Notice of the State Food and Drug Administration on Soliciting Opinions on the requirements of application materials for the review and approval of drug packaging materials and pharmaceutical excipients (Draft for comments) (2016 No. 3)

Source: CFDA 2016-1-13 to implement the opinions of the State Council on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] 44) No.), simplify the drug approval process, change the packaging materials, containers (hereinafter referred to as drug packaging materials) and pharmaceutical auxiliary materials that are directly in contact with drugs from separate approval to review and approve at the same time when approving the drug registration application, and the food and drug administration has organized the drafting of the requirements for application materials for the review and approval of the association of drug packaging materials and pharmaceutical auxiliary materials (Draft for comments) (applicable to the newly declared drug packaging materials) Materials and pharmaceutical accessories) are now open to the public for comments Please feedback the modification opinions to the General Administration of food and Drug Administration (Department of drug and cosmetic registration) by email before February 15, 2016 Contact person: Hu Yin email: huyin@cfda.gov.cn is hereby announced Annex: requirements for application materials for the related review and approval of drug packaging materials and pharmaceutical excipients (Draft for comments) annex to No 3 Announcement of food and Drug Administration on January 7, 2016.doc