Japan Regulatory News Alert - August 2004

---

Present regulations in Japan divide pharmaceutical products into drugs (prescription only and OTC) and s.c. quasi-drugs. While drugs can be purchased only at pharmacies and drugstores - where a qualified pharmacist is present, the quasi-drugs can be sold at any other type of store. Quasi-drugs are defined as having "mild action on human body" and a limited (fixed) use, thus permitting the general public to purchase and apply them without professional guidance.  In this latest round of deregulation the Japanese regulatory authorities have changed the approval category of totally 371 products to quasi-drugs, what permits their retail in 24-hour convenience stores, supermarkets and many other general type sales outlets.

The deregulation step has been carried upon the final recommendation of the experts from the Working Group on the "Selection of Medicines without Major Safety Issues". The current selection of 371 products falling into 15 categories has been made after reviewing of some 13,000 OTC drugs (in 85 different categories) presently approved in Japan.

The main implication for the manufacturers and importers would be a much wider access to the general population of Japan, the opportunity to establish or expand their brands - critical for the new entrants to Japan, and to achieve higher sales in shorter period.

Other important implication stems from the considerably relaxed rules for advertisement, communication and promotion of quasi-drugs.

Manufacturers and importers planning to make the OTC-to-quasi-drugs switch are given 1 year to comply with the requirements for precautions for use, warnings, directions, etc. to be printed on the outer containers or wrappers of the quasi-drug products.