EMA Publishes Comments Received on ICH Q2(R2) and Q14

Recommendation

24/25 April 2024

QC Compliance Manager - Live Online Training

In March 2022 the European Medicines Agency (EMA) published the ICH guidelines Q2(R2) on validation of analytical procedures and the ICH Q14 on analytical procedure development for public consultation (Step 2b). The deadline for submitting comments to the draft versions was 31 July 2022. For further information, please see ICH Guidance Q14 / Q2(R2) - Analytical Method Development/Method Validation Published for Consultation.

On 24 August 2022, an overview of the comments received was provided. The comments will be sent to the ICH Q2(R2) / ICH Q14 Expert Working Group (EWG) for consideration in the context of Step 3 of the ICH process.

Comments received on ICH Q2(R2) and ICH Q14

A large number of comments were received on both drafts, which are compiled in a 72-page PDF document (ICH Q2(R2)) and a 54-page PDF document (ICH Q14). Both documents are divided into general comments and specific comments on the text.

Among the organisations that submitted comments are APIC, EFPIA, European Association of Nuclear Medicine, ISPE, Medicines for Europe, and PPTA.

Feedback from ECA's Analytical Quality Control Group

The ECA Foundation together with its European QP Association also provided feedback to the EMA's public consultation on the ICH Q2(R2) and Q14 guidelines. The feedback was prepared by the Foundation's Analytical Quality Control Group on their behalf.

According to the ECA Foundation / European QP Association, ICH Q2 does not integrate with Q14. "ICH have failed to write a single integrated document to provide an encompassing approach to procedure development, validation and operational use." Attention is also drawn to the following: "There is no complete analytical procedure life cycle described in either Q2 or Q14" and "the operational phase of the life cycle is omitted entirely from both documents. There is zero mention of the most important and longest phase of the life cycle."

FDA starts Consultation

In the meantime, on 26 August 2022, the U.S. Food and Drug Administration (FDA) has also published the two drafts ICH Q2(R2) and ICH Q14 for comments. The FDA asks to "submit either electronic or written comments on the draft guidance by September 28, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance."

Please see the Notice in the Federal Register for more information.