药物临床试验质量管理规范-NMPA2020
第四十五条 试验用药品的供给和管理应当符合以下要求：
（一）申办者负责向研究者和临床试验机构提供试验用药品。
（三）申办者制定试验用药品的供给和管理规程，包括试验用药品的接收、贮存、分发、使用及回收等。从受试者处回收以及研究人员未使用试验用药品应当返还申办者，或者经申办者授权后由临床试验机构进行销毁。
第二十一条 研究者和临床试验机构对申办者提供的试验用药品有管理责任。
（二）试验用药品在临床试验机构的接收、贮存、分发、回收、退还及未使用的处置等管理应当遵守相应的规定并保存记录。
第五十条 监查员的职责包括：
（四）监查员应当核实……临床试验机构对未使用的试验用药品的处置符合相关法律法规和申办者的要求。
4.6.3 The investigator/institution and/or a
pharmacist or other appropriate individual, who is designated by the
investigator/institution, should maintain records of the product's delivery to
the trial site, the inventory at the site, the use by each subject, and the
return to the sponsor or alternative disposition of unused product(s).5.14.3 The sponsor should ensure that written
procedures include instructions that the investigator/institution should follow
for the handling and storage of investigational product(s) for the trial and
documentation thereof. The procedures should address adequate and safe receipt,
handling, storage, dispensing, retrieval of unused product from subjects, and
return of unused investigational product(s) to the sponsor (or alternative disposition
if authorized by the sponsor and in compliance with the applicable regulatory requirement(s)).5.14.4 The sponsor should:(a) Ensure timely delivery of investigational
product(s) to the investigator(s).(b) Maintain records that document shipment,
receipt, disposition, return, and destruction of the investigational product(s)
(see 8. Essential Documents for the Conduct of a Clinical Trial).(c) Maintain a system for retrieving
investigational products and documenting this retrieval (e.g., for deficient
product recall, reclaim after trial completion, expired product reclaim).(d) Maintain a system for the disposition of unused
investigational product(s) and for the documentation of this disposition.
临床试验用药品（试行）-NMPA2022
EU Guidelines to Good Manufacturing Practice Medicinal
Products for Human and Veterinary Use Annex 13 Investigational Medicinal
Products
47. Transfers of investigational medicinal products
from one trial site to another should remain the exception. Such transfers
should be covered by standard operating procedures. The product history while
outside of the control of the manufacturer, through for example, trial
monitoring reports and records of storage conditions at the original trial site
should be reviewed as part of the assessment of the product’s suitability for
transfer and the advice of the Qualified person should be sought. The product
should be returned to the manufacturer, or another authorised manufacturer, for
re-labelling, if necessary, and certification by a Qualified Person. Records
should be retained and full traceability ensured.
Q&A中的语音部分属于个人观点，仅供参考。我会尽可能多的列举出能找到的法规依据作为支持，但如果有漏掉或者不正确的地方，欢迎大家给我留言指正。
