Adoption of the ICH Q12 guideline: New Horizons for Efficient Product Supply Chain Management for a Key Global Market

On August 25, China National Medical Products Administration (NMPA) officially announced implementation of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q12 guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.  There will be a 24 month transition period as of August 25 2023. This is in the context of a total of 60 of 63 ICH guidelines in safety (S), efficacy (E), quality (Q), and multidiscipline (M) being formally adopted since June 2017, which is when China officially joined the ICH. 

The goal of the ICH Q12 guideline is the global harmonization of lifecycle management for pharmaceuticals. In China, supplemental applications are mandatory for major post-approval changes. Further, major CMC variation normally require sample testing by the National Institutes for Food and Drug Control (NIFDC). But when the sample testing is initiated, the review timeline for major post-approval changes is extended from 60 to 200 working days; this creates significant regulatory complexity and challenges to products with the global supply chain. 

Now Q12 is adopted, the Post Approval Life Cycle Management Plans (PLCM) & Post-Approval Change Management plans (PACMP) will be powerful tools to manage major CMC variations in China. Especially when the CMC variation report category can be downgraded from “pre-approval” (Major) to “file for record” (Medium), significant regulatory relief can be expected for CMC variation management, i.e. shorten the variation approval timeline in China and thereby avoiding drug product stock being held more than 1 years waiting for approval.  

However, to take advantage of this new opportunity, quality advice from experienced consultants is key.  Parexel‘s experienced team can help BLA, ANDA or NDA sponsors best present “prior knowledge” or QbD experience on pharmaceutical development to take advantage of the ICH Q12 implementation. For example, Parexel CMC expert Potla, Ramesh gave the following tips regarding ICH Q12 implementation at the recent DIA China 2023 Annual conference [June 16, Suzhou, ICH Q12&13 section]. 

1. “Regulatory Agility” is key for success in the global regulatory market, including China. Agility is critical to realize and reap the full benefits of the new ICH Q12 post-approval CMC change management paradigm.
2. Due to the supply chain constraints of certain raw materials experienced during the COVID-19 pandemic and beyond, several biopharma companies have experienced a significant lag in their production schedules.  This has posed a high-risk for potential stockout of important medicines in some global markets.  ICH Q12 is poised to help alleviate these stockout issues.
3. In the event that a vendor can’t supply a specific raw material for any number of reasons, the ability of biopharma industry to switch to alternate vendor depends on how quickly they can update their regulatory files.   The speed to compliance with local market regulations in a specific market jurisdiction (US, EU, China etc.) is critical.

In summary, Dr. Potla concluded his presentation by stressing that maximizing “Regulatory Agility” with regards to raw materials depends upon a combination of 

(a) reducing excess and unnecessary details for materials in regulatory submissions/dossiers；

(b) QbD approaches for qualification and implementation of raw materials for intended use.

Parexel has a deep bench of Subject Matter Experts (SME) ready to support clients with CMC variation management globally. Our strong scientific and local expertise across the world can help clients reach their goals with speed, agility and precision. 
 

Return to Insights Center