| Contents | ||
| World wide view on development and evaluation of switched and direct OTC | ||
| Preface | Shimizu N | i |
| ●Overview on development and evaluation on switched and direct OTC from a world wide stand point of self-medication | Shimizu N | 1-19 |
| ●Material [Japanese] & [English] | ||
| 1. Guidance for the development and assessment of “New Nonprescription Drugs” | Shimizu N, et al. | 21-39 |
| 2. A guideline on changing the classification for the supply of a medicinal product | European Commission | 41-56 |
| 3. OTC review －Manual of policies and procedures (MAPP6020.5) | FDA/CDER | 57-87 |
| (Appendix) | ||
| OTC review －Manual of policies and procedures (MAPP6532.1) －OTC labeling and use studies－ | FDA/CDER | 89-96 |
| 4. Comprehension testing for OTC drug labels －Goals, methods, target population, and testing environment－ | Morris L, Lechter K, Weintraub M, et al. | 97-125 |
| 5. Over-The-Counter human drugs；labeling requirements；final rule | FDA/CDER | 127-64 |
| 6. Points to consider for package inserts for OTC Japan, issued by MHW (in Japanese) | 165-8 | |
| ●Instructions for authors [Japanese] & [English] | 169-74 | |