News about GMP/cGMP

08.11.2019

ICH: What about the implementation of the ICH guidelines worldwide?

On 4 November 2019, the ICH has published the survey results on the level of implementation and adherence to ICH Guidelines within its Regulatory Member and Observer countries. The results have been compiled in a 26 page report. Especially interesting is the resulting tabular overview of the data including a search function:

The review of progress in international harmonisation and the coordination of all measures is an important focus of the ICH. With this tool, an overview of the implementation status of ICH Guidelines under Step 5 of the ICH process is easily at hand:
A specific guideline or topic and/or an ICH member country can be selected in order to determine the implementation status, the date of implementation and the corresponding reference number of a Member State.

At “Step 5” level, the ICH Guidelines are implemented by the respective ICH Regulatory Members and Regulatory Observers in their countries. For ICH Regulatory Observers, the implementation of (certain) ICH guidelines is a prerequisite for becoming an ICH Regulatory Member.


Source:

ICH Guideline to Implementation

ICH 2019 Project Report



Comments

Good initiative to common guideline across the globe for better understanding the human requirements for GMP in pharmaceutical industry. Being and common requirement of human for healthy world irrespective of demographically distinguish.
BIPIN CHANDRA THAPLIYAL BIPIN 13.11.2019

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