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April 2020 CDH/084/2008/Rev.7CMDh Best Practice Guide on the use of the electronic Common Technical Document (ECTD) in the Mutual Recognition and Decentralized Procedures Table of contents 1. Introduction
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Refer to the CMDh Best Practice Guide template to understand the specific requirements and sections
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Who needs cmdh best practice guide?
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Pharmaceutical companies seeking marketing authorization for their products in the EU
02
Regulatory authorities and agencies responsible for reviewing drug applications and ensuring compliance with safety and efficacy standards
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What is cmdh best practice guide?
The CMDh Best Practice Guide provides guidance and recommendations on the procedures and processes for the coordination of the marketing authorization of human and veterinary medicines.
Who is required to file cmdh best practice guide?
Marketing authorization holders (MAHs) are required to file the CMDh Best Practice Guide.
How to fill out cmdh best practice guide?
The CMDh Best Practice Guide can be filled out online through the specified regulatory platform and must include all relevant information required by the guideline.
What is the purpose of cmdh best practice guide?
The purpose of the CMDh Best Practice Guide is to ensure the harmonized and efficient coordination of the marketing authorization procedures for medicines across the EU.
What information must be reported on cmdh best practice guide?
The CMDh Best Practice Guide requires information on the medicinal product, the marketing authorization holder, the national authority involved, and the progress of the approval process.
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