PharmacoVigilance (PV)/ Drug Safety

Friday, 17 April 2020

Can Companies or Authorities differ with ICH guidelines during their routine Pharmacovigilance activities?

ICH Guideline Implementation status by Industries and Authorities 


A report was published to know the status of implementation of ICH guidelines by Industries or Authorities in the year 2019.

It seems to be interesting as there are several companies have differ in opinion of implementing published ICH guidelines. However, they have implemented these ICH guidelines with modifications and justifying with a rationale. Majority of Authorities have implemented these ICH guidelines with adequate compliance.

The result of this survey showed the final status by both Industries and Authorities as follows:

Refer 2019 Project report: MONITORING THE ADEQUACY OF IMPLEMENTATION AND ADHERENCE TO INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH) GUIDELINES


To summarise, I feel primarily we shall implement any kind of guidelines including ICH guidelines as it is if it is more appropriate; The same guidelines can be implemented with modifications with sufficient rationale in case of any subjective changes are necessary.

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