ATMP Response to ATMP

If you like to know what others think about the ATMP GMP guideline proposed by the European Commission (EC) and the European Medicines Agency (EMA), please read the summary of the EC:

“SUMMARY OF THE REPSONSES TO THE TARGETED STAKEHOLDER CONSULTATION ON THE DEVELOPMENT OF GOOD MANUFACTURING PRACTICE FOR ADVANCED THERAPY MEDICINAL PRODUCTS PURSUANT TO ARTICLE 5 OF REGULATION 1394/2007“.

All 53 comments received during the stakeholder consultation process from june to september 2016 were recorded, analyzed and summarized.

Most of the commentators welcomed the guideline. Requests remained on the relation between the actual draft guidelines on GMP specific to advanced therapy medicinal products to the GMP guidelines. They have to be clarified due to the specific characteristics of ATMPs. Therefore, some additional adaptations are required in terms of manufacturing conditions, validation of the aseptic manufacturing process, and ongoing stability testing. Just as important is a greater flexibility regarding the tasks of the qualified person.

Read the summary of the EC or have a look at the list of all comments submitted to the EC in detail.

EC summary of the responses to the draft of ATMP GMP guide

Detailed responses to the draft of the ATMP for GMP guide

Draft guideline GMP for ATMPs

Find out also about our services on the subject of GMP for ATMPs