including finite and combination treatment regimens. Furthermore, there has been development of new antiviral and immunomodulatory treatment options with mechanisms of action different to those of nucleos(t)ide analogues (NUCs) or peg-interferon alfa-2a (PEG-IFN). Therefore, a revision of the guideline is proposed to reflect these new developments and the implications for clinical development programmes.

Keywords: Chronic hepatitis B (CHB), hepatitis B virus (HBV), functional cure.

Current version - under revision

Concept paper on the revision of the guideline on the clinical evaluation of medicinal products intended for the treatment of Hepatitis B - Revision 1

Draft: consultation closedConsultation dates: 26/01/2024 to 30/04/2024Reference Number: EMA/CHMP/28391/2024Summary:

The proposed guideline will replace guideline on the clinical evaluation of medicinal products intended for the treatment of Hepatitis B.

In recent years there have been several applications for scientific advice on new products and treatment strategies aimed at achieving functional cure, including finite and combination treatment regimens. Furthermore, there has been development of new antiviral and immunomodulatory treatment options with mechanisms of action different to those of nucleos(t)ide analogues (NUCs) or peg-interferon alfa-2a (PEG-IFN). Therefore, a revision of the guideline is proposed to reflect these new developments and the implications for clinical development programmes.

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Revision 1

Concept paper on the revision of the guideline on the clinical evaluation of medicinal products intended for the treatment of Hepatitis B - Revision 1

Draft: consultation closedConsultation dates: 26/01/2024 to 30/04/2024Reference Number: EMA/CHMP/28391/2024Summary:

The proposed guideline will replace guideline on the clinical evaluation of medicinal products intended for the treatment of Hepatitis B.

In recent years there have been several applications for scientific advice on new products and treatment strategies aimed at achieving functional cure, including finite and combination treatment regimens. Furthermore, there has been development of new antiviral and immunomodulatory treatment options with mechanisms of action different to those of nucleos(t)ide analogues (NUCs) or peg-interferon alfa-2a (PEG-IFN). Therefore, a revision of the guideline is proposed to reflect these new developments and the implications for clinical development programmes.

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

First version

Guideline on the clinical evaluation of medicinal products intended for treatment of Hepatitis B - First version

AdoptedReference Number: CHMP/EWP/6172/03Legal effective date: 01/09/2006