2019年3月19日「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等の一部を改正する法律案」が閣議決定され、国会に提出された。
第198回通常国会での成立はならず、同年10月4日に開会した臨時国会において審議が継続して行われ、11月27日の参院本会議で可決され、成立、12月4日に公布された(以下「改正薬機法」という)。
本改正は、5年前に施行された改正薬事法の附則において、施行後5年を目処として改正後の規程等を検討することとされていたことを受けたものである。
改正薬機法は、関連する企業への規制強化の側面を含んでいるため、今後詳細が定められる省令等の動向を注視する必要がある。
また改正薬機法の改正内容は広範囲かつ多岐にわたり、施行日も内容によって、1年、2年または3年を超えない政令の定める日からとされ、施行時期が異なっている。
「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等の一部を改正する法律の施行期日を定める政令(令和2年3月11日政令第39号)」(2020年3月11日公布)により、施行期日は2020年9月1日、2021年8月1日、2022年12月1日とされた。
GMP省令の改正、QMS省令の改正なども、2020年9月1日の施行に合わせて実施されるのではないかと筆者はみている。
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