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Overview of Excipient Laws, Regulations and Best Practices in Japan










Wednesday, September 14, 2022 - 9:00am to 11:00am EDT

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

Learning/Awareness Objectives
1. JP definition of pharmaceutical excipients
2. JPED contents – Approved excipients in Japan and the administration route and Maximum level per day
3. Understanding the legal status for the JP and other official compendia
4. Overview for manufacturing and distribution of excipients in Japan
5. About accreditation of foreign manufacturers
6. Japan’s regulations and/or position for: atypical actives, pre-mixed and/or co-processed excipients, residual solvents and elemental impurities

Who should attend?
> Excipient manufacturers, users, distributors
> Regulatory affairs
> Compendial affairs
> Quality affairs