06/07/2020
What is Generic drug?
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance.[1][2] A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.
ジェネリック医薬品(後発医薬品)とは？
新薬(先発医薬品)の再審査期間、物質(成分)特許期間満了後、新薬と効き目が同等であることを証明する様々な試験、①規格試験(原薬・製剤の品質確保)、②安定性試験(加速・長期保存)、③生物学的同等性試験(溶出試験、ヒトBE試験)を実施し、厚生労働省の承認を得て製造・販売する医薬品のことです。
Source :
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of....
