CRED Getting the CMC Dossier Right 2018

03/05/2018

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?!

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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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Thank you for your attention Any Questions? da.v.riet@cbg-meb.nl

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