Japan's MHLW Sets Size Requirements For Transdermal Patch Drug Listing
This article was originally published in PharmAsia News
Executive Summary
Regarding price listing for non-steroid anti-inflammation transdermal patches, Japan's Ministry of Health, Labor and Welfare ruled that unless there is a medical need requiring a special size, no new products beyond the current three patch sizes and two tape sizes will be listed. The sizes for patches are 7cm×10cm, 10cm×12cm, 14cm×20cm, the sizes for tapes are 7cm×10cm and 10cm ×14cm. MHLW hopes to reduce inventory burdens and clarify the specifications and requirements for drug approval and price listing. (Click here for more - Japanese language