Webinar – Overview of Excipient Laws, Regulations and Best Practices in Japan

Wednesday 14 September 2022

For more information and to register!

This webinar will focus 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