International Conference On Harmonisation of Technical Requirements For Registration of Pharmaceutic - Process - Step 3: Regulatory Consultation and Discussion

Step 3: Regulatory Consultation and Discussion

The draft becomes subject of consultation in the three regions. It is published in the European Union (as draft CHMP or CVMP guideline), Japan (after translation by MHLW), and the USA (as draft guideline in the Federal Register) and everybody within these regions can comment on it. There is also an opportunity for companies, associations and authorities in non-ICH regions to comment on the draft, which is distributed by IFPMA and WHO. After obtaining all consultation results, the EWG will be resumed. A new rapporteur will be appointed from the regulatory party, preferably from the same region as the previous rapporteur. The same procedure described in Step 1 is used to address the consultation results into the Step 2 Final Document. The draft document to be generated as a result of the Step 3 phase is called Step 4 Experts Document.

If industry and regulatory EWG members agree on the alterations as a result of the consultation, the Step 4 Experts Document is signed by the EWG regulatory experts only (Step 4 Experts Signoff) and submitted to the SC to request adoption as Step 4 of the ICH process..

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