Contains Nonbinding Recommendations
Draft — Not for Implementation 包含不具约束力的建议 草案 — 不用于实施
对所宣称的疗效的影响，来自于动物疾病模型的非临床数据或体外测定药理学数据将是有用的。
VII.?NDAS?FOR?BOTANICAL?DRUG?PRODUCTS?VII．植物药品新药申请?
The pre-NDA meeting is of particular importance for botanical drug products, given their unique characteristics and considerations. The pre-NDA meeting should be held sufficiently in advance of (e.g., more than 2 months before) the planned NDA submission to allow the applicant enough time to meaningfully respond to the Agency’s feedback. In accordance with the Prescription Drug User Fee Act (PDUFA V) performance goals,35 the Agency and applicant will agree on the content of a complete application for the proposed indication(s) at the pre-NDA meeting. Agreements and discussions will be summarized at the conclusion of the meeting and reflected in the Agency’s meeting minutes.
考虑到植物药品的特性和注意事项，对于植物药品，新药申请前会议（the pre-NDA meeting）尤为重要。新药申请前会议应在计划的新药申请提交前足够提前（例如，提前超过2个月），使得申请人由足够时间对FDA的反馈做出回复。为符合处方药生产商付费法案（the Prescription Drug User Fee Act，PDUFA V）所规定的绩效目标，35FDA和申请人应在新药申请前会议上就针对提出的适应症的完整申请达成一致。会议结束时总结达成一致和讨论内容，并以FDA会议纪要形式反映。
Submission requirements for an NDA for a botanical drug product are generally no different from those for other drug products. For instructions and advice on submitting NDAs (applicable to all drug products), the applicant should refer to existing Agency regulations and FDA guidances. The applicant should submit an NDA for a botanical drug product in the Electronic Common Technical Document (eCTD) format. 36 Issues specific to NDAs for botanical drug products are discussed in this section. Refer to previous sections of this guidance for details on data to be acquired and the studies to be conducted to collect such data during the