Overview of Excipient Laws, Regulations and Best Practices in Japan

Wednesday, September 14, 2022 - 9:00am

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

Cancellation Policy


Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street N
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you registered and are unable to attend the webinar, a recording of the webinar will be provided.

No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Please contact IPEC-Americas Training Coordinator
571-814-3449 or email ipecamer@ipecamericas.org