Rubrik: Ausland
(Treffer aus pharmind, Nr. 01, Seite 84 (2019))
Wittner**These authors contributed equally to this work. M | Theisen** D | Metzner B
The Asia Pacific Region / Part 2: CMC Requirements during New Drug Application and Post-Approval Life-Cycle-Management in ASEAN Member States*Part 1 of this series see Pharm. Ind. 2018;80(3):391–397. · Wittner
**These authors contributed equally to this work. M, Theisen** D, Metzner B · Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/Riß
Part 2 is the second article in a series discussing requirements on Chemistry, Manufacturing and Control (CMC) of New Drug Applications (NDAs) and Post-Approval Life-Cycle-Management in the Asia Pacific Region and focuses on requirements within the Association of Southeast Asian Nations (ASEAN). Established in 1967 by five original members, ASEAN comprises ten member states (i.e. Malaysia, Indonesia, Thailand, the Philippines, Singapore, Brunei, Vietnam, Laos, Cambodia, and Myanmar) seeking to promote cooperation to accelerate economic growth and improve competitiveness through elimination of trade barriers and establishment of the ASEAN Free Trade Area (AFTA). AFTA has a population of 622 million people and a ...