Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律 Iyaku-hin, iryō-kiki tō no hinshitsu, yūkōsei oyobi anzensei no kakuho tō ni kansuru hō ritsu ) is a law regulating the manufacturing, importation, and sale of drugs, medical devices and medical softwares. It was originally passed as Pharmaceutical Affairs Act ( 薬事法 , Yakujihō ) in 1960, and was renamed current title in 2014. It is often abbreviated to Iyaku-hin Iryō-kiki tō hō (医薬品医療機器等法) or yakki hō (薬機法).
6-408: (Redirected from Pharmaceutical Affairs Act ) Pharmaceutical Affairs Law or Pharmaceutical Affairs Act may refer to: Pharmaceutical Affairs Law (Japan) Pharmaceutical Affairs Law (South Korea) Pharmaceutical Affairs Law (Taiwan) Topics referred to by the same term [REDACTED] This disambiguation page lists articles associated with
12-463: A 20% to 40% discount to competing drug stores (including Aeon-affiliated companies). The amendment was expected to put significant competitive pressure on drug stores. However, the law continued to ban internet sales of OTC drugs, which the Ministry of Health had previously justified by stating that drug sales should only be conducted in person by pharmacists or other qualified vendors who could explain
18-502: The side effects of the drugs. On May 24, 2013, the Government Cabinet approved a revision of Pharmaceutical Affairs Law to simplify the approval process for medical devices and regenerative medicine products, the safety of regenerative medicine using iPS cells (stem cells). According to the revised bill, medical equipment can be checked by the private organization including regenerative medicine products and validation of
24-403: The first change in the sales structure of OTC drugs in 46 years. The amended law permitted stores to sell certain over-the-counter drugs without having a pharmacist on staff, opening up the market to convenience stores , supermarkets , and other such stores. 7-Eleven was the first convenience store to take advantage of the amended law, while Aeon supermarkets also began selling OTC drugs at
30-593: The law changed the regulatory structure for pharmaceuticals and medical devices, in an effort to align laws more closely with those in the European Union, Australia, Canada, and the United States. The amendment shifted the focus of regulation from the point of manufacturing to the point of sale , and adopted a risk-based classification system for products. The June 2006 amendment to the law (Law No. 69 of 2006, with effective date of June 2009), represented
36-531: The title Pharmaceutical Affairs Law . If an internal link led you here, you may wish to change the link to point directly to the intended article. Retrieved from " https://en.wikipedia.org/w/index.php?title=Pharmaceutical_Affairs_Law&oldid=806488468 " Category : Disambiguation pages Hidden categories: Short description is different from Wikidata All article disambiguation pages All disambiguation pages Pharmaceutical Affairs Law (Japan) The July 2002 amendment to
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