Chapter V. Standards for Documents Submitted in Reexamination etc.

Chapter V. Standards for Documents Submitted in Reexamination etc.: 'Ministerial Ordinance on Good Clinical Practice for Drugs', PMDA Japan

Article 56. Standards for Documents Submitted in Reexamination etc.

The provisions of Articles 4 through 6; Article 7 (excluding Item (1) of Paragraph 3); Article 9; Article 10 (excluding Item (2) of Paragraph 1); Articles 11 through 15; Articles 16 through 23; Article 24, Paragraphs 1 and 2; Article 25; Article 26; and Articles 27 through 55 of this Ministerial Ordinance shall apply mutatis mutandis to the data collection and generation for the documents specified in Article 14-4, Paragraph 4
and Article 14-6, Paragraph 4 of PAA concerning clinical trials on drugs conducted by the person who has been granted approval as specified in Article 14 or Article 19-2 of PAA (including cases where these provisions shall apply mutatis mutandis in Article 19-4 of PAA). In such cases, the following references in the above-mentioned provisions (including their headings) shall be read as follows: "clinical trial" shall be read as "post-marketing clinical study," "protocol" shall be read as "post-marketing protocol," "investigator" shall be read as "post-marketing clinical study investigator," "clinical trial in-country representative" shall be read as "post-marketing clinical study in-country representative," "coordinating investigator" shall be read as "post-marketing clinical study coordinating investigator," "coordinating committee" shall be read as "post-marketing clinical study coordinating committee," "subinvestigator" shall be read
as "post-marketing clinical study subinvestigator," "investigators etc." shall be read as "post-marketing clinical study investigators etc," "sponsor" shall be read as "post-marketing clinical study sponsor," "investigational product storage manager" shall be read as "post-marketing clinical study drug storage manager," "clinical research coordinator" shall be read as “post-marketing clinical research coordinator," and "IRB" shall be read as "post-marketing clinical study IRB," “expert IRB” shall be read as “post-marketing clinical study expert IRB,” “IRB etc.” shall be read as “post-marketing
clinical study IRB etc.” Also, in those provisions (including their headings, but excluding Article 11; Article 16, Paragraphs 1, 2, and 5 through 7; Article 17; and Article 39), "investigational products" shall be read as "post-marketing clinical study drugs," “all or any of” in Article 7, Paragraph 1, Item (2), shall be read as “any of,” “investigational products" in Article 11 shall be read as "post-marketing clinical study drugs supplied in such a state that the subject, post-marketing clinical study investigators etc., or post-marketing clinical research coordinators cannot distinguish the test drug from the comparator (hereinafter referred to as "blinded")," “all or any of”
in Article 12, Paragraph 1, and Article 13, Paragraph 1, shall be read as “any of,” "For clinical trial use only" in Article 16, Paragraph 1, Item (1), shall be read as "For post-marketing clinical study use only," "investigational products" in Paragraphs 1, 2 and 5 through 7 of the same article shall be read as "blinded post-marketing clinical study drugs," “Proposed” in Article 16, Paragraph 2, Item (1), shall be read as “Approved,” “investigational product” in Article 17 shall be read as “blinded post-marketing clinical study drug,” "any event […]specified in Article 80-2, Paragraph 6 of PAA" in Article 20, Paragraphs 2, shall be read as "any event specified in Article 77-4-2 of PAA [limited to those which occurred during the post-marketing clinical
study and which have been specified in Article 253, Paragraph 1, Items (1) and (2), of the Ordinance for Enforcement of the PAA (MHW Ordinance No. 1 of 1961)]," “the date of submission of the first clinical trial notification etc.” shall be read as “the date which the Minister of Health, Labour and Welfare designated when marketing approval is granted to the test drug,” "the Investigator’s Brochure" and "immediately notify the investigator" in Article 20, Paragraphs 3, shall be read as "the package insert" and "immediately notify the post-marketing clinical study investigator," respectively, “the
protocol and the Investigator’s Brochure” in Article 20, Paragraph 4, shall be read as “the post-marketing protocol,” "until the day on which marketing approval of the test drug is obtained (or the day 3 years after the date of notification in the case of a notification pursuant to Article 24, Paragraph 3) or the day 3 years after the date of premature termination or completion of the clinical trial, whichever comes later" in Article 26, Paragraph 1, shall be read as "for 5 years after completion of the reexamination or reevaluation of," “until the day on which marketing approval of the test drug is obtained (or the day of notification in the case of a notification pursuant to Article 24, Paragraph 3 or Article 26-10, Paragraph 3) or the day 3 years after the date
of premature termination or completion of the clinical trial, whichever comes later” in Article 34 shall be read as “until the day of completion of reexamination or reevaluation,” "Clinical Trial Office" in the heading of Article 38 shall be read as "Post-marketing Clinical Study Office," "investigational products" in Article 39 shall be read as "blinded post-marketing clinical study drugs," "notified, or notified by sponsor, pursuant to Article 24, Paragraph 3, that the sponsor has decided not to include the clinical trial data in the application, or notified by the sponsor-investigator, pursuant to Article 26-10, Paragraph 3, that the sponsor-investigator has been informed that the clinical trial data will not be submitted in the application" in Article 40, Paragraph 2, shall be read as "notified," "until the day on which marketing approval of the test drug is obtained (or the day 3 years after the date of notification in the case of a notification pursuant to Article 24, Paragraph 3 or Article 26-10, Paragraph 3) or the day 3 years after the date of premature termination or completion of the clinical trial, whichever comes later" in Article 41, Paragraph 2, shall be read as "until the day of completion of
the reexamination or reevaluation of," and "the protocol and the Investigator’s Brochure" in Article 42, Item (2), shall be read as "the post-marketing protocol."

Ministerial Ordinance on Good Clinical Practice for Drugs', source: Pharmaceuticals and Medical Devices Agency, Japan

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