This webinar focused on current and emerging regulatory activities in Japan related to the use and approval of excipients, including:
1. Definition of pharmaceutical excipients described in the JP XVIII
2. Japanese Pharmaceutical Excipients Directory (JPED)
3. Official compendia related with pharmaceutical excipients (JP, JPE, JPC, JSQI, JSFA)
4. Drugs exempted from approval in the Japanese Pharmacopoeia (JP)
5. Accreditation of foreign manufactures
6. Cases where JP materials other than “drugs exempted from approval” are used as excipients
7. Atypical actives in Japan
8. Premixed excipients and co-processed excipients
9. ICH Q3 Requirements
> Q3C Residual solvents
> Q3D Elemental Impurities
Learning/Awareness Objectives
> Japanese Pharmacopoeia (JP) definition of pharmaceutical excipients
> JPED contents – Approved excipients in Japan and the administration route and Maximum level per day
> JP and other official compendia legal status
> “Drugs exempted from approval” in the Japanese Pharmacopoeia (JP)
> Overview for manufacturing and distribution of excipients in Japan
> Accreditation of foreign manufacturers
> Japan’s regulations and/or position for: atypical actives, pre-mixed and/or co-processed excipients, residual solvents and elemental impurities
> Handling of New Excipients
> Drug Master File (MF) system
Who should attend?
> Excipient manufacturers, users, distributors
> Regulatory affairs
> Compendial affairs
> Quality affairs