This E-learning courses are organized for regulators only.
Registration is necessary in advance.
Class: Review
- Regulation and Review Process of OTC Drug
- Kampo medicines and Non-Kampo crude drug products
- Roles of Japanese Pharmacopoeia (JP)
- Policies involved in preparation of JP drafts
- Non-Pharmacopoeial Crude Drug Standards
- Characteristics of Natural Medicines
- Approval Standards for OTC Kampo medicines
- Approval Standards for OTC single crude drug preparations
- Role of Prefectural Authorities on approval review
- Steps to obtain marketing approval in Toyama Prefecture
- Review process adapting Approval Standards for OTC Kampo Medicines