Short Guidance

 

This guidelines aim to provide members with some practical advices in order to organise their application file for endorsement of documents related to Infection.

For any further information please find the EBJIS Guidelines to Apply for Endorsement of Documents

 

Fracture-related Infection Consensus Meeting 2018 

Please click here for further information. 

First short guide: EBJIS FRI Guidelines 2018

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The European Medicines Agency has released for public consultation a draft concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections.

This concept paper proposes the development of a single guideline on the clinical evaluation of medicinal products indicated for treatment of bacterial infections. The development of this single guideline is intended to merge, revise and add to the guidance that is currently included in two separate documents as follows: guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev. 2), adopted in 2011 and in force since 2012 and the addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (EMA/CHMP/351889/2013), adopted in 2013 and in force since 2014.

The concept paper is available by clicking here.

Comments should be provided using this template and sent to This email address is being protected from spambots. You need JavaScript enabled to view it. by 13/09/2018.

Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.

For more information on the European regulatory system for medicines, please click here (brochure available in all languages).

EBJIS Statutes. Read the full text here.