(1) Reasons for Proposal
In accordance with the enactment of the Act on the Safety of and Support for High-Tech Regenerative Medicine and High-Tech Biomedicines, this enactment prescribes matters delegated by the Act in relation to the approval and safety control of high-tech biomedicines, and matters necessary for the enforcement thereof.
(2) Major Provisions
A. Establish and operate electronic registers (Article 3 / Non-regulatory / No costs incurred)
- Issue permits, etc., in the form of electronic documents that are easily accessible in real-time without time or space restrictions instead of paper permits; this is not a newly inserted or strengthened provision.
B. Prescribe procedures and methods for cell processing facility permits/change permits/renewals (Articles 4, 5, 6, and 7 / Non-regulatory / No costs incurred)
- The processing of cells that are drug components is a part of pharmaceutical manufacturing. Previously, a person who intended to collect, test, and process human cells, etc., and supply them to medical institutions was required to obtain a drug manufacturing business permission and marketing approval in accordance with Article 31 of the Pharmaceutical Affairs Act. Under the Enforcement Rule, however, such a person is only required to obtain a cell processing facility permit and therefore a regulatory review is not required.
- Article 15 of the Act prescribes that a person who intends to collect, test, process, and supply human cells, etc., shall obtain a permit/change permit/renewal as a cell processing facility Accordingly, these Rules prescribe detailed matters concerning the procedures and methods for handling permits, change permits, closedowns/shutdowns, and renewals, and therefore a regulatory review is not required.
- The provisions require a person who is applying for a cell processing facility permit/change permit/renewal to submit documents to verify the requirements concerning facilities/personnel/equipment as specified by the Act. These regulations are accessory to existing requirements and are not newly inserted or strengthened provisions.
C. Prescribe procedures and methods for high-tech biomedicine manufacturing business permits/contract manufacturing business registration/import business registration/renewals (Articles 8, 9, 14, and 22 / Non-regulatory / No costs incurred)
- The provisions are the same as the procedures and methods for manufacturing business permission under the existing Pharmaceutical Affairs Act. For contract manufacturing businesses, the regulations have been relaxed so that they are no longer required to submit information on clinical trial plans from among the documents required under the Pharmaceutical Affairs Act.
- Articles 23 and 27 of the Act prescribe that a person who intends to operate a manufacturing business, contract manufacturing business, or import business shall file an application with the Ministry of Food and Drug Safety and renew his or her permit or registration certificate every three years. Accordingly, these Rules prescribe detailed matters concerning the procedures and methods for handling manufacturing business permits, contract manufacturing business registration, import business registration, and renewals of business permits/registrations and therefore a regulatory review is not required.
- The provisions require a person who intends to obtain a manufacturing business permission, register a contract manufacturing business or import business, or renew a business permit to submit documents to verify the facility requirements, qualifications, etc., as specified by the Act. The regulations are accessory to existing requirements and are not newly inserted or strengthened provisions.
D. Prescribe procedures and methods for marketing approvals/change approvals for manufactured and imported high-tech biomedicines (Articles 10, 11, 12, 13, 15, and 16 / Non-regulatory / No costs incurred)
- Key matters concerning marketing approvals for manufactured/imported items are set forth in the Act, and the delegated matters are the same as what is prescribed by the Pharmaceutical Affairs Act. Applications for change approvals, business office establishment, and marketing approval exclusion criteria, restrictions, and acceptance criteria are the same as what is prescribed by the Pharmaceutical Affairs Act.
- Article 23, paragraphs 2 and 7 and Article 27, paragraphs 5 and 8 of the Act requires marketing approvals and change approvals to be obtained for manufactured/imported items, and Article 23, paragraph 4 of the Act arbitrarily prescribes that a person who has obtained a marketing approval may establish a business office. Accordingly, these Rules prescribe detailed matters concerning procedures and methods for handling marketing approvals, change approvals, and business office establishment and therefore a regulatory review is not required.
- The provisions require a person who is applying for a marketing approval/change approval for a high-tech biomedicine to submit documents to verify requirements specified by the Act. These regulations are accessory to existing requirements and are not newly inserted or strengthened provisions.
E. Register manufacturing supervisors and import supervisors of high-tech biomedicines (Articles 17 and 23 / Non-regulatory / No costs incurred)
- The Enforcement Rule prescribes the same manufacturing/import supervisor eligibility criteria, approval method, document requirements, and registration method as the Pharmaceutical Affairs Act.
- Article 24 and Article 27, paragraph 5 of the Act prescribes that a high-tech biomedicine manufacturer shall appoint a qualified manufacturing supervisor and accordingly, these provisions prescribe matters concerning the procedure and method for handling manufacturing supervisor approvals and are not newly inserted or strengthened provisions.
F. Obligations of manufacturing supervisors and import supervisors of high-tech biomedicines (Article 18, Article 24 / Non-regulatory / No costs incurred)
- The Enforcement Rule prescribes the same obligations for manufacturing/import supervisors as the Pharmaceutical Affairs Act.
- The document retention period has been changed to 5 years to match subparagraph 4, item A of the “Rules on the Safety of Drugs, etc.” [Attached Table 3] Article 3, paragraph 3 of the “Rules on the Manufacture and Sale Management of Biological Products, etc.” It is not a newly inserted or strengthened provision.
G. Obligations of manufacturers and importers of high-tech biomedicines (Articles 19, 20, 21, and 25 / Non-regulatory / No costs incurred)
- Key matters concerning the obligations of manufacturers and importers of high-tech biomedicines are prescribed in Article 26, paragraph 1 of the Act. The Enforcement Rule prescribes detailed matters at a level equivalent to that of the Pharmaceutical Affairs Act.
- A format, issuing method, and period for certificates of compliance with GMP for biomedicines are prescribed in the same manner as the Pharmaceutical Affairs Act.
- Procedures for reporting the production, export, and import performance of high-tech biomedicines are prescribed in the same manner as the Pharmaceutical Affairs Act.
H. Register offshore production facilities (Article 26 / Non-regulatory / No costs incurred)
- The Enforcement Rule prescribes the same procedure and method for handling offshore production facility registration/change registration/change declaration as the Pharmaceutical Affairs Act.
- In accordance with Article 27, paragraph 7 of the Act, which prescribes that an importer shall register the offshore production facilities of the items that he or she intends to import, the scope, procedure, and method of offshore production facility registration has been prescribed. These provisions have not been newly inserted or strengthened.
I. Prescribe procedures and methods for permits/change permits/renewals of human cell, etc., management services (Article 27, 28, 29, and 30 / Non-regulatory / No costs incurred
- The processing of cells that are drug components is a part of pharmaceutical manufacturing. Previously, it was necessary to obtain a drug manufacturing business permission and marketing approval in accordance with Article 31 of the Pharmaceutical Affairs Act. Under the Enforcement Rule, however, only a human cell, etc., management service permit is required and therefore a regulatory review is not required.
- Article 28 of the Act prescribes that a person who intends to collect, test, and process human cells, etc., and supply them as components of high-tech biomedicines shall obtain a permit/change permit/renewal as a human cell, etc., management service. Accordingly, these Rules prescribe detailed matters concerning the procedures and methods for handling human cells, etc., management service permits, change permits, closedowns/shutdowns, and renewals, and therefore a regulatory review is not required.
- The provisions require a person who is applying for a human cell, etc., management service permit/change permit/renewal to submit documents to verify the requirements concerning facilities/personnel/equipment as specified by the Act. These regulations are accessory to existing requirements and are not newly inserted or strengthened provisions.
J. Obligations for human cell, etc., management service providers (Article 31, Article 32 / Non-regulatory / No costs incurred
- These provisions are non-regulatory as manufacturer obligations previously applicable under the Pharmaceutical Affairs Act are not applicable under the Enforcement Rule.
- The provisions contain detailed matters concerning the obligations of human cell, etc. management services under Article 29 of the Act. They are the same as matters set forth in the current “Good Manufacturing Practice for Drugs” and guidelines, etc., and have not been newly inserted or strengthened.
K. Register long-term follow-up studies and dosing histories of high-tech biomedicines (Articles 33, 34, 35, and 36 / Non-regulatory / No costs incurred)
- Article 30 prescribes that drugs for which it is necessary to check for adverse events for a specified period of time post-dose shall be subject to long-term follow-up and prescribes the formulation of plans, reporting of serious adverse events, registration of subjects eligible for dosing, and sales/supply histories. Accordingly, the delegated matters are prescribed in the subordinate law.
- The Enforcement Rule prescribes the same method of drug monitoring as risk control plans that are operated in accordance with the “Regulations on the Marketing Approval/Examination of Biological Products, etc.” and guidelines, etc. The provisions have not been newly inserted or strengthened.
L. Information stated on the containers/packaging of high-tech biomedicines (Article 37 / Non-regulatory / No costs incurred)
- Article 31 of the Act prescribes key matters to be stated on containers/packaging, and these provisions prescribe detailed matters that have been delegated to subordinate laws.
- These provisions prescribe information to be stated on the containers/packaging of high-tech biomedicines in the same manner as the Pharmaceutical Affairs Act, and have not been newly inserted or strengthened.
M. Guide/supervise the Regulatory Science Center (Article 38 / Non-regulatory / No costs incurred)
- These provisions concern guidance and supervision for affairs delegated to the Regulatory Science Center by the Ministry of Food and Drug Safety. They are not associated with the public obligations or restriction of public rights and therefore are not subject to regulatory review.
N. Applications for classification of items featuring high-tech biotechnology, prompt processing, etc. (Article 39 / Non-regulatory / No costs incurred)
- Regulations have been relaxed to allow applicants to apply for classification in terms of whether an item is a high-tech biomedicine. The provisions prescribe detailed procedures and methods for handling such matters and have not been newly inserted or strengthened.
- Regulations have been improved so that treatments for rare illnesses, cancer, and other serious diseases may be deemed eligible for fast tracking and undergo priority reviews, custom reviews, or receive conditional approval so as to reduce development time. The provisions prescribe detailed procedures and methods for handling such matters and therefore are not subject to regulatory review.
* (Item classification) Determining whether an item is a high-tech biomedicine / (Fast tracking) Designating high-tech biomedicines that aim to treat rare or incurable diseases, etc., for faster handling
* (Custom review) Each development process is reviewed before a developer applies for a marketing approval / (Conditional approval) Approval granted on condition of postmarketing surveillance
