International Conference on Harmonisation; guidance on Q8(R1) Pharmaceutical Development; addition of annex; availability. Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q8(R1) 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 ICH Q8(R1) guidance includes the previously published parent guidance entitled "Q8 Pharmaceutical Development" (Q8 parent guidance) (71 FR 29344; May 22, 2006) and a newly added annex. The annex provides further clarification of key concepts outlined in the Q8 parent guidance and describes the principles of quality by design (QbD). The annex is intended to show how concepts and tools (e.g., design space) outlined in the Q8 parent guidance could be put into practice by the applicant for all dosage forms.
D002626:Chemistry, Pharmaceutical / Q000592:standards*; D003226:Congresses as Topic; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D007390:International Agencies; D007391:International Cooperation; D007564:Japan; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration