CRED Getting the CMC Dossier Right 2018


Case study

Container closure system critical data requirements type of primary packaging material, specification and compliance to relevant regulations any sterilisation methods

10) An application for a new vaginal delivery system containing the new  excipient polyurethane. Data on the production and control have  been presented (excipient master file). The system may be administered with the help of a dedicated device • relevant data requirements?

size, shape, contents, opening mechanism risk of handling in a real world setting?!



Drug product development in 2018 Current situation may be as follows generic drug product BE confirmed with AU innovator drug product API sourced from India (CEP) excipients from mainly China & India

Personal recommendation • always consider scientific advice or protocol assistance where appropriate • training of regulatory experts is essential; make sure you are  aware of the latest regulatory guidance documents and scientific evidence • regulatory experts should actively engage with colleagues e.g.  drug development • accept that assessors are human; they may make mistakes and they may disagree among themselves so dare to disagree with them 382

single manufacturing site in India Country of import into EU: Italy MA‐dosiers meets EU standards • acceptable situation?


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