• 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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