The China Food and Drug Administration ("CFDA") has recently drafted and issued the Implementing Standards for On-spot Inspections for the Registration of Special Foods (Draft for Comment) (the "Draft for Comment") for public consultation by December 5, 2017.
The Draft for Comment applies to on-spot inspections conducted at places where dietary supplements, infant formula milk powders, and foods for special medical purposes are researched, developed, trial-produced, or initially manufactured, and also extended inspections occurring at places where extractives from raw materials and complex nutrients are manufactured. In addition, the Draft for Comment provides that varieties under inspection shall remain being trial produced or manufactured dynamically on the production line when the on-spot inspections are underway, and then will be randomly selected on the site for tests after the production process ends. Infant formula milk powders and foods for special medical purposes shall pertain to the commercialized scale of production, and dietary supplements shall reach the pilot scale of production or above. Furthermore, the Draft for Comment expressly states that results of on-site inspections in respect of the registration of dietary supplements shall be used only as the reference for the relevant production licensing work, not the evidence that the parties concerned could be exempted from future on-spot checks for the production licensing purpose.