临床2期/3期相关的GMP指南或法规

beiwei5du

各位蒲友：

想咨询一下2008年后FDA是否有出具过关于临床2期，临床3期的相关GMP应用的指南和法规呢？？？因为有看到FDA在2008年生效《Guidance for Industry CGMP for Phase 1 Investigational Drugs 》中提及到
We are considering issuing additional guidance and/or regulations to clarify FDA's expectations with regard to fulfilling the CGMP requirements when producing investigational drugs for phase 2 and phase 3 clinical trials.
但是暂时没有找到相关的指南和法规，非常谢谢！！
（注：是2008年后制定的，非现行的PART 210/211以及1991年版的Preparation of Investigational New Drug Products (Human and Animal)）

beiwei5du

(Comment 23) Two comments express concern regarding the effect of the companion guidance on the 1991 guidance on preparation of INDs, which recommends the application of certain sections of parts 210 and 211 to phase 2 and phase 3 clinical trials. The comments also request that FDA clarify the status of the 1991 guidance for phase 2 and phase 3 materials with regard to complying with CGMP requirements. Another comment asks if FDA expects an incremental application of CGMP for the production and testing of phase 2 and phase 3 clinical supplies, or if the 1991 guidance will remain in effect for phase 2 and phase 3 materials until the new phase 2 and phase 3 guidance document is available.
(Response) As stated in the introduction of the companion guidance, the companion guidance will replace the 1991 guidance only as it applies to phase 1 investigational drugs. This action does not affect the scope of the 1991 guidance as it applies to phase 2 and phase 3 investigational drugs, which remains in effect until superseded by a subsequent guidance document.
https://www.fda.gov/ohrms/dockets/98fr/oc07114.pdf