International Conference on Harmonisation; Guidance on Q8 Pharmaceutical Development; availability. Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q8 Pharmaceutical Development." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes the suggested contents for the pharmaceutical development section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The guidance also indicates areas where the provision of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches.
D002626:Chemistry, Pharmaceutical / Q000331:legislation & jurisprudence*; D003226:Congresses as Topic; D004282:Documentation / Q000379:methods*; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation / Q000331:legislation & jurisprudence*; D007564:Japan; D014481:United States; D014486:United States Food and Drug Administration