(i)medical technology that uses processed cells (excluding technology that uses only regenerative medicine products (meaning regenerative medicine products approved pursuant to Article 23-25 or Article 23-37 of the Act on Pharmaceuticals and Medical Devices; the same applies below in this Article) as processed cells for approval uses and conditions (meaning usage, dosage, method of use, efficacy, effect, and performance; the same applies below in this item), or for uses and conditions specified by Order of the Ministry of Health, Labour and Welfare as posing the same or lower risk to human life and health as the approval uses and conditions); and

(ii)medical technology that uses nucleic acids and related compounds (excluding technology that uses only pharmaceuticals (meaning pharmaceuticals approved pursuant to the provisions of Article 14 or Article 19-2 of the Act on Pharmaceuticals and Medical Devices; the same applies below in this Article) or regenerative medicine products as nucleic acids and related compounds for the approved uses and conditions (meaning the usage, dosage, efficacy, and effect in the case of pharmaceuticals, and the usage, dosage, method of use, efficacy, effect, and function in the case of regenerative medicine products; the same applies below in this item), or for uses and conditions specified by Order of the Ministry of Health, Labour and Welfare as posing the same or lower risk to human life and health as the approved uses and conditions).

(i)when the administrator of a hospital, clinic, or institution providing regenerative medicine intending to provide regenerative medicine pursuant to the provisions of Article 4, paragraph (2) (including as applied mutatis mutandis pursuant to Article 5, paragraph (2)) requests an opinion on the provision plan for such medicine, the regenerative medicine committee should examine the plan in light of the provision standards for regenerative medicine and provide an opinion to the administrator regarding whether the treatment should be provided and the matters to be noted in its provision;

(ii)upon receiving a report from the administrator of an institution providing regenerative medicine, pursuant to the provisions of Article 17, paragraph (1), regarding matters concerning the occurrence of any disease, disability, death, or infectious disease suspected to be caused by the provision of regenerative medicine, and finding it necessary, the regenerative medicine committee should provide opinions to the administrator regarding the investigation of the cause of the occurrence and the measures to be taken;

(iii)upon receiving a report from the administrator of an institution providing regenerative medicine on the status of the provision of regenerative medicine pursuant to the provisions of Article 20, paragraph (1), and, if deemed necessary, expressing an opinion to the administrator regarding matters to be noted or improved in the provision of such treatment, or an opinion suggesting that the provision of such treatment should be discontinued; and

(iv)in addition to the cases stated in the preceding three items, when it is deemed necessary to ensure the safety of and bioethical standards for regenerative medicine technologies and the proper provision of regenerative medicine, to provide opinions to the administrator of the institution providing regenerative medicine regarding matters described in the provision plan for regenerative medicine, including the name of the regenerative medicine committee.

(i)the name and address of the applicant, and, if the applicant is a corporation, the name of the representative (or, if the applicant is a non-corporate organization with a designated representative or administrator, the name of the representative or administrator);

(ii)the name of the regenerative medicine committee;

(iii)the names and occupations of the members of the regenerative medicine committee;

(iv)a statement to that effect in cases where the regenerative medicine committee conducts review and other duties exclusively related to a provision plan for class III regenerative medicine;

(v)matters related to the system for conducting review and other duties;

(vi)if any fee is collected for review and other duties, the criteria for calculating the fee; and

(vii)other matters specified by Order of the Ministry of Health, Labour and Welfare.

(i)a document outlining the career histories of the members of the regenerative medicine committee;

(ii)rules concerning the review and other duties of the regenerative medicine committee; and

(iii)other documents specified by Order of the Ministry of Health, Labour and Welfare.

(i)with regard to plans for the provision of class I, class II, and class III regenerative medicine, the committee consists of medical or legal experts and other persons specified by Order of the Ministry of Health, Labour and Welfare who are capable of appropriately carrying out the review and other duties in accordance with the respective provision standards for class I, class II, and class III regenerative medicine;

(ii)the composition of the committee members conforms to the criteria specified by Order of the Ministry of Health, Labour and Welfare, ensuring that it is unlikely to impede the fair implementation of review and other duties;

(iii)the corporation has established a system for properly implementing review and other duties, including methods for conducting these duties, managing information acquired during the process, and maintaining confidentiality;

(iv)when fees are collected for review and other duties, the criteria for calculating the fees conform to those specified by Order of the Ministry of Health, Labour, as reasonable in light of the costs required for those duties; and

(v)beyond what is stated in the preceding items, the applicant meets other criteria specified by Order of the Ministry of Health, Labour and Welfare, as necessary for the proper implementation of review and other duties.

(i)when the person has been sentenced to imprisonment or a more severe punishment, and the sentence has not yet been fully served or has not yet ceased to apply;

(ii)when the person has been sentenced to a fine under the provisions of this Act or other Acts concerning citizens' health and medical care specified by Cabinet Order, and the sentence has not yet been fully served or has not yet ceased to apply;

(iii)if the person is one whose accreditation referred to in paragraph (1) has been revoked pursuant to the provisions of Article 33, paragraph (1), and three years have not yet passed since the date of revocation of the accreditation (this includes a person who was previously an officer of a corporation whose accreditation has been revoked within 60 days prior to the date of notice under Article 15 of the Administrative Procedures Act (Act No. 88 of 1993) relating to the revocation of the accreditation (referred to below as the "date of notice" in this paragraph) (an officer refers to members, directors, executive officers, or any other person equivalent to those who execute the business, including those found to have control over the corporation that is equivalent to or greater than that of members, directors, executive officers, or any other person equivalent to those who execute the business; the same applies in item (vi) and Article 35, paragraph (4), items (i) and (iv)), and for whom three years have not yet passed since the date of revocation of the accreditation; or a person who was previously the representative or administrator of an organization whose accreditation has been revoked within 60 days prior to the date of notice, and for whom three years have not yet passed since the date of revocation of the accreditation); provided, however, that this does not apply if the revocation of the accreditation falls under circumstances specified by Order of the Ministry of Health, Labour and Welfare, whereby it is determined that the revocation should not be considered in the same manner as the revocation described in the main clause of this item, based on factors such as the facts constituting the grounds for the revocation, the status of efforts made by the establisher of the certified committee (as defined in item (i) of the following paragraph) to establish a system for preventing the occurrence of those facts, and the degree of responsibility of the establisher of the certified committee with respect to those facts;

(iv)a person that has filed a notification of discontinuation under the provisions of Article 30, paragraph (1) during the period from the date of notification of the revocation of the accreditation referred to in paragraph (1) under the provisions of Article 33, paragraph (1) to the date of the revocation or the date of the decision not to revoke the accreditation (excluding a person that has reasonable grounds for the discontinuation), provided that it has not been three years since the date of the notification;

(v)when the person has committed a wrongful or significantly unjustifiable act in relation to the review and other duties within three years prior to the application for accreditation referred to in paragraph (1);

(vi)a corporation whose officers fall under any of the preceding items; or

(vii)a non-corporate organization whose representative or administrator falls under any of items (i) through (v).

(i)the name and address of the person who has been authorized (referred to below as the "establisher of the certified committee");

(ii)the name of the regenerative medicine committee related to the accreditation (referred to below as the "certified committee for regenerative medicine"); and

(iii)in cases where the regenerative medicine committee has been authorized to conduct review and other duties exclusively related to the provision plan for class III regenerative medicine, a statement to that effect.

(i)when the accreditation under Article 26, paragraph (1), the approval for changes under Article 27, paragraph (1), or the renewal of the validity period under Article 28, paragraph (2) has been obtained through deception or other wrongful means;

(ii)when the established certified committee for regenerative medicine no longer meets any of the requirements specified in the items of Article 26, paragraph (4) (excluding the requirement stated in item (i) of the same paragraph, except for the part relating to the provision plan for class III regenerative medicine, in cases where the certified committee for regenerative medicine conducts review and other duties exclusively related to that plan);

(iii)when the establisher has come to fall under any of the items listed in Article 26, paragraph (5) (excluding items (iii) and (iv));

(iv)when the establisher has failed to make the report specified in Article 31, paragraph (1), has made a false report, has refused, obstructed, or evaded an on-site inspection under the provisions of the same paragraph, or has failed to respond without legitimate grounds or has provided a false response to the questions under the provisions of the same paragraph; or

(v)beyond what is stated in the preceding items, when the establisher has violated the provisions of this Chapter or any order or disposition issued based on its provisions.

(i)the name and address of the applicant, and, if the applicant is a corporation, the name of its representative;

(ii)the name and career history of the administrator of the manufacturing facility of specific processed cells, specific nucleic acids, and related compounds;

(iii)the type of specific processed cells, specific nucleic acids, and related compounds to be manufactured; and

(iv)other matters specified by Order of the Ministry of Health, Labour and Welfare.

(i)a person whose permission has been revoked pursuant to the provisions of Article 49, if three years have not passed from the date of the revocation (if the revoked party is a corporation, this includes any person who was an officer of the corporation within 60 days prior to the date of the notice under Article 15 of the Administrative Procedure Act concerning the revocation, provided that three years have not passed from the date of the revocation);

(ii)a person who has been sentenced to imprisonment or a more severe punishment, and for whom three years have not yet passed since completing the sentence or ceasing to be subject to its enforcement;

(iii)a person, other than those falling under the preceding two items, who has violated this Act; the Act on the Appropriate Provision of Hematopoietic Stem Cells for Transplantation (Act No. 90 of 2012); the Act on Pharmaceuticals and Medical Devices; other pharmaceutical laws and regulations specified by Cabinet Order; or any disposition based on these laws and regulations, and for whom two years have not elapsed since the date of the violation; or

(iv)a corporation whose officers in charge of its business fall under any of the preceding three items.

(i)the name and address of the applicant, and, if the applicant is a corporation, the name of its representative;

(ii)the name and career history of the administrator of the manufacturing facility of specific processed cells, specific nucleic acids, and related compounds;

(iii)the type of specific processed cells, specific nucleic acids, and related compounds to be manufactured; and

(iv)other matters specified by Order of the Ministry of Health, Labour and Welfare.

(i)when the structure and equipment of the manufacturing facility of specific processed cells, specific nucleic acids, and related compounds under the permission no longer conform to the standards referred to in Article 42;

(ii)when the permitted manufacturer has come to fall under any of the items in Article 35, paragraph (4); or

(iii)beyond the cases stated in the preceding two items, when the recipient of the delivery of goods violates this Act, the Act on the Appropriate Provision of Hematopoietic Stem Cells for Transplantation, the Act on Pharmaceuticals and Medical Devices, other pharmaceutical laws and regulations specified by Cabinet Order, or any disposition based on these Acts.

(i)if the Minister of Health, Labour and Welfare finds it necessary and requests the certified manufacturer to make a necessary report pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, and the certified manufacturer fails to make the report or makes a false report;

(ii)when the Minister of Health, Labour and Welfare finds it necessary and has attempted to have the relevant officials inspect the structure and equipment, or books, documents, and other items, and question the relevant persons at the manufacturing facility of specific processed cells, specific nucleic acids, and related compounds or at the office related to the relevant certification of the certified manufacturer, and the persons have refused, obstructed, or evaded the inspection, or have failed to respond without legitimate grounds or provided false responses to the questions;

(iii)when the certified manufacturer has failed to respond to a request made under the provisions of Article 48 as applied mutatis mutandis pursuant to the following paragraph; or

(iv)when the certified manufacturer has violated any of the provisions of this Act, the Act on the Appropriate Provision of Hematopoietic Stem Cells for Transplantation, the Act on Pharmaceuticals and Medical Devices, other pharmaceutical laws and regulations specified by Cabinet Order, or any of the dispositions based on these.

(i)when the structure and equipment of the manufacturing facility of specific processed cells, specific nucleic acids, and related compounds relating to the notification no longer conform to the standards referred to in Article 42;

(ii)when the notified manufacturer has come to fall under any of the items in Article 35, paragraph (4); or

(iii)in addition to the cases stated in the preceding two items, when the notified manufacturer violates this Act, the Act on the Appropriate Provision of Hematopoietic Stem Cells for Transplantation, the Act on Pharmaceuticals and Medical Devices, other pharmaceutical laws and regulations specified by Cabinet Order, or any disposition issued based on these provisions.

(i)when intending to propose the enactment, amendment, or repeal of the Cabinet Order referred to in Article 2, paragraph (2);

(ii)when establishing, amending, or repealing an Order of the Ministry of Health, Labour and Welfare referred to in Article 2, paragraph (2), item (i) or (ii), paragraph (7) or (8), or an Order of the Ministry of Health, Labour and Welfare that specifies a manufacturing facility of specific processed cells, specific nucleic acids, and related compounds referred to in Article 40, paragraph (1);

(iii)when intending to establish or change the provision standards for regenerative medicine; or

(iv)when intending to issue an order under the provisions of Article 8, paragraph (1) (including as applied mutatis mutandis pursuant to Article 10, paragraph (1)).

(i)a person who applies for the renewal of the permission referred to in Article 36, paragraph (1); and

(ii)a person who applies for the renewal of the certification provided for in Article 36, paragraph (1), as applied mutatis mutandis pursuant to Article 39, paragraph (2).

(i)when a person, in violation of the provisions of Article 4, paragraph (1), provides class I regenerative medicine without submitting a provision plan for class I regenerative medicine, or submits such a plan that omits required information or contains false statements;

(ii)when a person, in violation of the provisions of Article 5, paragraph (1), provides class I regenerative medicine without submitting a revised provision plan for class I regenerative medicine, or submits such a plan that omits required information, or contains false statements;

(iii)when a person has violated an order issued under the provisions of Article 8, paragraph (1) (including as applied mutatis mutandis pursuant to Article 10, paragraph (1));

(iv)when a person has violated the provisions of Article 9 (including as applied mutatis mutandis pursuant to Article 10, paragraph (1));

(v)when a person has provided class I regenerative medicine in violation of the provisions of Article 13; or

(vi)when a person has violated an order issued under the provisions of Article 23, paragraph (2) (limited to the part relating to class I regenerative medicine).

(i)when the person manufactures specific processed cells, specific nucleic acids, and related compounds without obtaining permission, in violation of the provisions of Article 35, paragraph (1);

(ii)when the person violates an order issued pursuant to the provisions of Article 47;

(iii)when the person violates a disposition prohibiting the use of manufacturing facilities that produce specific processed cells, specific nucleic acids, and related compounds under the provisions of Article 48, paragraph (1) (limited to dispositions against permitted manufacturers);

(iv)when the person violates an order issued pursuant to the provisions of Article 48, paragraph (2) (limited to orders issued to permitted manufacturers); or

(v)when the person violates an order issued pursuant to the provisions of Article 49.

(i)when the person provides regenerative medicine, in violation of the provisions of Article 4, paragraph (1), without submitting a provision plan for regenerative medicine, or submits such a plan that omits required information or contains false statements (excluding cases falling under the provisions of Article 60, paragraph (1), item (i));

(ii)when the person provides regenerative medicine in violation of the provisions of Article 5, paragraph (1), without submitting a revised provision plan for regenerative medicine, or submits such a plan that omits required information or contains false statements (excluding cases falling under the provisions of Article 60, paragraph (1), item (ii));

(iii)when regenerative medicine is performed in violation of the provisions of Article 13 (excluding cases falling under the provisions of Article 60, paragraph (1), item (v));

(iv)when the person fails to prepare a record or prepares a false record in violation of the provisions of Article 16, paragraph (1);

(v)when the person fails to preserve records in violation of the provisions of Article 16, paragraph (2);

(vi)when the person violates an order issued pursuant to Article 23, paragraph (2) (excluding the part relating to class I regenerative medicine); or

(vii)when the person fails to report as required under Article 24, paragraph (1) or (2), makes a false report, refuses, obstructs, or evades an on-site inspection under the provisions of paragraph (1) or (2) of the same Article, fails to respond without legitimate grounds, or provides a false response to questions under the provisions of paragraph (1) or (2) of the same Article.

(i)when the person manufactures specific processed cells, specific nucleic acids, and related compounds without making a notification, or makes a false notification, in violation of the provisions of Article 40, paragraph (1);

(ii)when the person violates a disposition prohibiting the use of manufacturing facilities that produce specific processed cells, specific nucleic acids, and related compounds under the provisions of Article 48, paragraph (1) (excluding dispositions against permitted manufacturers);

(iii)when the person violates an order issued pursuant to the provisions of Article 48, paragraph (2) (excluding orders issued to permitted manufacturers);

(iv)when the person violates an order issued pursuant to the provisions of Article 51; or

(v)when the person fails to report as required under Article 52, paragraph (1) or (2), makes a false report, refuses, obstructs, or evades an on-site inspection under the provisions of paragraph (1) or (2) of the same Article (including inspections conducted by the PMDA pursuant to the provisions of Article 53, paragraph (1)), fails to respond without legitimate grounds, or provides a false response to questions under the provisions of Article 52, paragraph (1) or (2) (including questions asked by the PMDA pursuant to the provisions of Article 53, paragraph (1)).