Three years after the publication of a concept paper Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”, the ICH has now published the Step 2 draft document including an Annex with illustrative examples. The document was endorsed on 16 November 2017.

The intention behind ICH Q12 is to provide guidance on a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the lifecycle of a product. The guidance addresses the commercial phase and should be seen as the logical continuation of the ICH Q8 – Q11 Guidelines.

As the ICH points out “In certain ICH regions, the current ICH Q12 guideline is not fully compatible with the established legal framework with regard to the use of explicit Established Conditions ('EC') referred to in Chapter 3 and with the Product Lifecycle Management ('PLCM') referred to in Chapter 5 as outlined in this guideline. These concepts will, however, be considered when the legal frameworks will be reviewed and, in the interim, to the extent possible under the existing regulate on in these ICH regions.

The guideline applies to

  • Pharmaceutical drug substances (i.e. APIs)
  • Pharmaceutical drug products (incl. marketed chemical, and biotechnological/biological products)
  • Drug-device combination products that meet the definition of a pharmaceutical or biotechnological/biological product.

According to the Q12 EWG Work Plan, the 31-pages draft guideline is planned to being finalised in the second quarter of 2018.

Source:

ICH Q12 Draft

ICH Q12 Annex