Supplementary Provisions

'Ministerial Ordinance on Good Clinical Practice for Drugs', PMDA Japan

 

Article 1. Effective Date

This Ministerial Ordinance shall come into effect as from April 1, 1997.

Article 2. Interim Measures Concerning Standards for Documents Submitted in Product Application

1. With regard to the documents stipulated in Article 14, Paragraph 3 of PAA, when the relevant data have already been collected or generated, or are being collected or generated, at the time of the implementation of this Ministerial Ordinance, "the provisions of the following article through Article 55" in Article 3 shall be read as "the provisions of Article 30, Paragraph 1; Article 35; Article 44; Article 47, Paragraph 1; Article 50, Paragraphs 1 and 2, and the provisions of Article 67 of the Ordinance for Enforcement of the Pharmaceutical Affairs Act (MHW Ordinance No. 1 of 1961) prior to revision by Article 1 of the Ministerial Ordinance to Partially Revise the Ordinance
for Enforcement of the Pharmaceutical Affairs Act (MHW Ordinance No. 29 of 1997), etc.," and "obtain written informed consent from the subject appropriately" in Article 50, Paragraph 1, shall be read as "obtain informed consent from the subject appropriately."

2. With regard to the documents stipulated in Article 14, Paragraph 3 of PAA, when the relevant data were collected or generated in sponsor-initiated clinical trials under Article 80-2, Paragraph 1 of PAA, for which the request was submitted by June 30, 1997, or in clinical trials whose protocols were submitted pursuant to Paragraph 2 of the same article by the same day (excluding the data specified in the preceding paragraph), "the next article" in Article 3 shall be read as "the next article through Article 6, Article 7 (excluding Paragraph 1, Item (9)), Articles 8 through 12, Article 13 (excluding Items (9) to (13) and Item (15)), Article 14, Article 15, Article 16 (excluding Paragraph 6), Articles 17 through 20, Articles 24 through 27, Article 28, Paragraphs 2 and 3, Articles 29 through 35, Article 38, Articles 40 through 50, Article 51 (excluding Paragraph 1, Item (10)) and Article 52."

3. With regard to the documents stipulated in Article 14, Paragraph 3 of PAA, when the relevant data were collected or generated in sponsor-initiated clinical trials under Article 80-2, Paragraph 1 of PAA, for which the request was submitted by March 31, 1998, or in clinical trials whose protocols were submitted pursuant to Paragraph 2 of the same
article by the same day (excluding the data specified in Paragraph 1 and the preceding paragraph), "the next article" in Article 3 shall be read as "the next article to Article 6, Article 7 (excluding Paragraph 1, Item (9)), Articles 8 through 12, Article 13 (excluding Items (12) and (15)), Articles 14 through 20, Articles 24 through 27, Article 28, Paragraphs 2 and 3, Articles 29 through 35, Articles 38 through 50, Article 51 (excluding Paragraph 1, Item (10)) and Article 52."

Article 3. Interim Measures Concerning Standards for Documents Submitted in Reexamination, etc.

1. With regard to the documents stipulated in Article 14-4, Paragraph 4 and Article 14-5, Paragraph 4 of PAA, when the relevant data were collected or generated in post-marketing clinical studies, for which the request was submitted by June 30, 1997, the following references in Article 56 shall be read as follows: “Paragraph 3, Item (1)" shall be read as "Paragraph 1, Item (9) and Paragraph 3, Item (1)," "Articles 11 through 16" shall be read as "Article 12, Article 13 (excluding Items (9) through (13) and Item
(15)), Article 14, Article 15 and Article 16 (excluding Paragraph 6)," "Article 23" shall be read as "Article 20," "Article 25" shall be read as "Articles 25 through 27; Article 28, Paragraphs 2 and 3; Articles 29 through 35; Article 38; Articles 40 through 50; Article 51 (excluding Paragraph 1, Item (10)); and Article 52."

2. With regard to the documents stipulated in Article 14-4, Paragraph 4 and Article 14-5, Paragraph 4 of PAA, when the relevant data were collected or generated in post-marketing clinical studies, for which the request was submitted by March 31, 1998 (excluding the post-marketing clinical studies specified in the preceding paragraph), the following references in Article 56 shall be read as follows: “Paragraph 3, Item (1)" shall be read as "Paragraph 1, Item (9), and Paragraph 3, Item (1)," "Article 11" shall be read
as "Articles 11 and 12, Article 13 (excluding Items (12) and (15) ) and Article 14," "Article 23" shall be read as "Article 20," "Article 25" shall be read as "Articles 25 through 27; Article 28, Paragraphs 2 and 3; Articles 29 through 35; Articles 38 through 50; Article 51 (excluding Paragraph 1, Item (10) ); and Article 52."

Article 4. Interim Measures Concerning Standards Specified in MHW Ordinance under Article 80-2, Paragraph 1 of PAA

1. When clinical trial protocols conforming to the provisions of Article 7, Paragraph 1 (excluding Items (2) to (4) and Items (9) through (13) ) have already been prepared at the time of implementation of this Ministerial Ordinance, notwithstanding the provisions of Article 57, the provisions of  Article 67 (excluding Items (7) to (11) ) of the Ordinance for Enforcement of Pharmaceutical Affairs Act (MHW Ordinance No.1, 1961; referred to as "the former Ordinance for Enforcement" in Article 6 of the Supplementary Provisions) prior to revision by Article 1 of the Ministerial Ordinance to
Partially Revise the Ordinance for Enforcement of the Pharmaceutical Affairs Act (MHW Ordinance No. 29 of 1997) shall apply to sponsoring clinical trials under Article 80-2, Paragraph 1 of PAA.

2. When the provisions of Article 57 apply to clinical trials whose protocols were submitted pursuant to Article 80-2, Paragraph 2 of PAA between April 1 and June 30, 1997 (excluding the clinical trials specified in the preceding paragraph), "Items (11) and (13)" in Article 57 shall be read as "Item (9)."

3. When the provisions of Article 57 apply to clinical trials whose protocols were submitted pursuant to Article 80-2, Paragraph 2 of PAA between July 1, 1997 and March 31, 1998 (excluding the clinical trials specified in Paragraph 1), "Items (11) and (13)" in Article 57 shall be read as "Item 11)."

Article 5. Interim Measures Concerning Standards Specified in MHW Ordinance under Article 80-2, Paragraph 4 of PAA

1. When clinical trial protocols conforming to the provisions of Article 7, Paragraph 1 (excluding Items (2) through (4) and Items (9) through (13)) have already been prepared at the time of implementation of this Ministerial Ordinance, the provisions of Article 30, Paragraph 1; Article 35; Article 44; Article 47, Paragraph 1; and Article 50, Paragraphs 1 and 2, shall apply to persons conducting the sponsor-initiated clinical trials under Article 80-2, Paragraph 4 of PAA, notwithstanding the provisions of Article 58. In such
cases, "written informed consent from the subject by appropriately explaining in writing" in Article 50, Paragraph 1 shall be read as "informed consent from the subject by appropriately explaining."

2. When the provisions of Article 58 apply to persons conducting the sponsor-initiated clinical trials under Article 80-2, Paragraph 1 of PAA between April 1 and June 30, 1997, or to persons conducting the sponsor-initiated clinical trials whose protocols were submitted pursuant to Paragraph 2 of the same article by the same day (excluding persons specified in the preceding paragraph), "Article 27" in Article 58 shall be read as "Article 27; Article 28, Paragraphs 2 and 3; Articles 29 through 35; Article 38; Articles 40 through 50 ; Article 51 (excluding Paragraph 1, Item (10)) and Article 52."

3. When the provisions of Article 58 apply to persons conducting the sponsor-initiated clinical trials under Article 80-2, Paragraph 1 of PAA between July 1, 1997 and March 31, 1998 (excluding persons conducting the sponsor-initiated clinical trials specified in Paragraph 1 and the preceding paragraph), "Article 27" in Article 58 shall be read as "Article 27; Article 28, Paragraphs 2 and 3; Articles 29 through 35; Articles 38 through
50; Article 51 (excluding Paragraph 1, Item (10)) and Article 52."

Article 6. Interim Measures for the Standards Specified in MHW Ordinance under Article 80-2, Paragraph 5 of PAA

1. When clinical trial protocols conforming to the provisions of Article 7, Paragraph 1 (excluding Items (2) through (4) and (9) through (13)) have already been prepared at the time of implementation of this Ministerial Ordinance, the provisions of Article 67, Items (7), (8) and (10) of the former Ordinance for Enforcement shall apply to the clinical trial
management under Article 80-2, Paragraph 5 of PAA to be performed by persons sponsoring the clinical trials, notwithstanding the provisions of Article 59.

2. When the provisions of Article 59 apply to persons sponsoring the clinical trials under Article 80-2, Paragraph 1 of PAA between April 1 and June 30, 1997, or to persons sponsoring clinical trials whose protocols were submitted pursuant to Paragraph 2 of the same article by the same day (excluding the persons specified in the preceding paragraph), "Paragraph 7" in Article 59 shall be read as "Paragraphs 6 and 7" and "Article 21, Paragraph 1 and" in Article 59 shall be read as "and."

3. When the provisions of Article 59 apply to persons sponsoring the clinical trials under Article 80-2, Paragraph 1 of PAA between July 1, 1997 and March 31, 1998 (excluding the persons specified in Paragraph 1 and the preceding paragraph), "Article 21, Paragraph 1 and" shall be read as "and."

Supplementary Provisions (MHW Ordinance No. 127 of October 20, 2000) (excerpt)

(Effective Date)

1. This Ministerial Ordinance shall come into effect as from the date of implementation of the Act for Partial Revision of the Cabinet Act (Act No. 88 of 1999) (January 6, 2001).


Supplementary Provisions (MHLW Ordinance No. 36 of March 26, 2001) (excerpt)

(Effective Date)

1. This Ministerial Ordinance shall come into effect as from the date of implementation of the Act on the Arrangement of Acts related to the Use of Information and Communication Technology for the Issuance of Documents (April 1, 2001).

Supplementary Provisions (MHLW Ordinance No. 14 of February 22, 2002) (excerpt)

1. This Ministerial Ordinance shall come into effect as from the date of implementation of the Act for Partial Revision of the Act on Public Health Nurses, Midwives and Nurses (March 1, 2002).

2. Forms as prescribed prior to revision by this Ministerial Ordinance, which exist at the time of implementation of this Ministerial Ordinance, may be, for the time being, used after necessary modification.

Supplementary Provisions (MHLW Ordinance No. 106 of June 12, 2003)

1. This Ministerial Ordinance shall come into effect as from the date of implementation of the provisions of Article 1, Items (1) of the supplementary provisions to the Act for Partial Revision of the Pharmaceutical Affairs Act and the Blood Collection and Donation Services Control Act (July 30, 2003).

2. The provisions then in force shall remain applicable to clinical trials that are being conducted, in accordance with a contract concluded pursuant to Article 12, Paragraph 1 and Article 13, Paragraph 1 of Ministerial Ordinance on Good Clinical Practice for Drugs prior to revision by this Ministerial Ordinance, at the time of implementation of this Ministerial Ordinance.

Supplementary Provisions (MHLW Ordinance No. 172 of December 21, 2004)

Article 1. Effective Date

This Ministerial Ordinance shall come into effect as from the date of implementation of the provisions of Article 2 of the Act for Partial Revision of the Pharmaceutical Affairs Act and the Blood Collection and Donation Services Control Act (April 1, 2005).

Article 2. Interim Measure

Notwithstanding the provisions of Ministerial Ordinance on Good Clinical Practice for Drugs as revised by this Ministerial Ordinance, the provisions then in force shall remain applicable to clinical studies on drugs that have already been conducted or that are ongoing at the time of implementation of this Ministerial Ordinance.ю

Supplementary Provisions (MHLW Ordinance No. 72 of March 31, 2006) (excerpt)

Article 1. Effective Date
This Ministerial Ordinance shall come into effect as from April 1, 2006.

Article 2. Interim Measure

Notwithstanding the provisions of the Ministerial Ordinance on Good Clinical Practice for Drugs as revised by this Ministerial Ordinance (hereinafter referred to as the “New Ordinance” in the next article), the provisions then in force shall remain applicable to clinical studies on drugs that have already been conducted or that are ongoing at the time of implementation of this Ministerial Ordinance.

Article 3.

Notwithstanding the provisions of the New Ordinance, the provisions then in force shall remain applicable to clinical studies on drugs (excluding those falling within the scope of the preceding paragraph), for which protocols (limited to those meeting the provisions of Article 7, Paragraphs 1 through 3 or Article 15-4, Paragraphs 1 through 3 of the Ministerial Ordinance on Good Clinical Practice for Drugs) or post-marketing clinical study protocols (limited to those meeting the provisions of Article 7, Paragraphs 1 through 3 [excluding Paragraph 3, Item (1)] applied mutatis mutandis in Article 56 of
the Ministerial Ordinance on Good Clinical Practice for Drugs prior to revision by this Ministerial Ordinance) have already been prepared at the time of implementation of this Ministerial Ordinance.

Supplementary Provisions (MHLW Ordinance No. 24 of February 29, 2008) (excerpt)

Article 1. Effective Date

This Ministerial Ordinance shall come into effect as from April 1, 2008. However, the revised provisions of Article 20, Paragraphs 2 and 3, the revised provisions of Article 28, Paragraph 3, the revised provisions of Article 31, Paragraph 2 and Article 40, Paragraph 1 (limited to the part adding “and Paragraph 3” after “Article 20, Paragraph 2”), the revised provisions of Article 43, Paragraph 2 and the revised provisions of Article 56,
Paragraph 1 (limited to the part adding “and Paragraph 3” after “Article 20, Paragraph 2”) shall come into effect as from April 1, 2009.

Article 2. Interim Measure

Notwithstanding the provisions of the Ministerial Ordinance on Good Clinical Practice for Drugs as revised by this Ministerial Ordinance (hereinafter referred to as the “New Ordinance” in the following article), the provisions then in force shall remain applicable to clinical studies on drugs that have already been conducted or that are ongoing at the time of implementation of this Ministerial Ordinance.

Article 3.

Notwithstanding the provisions of the New Ordinance, the provisions then in force shall remain applicable to clinical studies on drugs (excluding those falling within the scope of the preceding article), for which protocols (limited to those meeting the provisions of Article 7, Paragraphs 1 to 3 or Article 15-4, Paragraphs 1 to 3 of the Ministerial Ordinance on Good Clinical Practice for Drugs) or post-marketing protocols (limited to those meeting the provisions of Article 7, Paragraphs 1 to 3 [excluding Paragraph 3, Item 1] applied mutatis mutandis in Article 56 of the Ministerial Ordinance on Good
Clinical Practice for Drugs prior to revision by this Ministerial Ordinance) have already been prepared at the time of implementation of this Ministerial Ordinance.

Supplementary Provisions (MHLW Ordinance No. 163 of November 28, 2008) (excerpt)

Article 1. Effective Date

This Ministerial Ordinance shall come into effect as from the date of implementation of the Act on General Incorporated Associations and General Incorporated Foundations (December 1, 2008).

Supplementary Provisions (MHLW Ordinance No. 68 of March 31, 2009)

Article 1. Effective Date

This Ministerial Ordinance shall come into effect as from April 1, 2009.

Supplementary Provisions (MHLW Ordinance No. 161 of December 28, 2012) (excerpt)


Article 1. Effective Date

This Ministerial Ordinance shall come into effect as from the date of promulgation.

Article 2. Interim Measure

1. The provisions then in force shall remain applicable, until June 30, 2014, to the reporting (which refers to the reporting as specified in Article 273, Paragraph 3 of the Ordinance for Enforcement of the Pharmaceutical Affairs Act [hereinafter referred to as the "Ordinance for Enforcement"]; the same shall apply hereinafter) by a person sponsoring a clinical trial (hereinafter referred to as "sponsor") for which the protocol (limited to that which meets the requirements as specified in Article 7, Paragraphs 1 to 3 of the Ministerial Ordinance on Good Clinical Practice for Drugs [hereinafter referred to as the “GCP Ordinance”]) has already been prepared before the implementation of this Ministerial Ordinance.

2. Notwithstanding the provisions of the preceding paragraph, where the reporting by the sponsor under the same paragraph is made by June 30, 2014, the provisions of Article 273, Paragraph 3 of the Ordinance for Enforcement of the Pharmaceutical Affairs Act, as revised by Article 1, (hereinafter referred to as the "New Ordinance for Enforcement") may be applied to such reporting at the discretion of the sponsor.

3. The provisions of Article 273, Paragraph 3 of the New Ordinance for Enforcement shall apply to the reporting by the sponsor under Paragraph 1 as from July 1, 2014.

4. The provisions of Article 273, Paragraph 3 of the New Ordinance for Enforcement shall apply, as from July 1, 2014, to the reporting by the sponsor or sponsor-investigator (which refers to the sponsor-investigator as specified in Article 273, Paragraph 3 of the New Ordinance for Enforcement; the same shall apply hereinafter) of a clinical trial for which the protocol is prepared after the implementation of this Ministerial Ordinance.

5. The reporting by the sponsor or sponsor-investigator under the preceding paragraph that is made by June 30, 2014 shall be deemed as the one specified in Article 273, Paragraph 3 of the Ordinance for Enforcement prior to the revision by Article 1, and the provisions of the same paragraph shall apply to such reporting.

6. Notwithstanding the provisions of the preceding paragraph, the provisions of Article 273, Paragraph 3 of the New Ordinance for Enforcement may be applied to the reporting under the same paragraph at the discretion of the sponsor or sponsor-investigator.

Article 3.

1. The provisions then in force shall remain applicable, until June 30, 2014, to the notification (which refers to the notification under Article 20, Paragraph 2 of GCP Ordinance; the same shall apply hereinafter) by the sponsor of a clinical trial for which the protocol has already been prepared before the implementation of this Ministerial Ordinance.

2. Notwithstanding the provisions of the preceding paragraph, where the notification by the sponsor under the same paragraph is made by June 30, 2014, the provisions of Article 20, Paragraph 2 of the GCP Ordinance, as revised by Article 2, (hereinafter referred to as the “New GCP Ordinance”) may be applied to such notification at the discretion of the sponsor.

3. The provisions of Article 20, Paragraph 2 of the New GCP Ordinance shall apply to the notification by the sponsor under Paragraph 1 as from July 1, 2014.

4. The provisions of Article 20, Paragraph 2 of the New GCP Ordinance shall apply, as from July 1, 2014, to the notification by the sponsor of a clinical trial for which the protocol is prepared after the implementation of this Ministerial Ordinance.

5. The notification by the sponsor under the preceding paragraph that is made by June 30, 2014 shall be deemed as the one specified in Article 20, Paragraph 2 of the GCP Ordinance prior to the revision by Article 2, and the provisions of the same paragraph shall apply to such notification.

6. Notwithstanding the provisions of the preceding paragraph, the provisions of Article 20, Paragraph 2 of the New GCP Ordinance may be applied to the notification under the same paragraph at the discretion of the sponsor under the same paragraph.

Article 4. (Partial Revision of the Ministerial Ordinance on Use of Information and Communication Technology for Document Retention, etc. Conducted by Private Entities, etc. in Accordance with Laws and Regulations under the Jurisdiction of the Ministry of Health, Labour and Welfare)

The Ministerial Ordinance on Use of Information and Communication Technology for Document Retention, etc. Conducted by Private Entities, etc. in Accordance with Laws and Regulations under the Jurisdiction of the Ministry of Health, Labour and Welfare (MHLW Ordinance No. 44, 2005) shall be partially revised as follows.

Under the section of the Ministerial Ordinance on Good Clinical Practice for Drugs as shown in the Appendix 2, “Article 18, Paragraph 2” shall be revised as “Article 18” and “Article 26-4, Paragraph 2” shall be revised as “Article 26-4.” Under the section of the Ministerial Ordinance on Good Clinical Practice for Medical Devices as shown in the Appendix 2, “Article 26, Paragraph 2” shall be revised as “Article 26” and “Article 37,
Paragraph 2” shall be revised as “Article 37.”

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

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