Post-Approval Change Management - Does ICH Q12 offer a solution?

The ICH Q8-Q11 guidelines, which have been published between 2005 and 2011, introduce Quality by Design (QbD) concepts to product development and manufacturing. However, the regulatory flexibility expected from the mentioned ICH guidelines still is not achieved. Most of the regulatory filings contain more information and raise more questions than ever before. Globally applicable changes are a logistical challenge due to different timelines and submission requirements for post-approval changes. Hence, the risk of shortages, supply deviations and noncompliance situations is increased.

In December 2017 the draft guidance ICH Q12 entitled "Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management" has been published for comment. It applies for products, including biologics, APIs (active pharmaceutical ingredients) and drug -device combinations. ICH Q12 explicitly addresses post-approval changes for products already on the market. Following ICH Q12 most manufacturing and analytical changes can be managed efficiently under the pharmaceutical quality system (PQS) of a company without regulatory approval prior to implementation. Therefore cooperation of regulators (assessors and inspectors) is required by ICH Q12. Other Key aspects of Q12 are:

  • Established Conditions (ECs).
  • Post-Approval Change Management Protocols (PACMPs) for planned changes. The PACMP is a tool that provides predictability regarding the information to support a CMC change and the type (category, which is usually one step lower than without PACMP) of regulatory submission based on prior agreement between the MAH (marketing authorization holder) and the responsible competent authority.
  • Product Life Cycle Management (PLCM) document for proactive management of the product lifecycle.

The Annexes of ICH Q12 contain illustrative examples on ECs, PACMPs and PLCM documents for chemicals and biologics.

ICH Q12 has the potential to reduce costs and time burdens for regulators and the industry. One of the real benefits could be the potential regulatory commitment among ICH regions related to what is "supportive information" within regulatory submissions. This should also lead to greater application of innovative technologies in manufacturing and control (i.e. analytical methods) in a timely manner.

In Europe, the draft of ICH Q12 can be commented until 18 December 2018.

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