The production and manufacturing of Chinese herbal medicine for use in clinical trials by Chinese herbal medicine factories shall, unless otherwise regulated by regulations of this Chapter, be governed by other relevant regulations prescribed in this Part.

Where Chinese herbal medicine factories have not yet established validated manufacturing processes for Chinese herbal medicine for use in clinical trials, or have not yet established comprehensive manufacturing control standards, aforesaid factories shall establish in writing operational procedures and keep detailed and accurate records for each batch of products manufactured and each batch of raw material used. Batch manufacturing records shall be kept until clinical trials are completed, or until at least two years after the product is completed, whichever period is longer.

Where Chinese herbal medicine factories produce Chinese herbal medicine for use in clinical trials, aforesaid Chinese herbal medicine, in addition to complying with regulations governing labeling in the Act, must also be labeled “for use in clinical trials only,” and marked with the name of the party that commissioned the clinical trial and a trial code sufficient to identify the trial location and research personnel involved. However, where pharmaceuticals for use in clinical trials are tested in closed trials (double-blind trials), drug name, potency and efficacy may be replaced by product codes, serial numbers and packaging batch numbers.

Chinese herbal medicine factories shall determine suitable expiration dates for Chinese herbal medicine for use in clinical trials based on the product properties, container characteristics and storage conditions; the expiration dates marked on aforesaid Chinese herbal medicine may not exceed the expiration dates marked on the original product packaging.
Where clinical trials do not provide stability testing information, the usage period of a repackaged product may not exceed 25% of the remaining portion of the usage period of the original bulk product, or the six-month period following repackaging, whichever period is shorter.

Where a Chinese herbal medicine factory has a Chinese herbal medicine for use in clinical trials manufactured or tested on a contract basis, aforesaid contract shall clearly state that the product in question is for use in clinical trials only.

Where Chinese herbal medicine factories destroy Chinese herbal medicine for use in clinical trials, destruction of aforesaid Chinese herbal medicine may not take place until all clinical trials and the final report are completed; detailed records shall be kept of the destruction process, and aforesaid records shall be preserved by the manufacturer.