The Asia Pacific Region

Rubrik: Ausland

(Treffer aus pharmind, Nr. 03, Seite 391 (2018))

Theisen D | Metzner B

The Asia Pacific Region / Part 1: CMC Requirements during New Drug Application and Post-Approval Life-Cycle-Management in Japan · Theisen D, Metzner B · Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/Riß
ACTD – ASEAN Common Technical Dossier AF – Application Form AM – Approved Matters CBE – Changes-being-effected CMC – Chemistry/Manufacturing/Control CPP – Certificate of Pharmaceutical Product CQA – Critical Quality Attributes DMF – Drug Master File DP – Drug Product DS – Drug Substance eCTD – electronic Common Technical Document FMA – Foreign Manufacturer Accredited Certificate ICC – In-Country Caretaker J-CTD – Japanese Common Technical Document J-QOS – Japanese Quality Overall Summary J-NDA – Japanese New Drug Application JP – Japanese Pharmacopoeia MAA – Marketing Authorisation Holder MCN – Minor Change Notification MCM – Minor Change Matter MOU – Memorandum ...