Why China’s Evolving Approach to Combination Products Matters Globally

Why China’s Evolving Approach to Combination Products Matters Globally

Recent developments suggest that combination products are no longer a niche or emerging topic in China. They are entering a more structured stage of regulatory discussion, industry collaboration, and capability building.

Discussions across industry, including most recently at CPHI China, reflect this shift, with increasing attention being given to regulatory pathways, practical implementation, and the role of Human Factors Engineering in product development.

For international pharmaceutical companies developing or bringing injectable combination products to China, this shift is worth watching closely.

A More Structured Approach to Combination Products

One of the most notable developments is the increasing attention being given to the differences between China, the US and the EU in terms of regulatory pathways, review expectations and practical implementation.

In previous discussions with global clients, we often described China’s combination product framework as an area that may gradually move closer to international regulatory thinking, but still needed time to evolve.

Today, that evolution feels more tangible.

One indication of this progress is the completion of a research project, led by Southeast University, examining China’s review and approval mechanism for drug-device combination products.
The work has received positive recognition from the National Medical Products Administration (NMPA), with further technical exchange and training expected around the findings.

A further indication is the forthcoming Blue Book on injectable drug-device combination products. This collaborative industry and regulatory science report brings together expertise from across the pharmaceutical, device and regulatory communities, with PDD contributing the chapter on Human Factors Engineering.

The report aims to provide an objective overview of the current status of injectable combination products in China, clarify future development directions, and support continued progress in regulatory understanding, industry practice, and product quality.

Taken together, these developments suggest that combination products in China are moving beyond a relatively specialised regulatory topic towards a more systematic and professionalised stage of development.

Human Factors as a Development Mindset

One of the clearest themes emerging from recent discussions was the increasing prominence of Human Factors Engineering. This may suggest that, while awareness is growing, there remains considerable scope to further integrate Human Factors into the development and regulation of drug-device combination products in China. Doing so would bring it more closely into line with established international practice.