• March 2020

On 4th March 2020, EMA published adoption of ICH Q12 guideline along with an implementation note which clearly states that the tools and concepts in the ICH Q12 guideline that are not foreseen in the EU legal framework will be considered when this framework will be reviewed. In the meantime, the European Commission, together with the EMA and the National Competent Authorities, will continue to work on the implementation of the ICH Q12 guideline within the existing EU legal framework.

Established Conditions and Product Lifecycle Management (PLCM) Document are not considered compatible with the existing EU legal framework on variations. EMA recommends that the legal framework always takes precedence over technical and scientific guidelines. Thus, definition of Established Conditions and their reporting categories must follow the requirements laid down in the current EU Variations Regulation and associated EU Variations Guidelines. With respect to the Product Lifecycle Management (PLCM) document, in case such a document is submitted, it cannot be currently recognized in the EU, due to the fact that it is not referred to in the EU legal framework.

  • Kinapse considers this decision from the EMA potentially limits the overall anticipated benefits of ICH Q12 until the EU legal framework is updated.
  • March 2020

After the adoption of ICH Q12 Guideline in November 2019, a Step 4 Introductory Training Presentation has been published on ICH website on 19th February. Expert Working Group recommends MAHs who wish to use tools described in ICH Q12 should consult regulatory authorities’ websites about the implementation of ICH Q12 in their region. Read more about this here.

It’s worth noting that USFDA and PMDA Japan are in process of implementing this guideline and have already started pilot programs for Established Conditions and PACMP, respectively.

Health Canada are not in a position to implement the tools at present and are considering a pilot program similar to that of the PMDA.

EMA published “Overview of comments received on draft guideline” in January last year and no further update has been announced since. Kinapse anticipates revision of EU Variations Regulation to fully implement the concepts of Q12 guideline.

The implementation of this transformational guideline for management of post approval changes in different regions will be an interesting journey.

Kinapse is keeping a close watch on this important topic. If you want to learn more and need help in understanding and acting on the guidance, please contact us.

  • December 2019

Kinapse welcomes you to ICH Q12

The key milestone is reached with adoption (Step 4 of ICH process) of ICH Q12 Guideline on the Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. On 4th December, ICH published final Q12 guideline and its Annex documents on the website, the next stage will be the implementation of ICH Q12 across the ICH regions.

Effective implementation of tools as outlined in the finalized guideline should enhance product knowledge and Industry’s ability to manage many CMC changes effectively under the company’s Pharmaceutical Quality System (PQS) without the requirement for extensive regulatory assessment prior to implementation.

Use the button below to download the PDFs and watch this space for support and guidance from the Kinapse team in 2020.

ICH Q12 Guidelines
ICH Q12 Annexes
  • February 2019

Kinapse Contributes Comments to ICH Guideline Q12 :

An overview of comments received on guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Kinapse, a Syneos Health Company recognises guideline ICH Q12 as having the potential to completely change the regulatory post-approval landscape of the Pharma industry. Designed to complement existing Q8-Q11 guidelines to enable a full realization of more flexible regulatory approaches, the Q12 guideline relates to technical and regulatory considerations for pharmaceutical product lifecycle management.

On the 18th of January 2019, the European Medicines Agency published comments received during a public consultation of this draft guideline. Kinapse are proud to demonstrate our continued commitment to regulatory harmonization by having our comments included.

Follow the link below for more regarding guideline ICH Q12 and see below for Kinapse’ comment:


Kinapse’s General Comment:

“This is a good initiative; defining established conditions (ECs) for a drug product should minimize number of variations based on critical risk assessment and scientific approach.

The proposal (if adopted by a company) can pose a challenge for legacy products than newer products in terms of generating supplementary developmental studies for proposing ECs.

Both the Established conditions (ECs) and Product Lifecycle Management (PLCM) are the core of the Q12 guideline. Incompatibility of these concepts with the established legal framework is a matter of concern at the moment.”

To read more comments by Kinapse and other organisations:

Click here to download the overview of comments received on ICH guideline Q12.

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