Full Paper Here.

Both guidelines on the core SmPC for human plasma-derived hepatitis B immunoglobulin, i.e. for intramuscular use (CPMP/BPWG/4222/02) and for intravenous use (CPMP/BPWG/4027/02), have been in operation since November 2006. Other specific guidelines on core SmPC, i.e. Core SmPC for human rabies immunoglobulin for intramuscular use (CPMP/BPWG/3728/02), Core SmPC for human tetanus immunoglobulin for intramuscular use (CPMP/BPWG/3730/02) and Core SPC for human varicella immunoglobulin for intramuscular use (CPMP/BPWG/3726/02) have been in operation since February 2006. Nevertheless, no guideline on the clinical investigation of these human specific immunoglobulins is currently available. As the regulatory experience from the marketing authorisation applications, especially for human plasma-derived hepatitis B immunoglobulin has been developing during the past decades, the development of a guideline appears appropriate.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Turn your Business Into an Investor Magnet

How to Write a Business Plan – Free E-Course

Get the secrets that turns your project into an investment magnet, 100% of our clients raise the finance they need to take their projects to the next stage, we will share these secrets with you. – Sign up for Free

Grow your Expertise for Free

As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

A full copy is available here.

Introduction

Both guidelines on the core SmPC for human plasma-derived hepatitis B immunoglobulin, i.e. for intramuscular use (CPMP/BPWG/4222/02) and for intravenous use (CPMP/BPWG/4027/02), have been in operation since November 2006. Other specific guidelines on core SmPC, i.e. Core SmPC for human rabies immunoglobulin for intramuscular use (CPMP/BPWG/3728/02), Core SmPC for human tetanus immunoglobulin for intramuscular use (CPMP/BPWG/3730/02) and Core SPC for human varicella immunoglobulin for intramuscular use (CPMP/BPWG/3726/02) have been in operation since February 2006.

Nevertheless, no guideline on the clinical investigation of these human specific immunoglobulins is currently available.

Problem Statement

Due to the recent increase of submission of marketing authorisation applications for human plasma-derived hepatitis B immunoglobulin (HBIG), several questions regarding the required clinical data arise. Furthermore, compliance to the current available Core SmPC being recommended, a specific guidance relating to the clinical investigation of HBIG products appears appropriate. The expansion of this NfG to all specific immunoglobulins needs to be considered.

Discussion

Considering the similar content of the Core SmPC for human plasma-derived hepatitis B, human rabies, human tetanus and human varicella immunoglobulin, elaborated during a single wave, and the similar pharmacological properties, a single approach can be followed to elaborate the NfG relating to the clinical investigation of specific immunoglobulins. This guideline can address the differences in the clinical requirements of these immunoglobulins and the aspects that could be common for all of them.

Recommendation

Indeed, the clinical approach can be based on three pillars:

• Product compliance with relevant Ph.Eur monographs
• PK data should show expected characteristics of an immunoglobulin,
• Confirmatory data (for example for HBIG: anti-HBs levels >100IU/l, recurrence rates).

Then, some points pertaining to the specific management of the pathology should be addressed. Notably, the following aspects should be studied and taken into account:

• The therapeutic indications (kind of prophylaxis, combination with the vaccine),
• The posology and the method of administration

The EMEA is looking for industry input into the process of drafting these guidlines and Interested parties with specific interest in this topic will be consulted during the preparation of this guideline including IPFA, PPTA and WHO. Other EMEA Working Parties including Efficacy Working Party and Vaccine Working Party will be involved during the preparation.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Turn your Business Into an Investor Magnet

How to Write a Business Plan – Free E-Course

Get the secrets that turns your project into an investment magnet, 100% of our clients raise the finance they need to take their projects to the next stage, we will share these secrets with you. – Sign up for Free

Grow your Expertise for Free

As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.