附則
Supplementary Provisions

(施行期日)

(Effective Date)

第一条この法律は、公布の日から施行する。ただし、第三章から第五章までの規定は、公布の日から起算して三月を超えない範囲内において政令で定める日から施行する。

Article 1This Act comes into effect on the date of promulgation; provided, however, that the provisions of Chapters III through V come into effect on the day specified by Cabinet Order within a period not exceeding three months from the date of promulgation.

(検討)

(Review)

第二条政府は、この法律の施行後三年以内に、臨床研究において中核的な役割を担う医療機関における臨床研究の環境の整備の状況について検討を加え、その結果に基づいて必要な措置を講ずるものとする。

Article 2(1)Within three years after the enforcement of this Act, the government is to review the status of the development of the clinical research environment in a medical institution that plays a core role in clinical research, and take necessary measures based on the results of the review.

2政府は、前項に定める事項のほか、この法律の施行後五年以内に、この法律の施行の状況について検討を加え、その結果に基づいて必要な措置を講ずるものとする。

(2)Beyond what is provided for in the preceding paragraph, within five years after the enforcement of this Act, the government is to review the status of enforcement of this Act and take the necessary measures based on the results of the review.

(薬事法等の一部を改正する法律の施行の日の前日までの間の読替え)

(Replacement of Terms until the Day Preceding the Date of Enforcement of the Act Partially Amending the Pharmaceutical Affairs Act)

第三条この法律の公布の日が薬事法等の一部を改正する法律(平成二十五年法律第八十四号)の施行の日前である場合には、同日の前日までの間における第一条及び第十三条第一項の規定の適用については、第一条中「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」とあるのは「薬事法」と、「、同条第四項」とあるのは「又は同条第四項」と、「又は同条第九項に規定する再生医療等製品をいう」とあるのは「をいう」と、第十三条第一項中「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第十四条、第二十三条の二の五又は第二十三条の二十五」とあるのは「薬事法第十四条」とする。

Article 3If the date of promulgation of this Act is before the date of enforcement of the Act Partially Amending the Pharmaceutical Affairs Act, etc. (Act No. 84 of 2013), concerning the application of the provisions of Article 1 and Article 13, paragraph (1) until the day before the date of enforcement, the term "the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices" in Article 1 is deemed to be replaced with "the Pharmaceutical Affairs Act," the term "paragraph (4) of that Article" is deemed to be replaced with "or paragraph (4) of that Article," the term ", or regenerative medicine products provided in paragraph (9) of that Article" is deemed to be replaced with " , " and the term "Article 14, Article 23-2-5 or Article 23-25 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices" in Article 13, paragraph (1) is deemed to be replaced with "Article 14 of the Pharmaceutical Affairs Act.

(独立行政法人日本医療研究開発機構が成立するまでの間の読替え)

(Replacement of Terms until the Establishment of the Japan Agency for Medical Research and Development, Independent Administrative Agency)

第四条独立行政法人日本医療研究開発機構が成立するまでの間における第二十一条第四号の規定の適用については、同号中「第八条又は」とあるのは、「附則第四条において準用する同法第八条又は同法」とする。

Article 4Concerning the application of the provisions of Article 21, item (iv) until the establishment of the Japan Agency for Medical Research and Development, Independent Administrative Agency, the term "Article 8 or" in that item is deemed to be replaced with "Article 8 of that Act or that Act, as applied mutatis mutandis pursuant to Article 4 of the Supplementary Provisions".