Traditional Medicines and OTC Products
A brief overview of the situation regarding traditional medicines and OTC products in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Traditional, herbal, complementary, or alternative medicines and devices are subject to the PMD Act.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
If such traditional, herbal, complementary or alternative products are not prescription medicine, then they can be advertised directly to the public.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
False, exaggerated and misleading advertisement and off-label advertisements are prohibited, as are advertisements that cause fear.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
Over-the-counter medications are also governed by PMD Act. OTC products are subject to Marketing Authorization approval with less strict data requirements compared to prescription medicine, but depending on the nature of the product.
5. Are there any limitations on locations or channels through which OTC products may be sold?
OTC products can be sold at a place where pharmacist is available such as pharmacies and drug stores. OTC products are categorized basically into three types. Type one can only be sold where a pharmacist is available. Category two and three can be sold if a licensed person (non-pharmacist) is available. OTC products, other than special products such as switch OTC products, can also be sold via internet.
6. What health, advertising, and marketing claims may be made for OTC products?
False, exaggerated and misleading advertisements and off-label advertisements are prohibited, as are advertisements that cause fear.
7. Can OTC products be marketed or advertised directly to the public?
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
Conversion of a prescription-only product to an OTC product is called “switch OTC”. A prescription-only product can be switched to OTC if such product is used in the market for a long time with no severe adverse events. Switch OTC products are under strict control, in general, for three years after switch such that it cannot be sold via internet.
9. What are the requirements for the importation of either traditional medicines or OTC products?
There is no specific importation rule for traditional medicines or OTC products and are subject to the same rules under PMD Act.