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As ICH Q14 is progressively implemented, exports of biological active pharmaceutical ingredients are now subject to new quality requirements.

2026-10-19

Pharmaceutical regulatory authorities worldwide are actively promoting the implementation of the ICH Q14 guideline on analytical methods, introducing stricter standards for analytical methods and material traceability of biological active pharmaceutical ingredients (APIs). Companies producing urinary-derived APIs therefore need to further refine their source material control systems.

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new center

As ICH Q14 is progressively implemented, exports of biological active pharmaceutical ingredients are now subject to new quality requirements.

Breakthrough through scientific research to extract difficult problemsMassive production and partners to expand the vast world together

new
center

Breakthrough through scientific research to extract difficult problems
Massive production and partners to expand the vast world together