News about GMP/cGMP


EMA: Overview on comments on drug device guidance

EMA: Overview on comments on drug device guidance

On 6 December 2021, the EMA published all stakeholder comments received on the Guideline on quality documentation for medicinal products when used with a medical device (we reported). It will enter into force on 1 January 2022. Comments were received from 36 different stakeholders from all over Europe, including e.g., MedTech Europe, Medicines for Europe or the Parenteral Drug Association, PDA.

The comprehensive overview with all comments was published six months after the publication of the final Guideline.  Also in retrospect, it is well worth looking at the document: In tabular format, it provides a very good overview of the comments which are directly linked to the EMA's action and thus indicate the resulting changes.


EMA: Overview of comments