1. Reasons for Amendment
The Pharmaceutical Affairs Act was amended (Act No. 19652; promulgated on August 16, 2023; to be enforced on February 17, 2024) to prescribe that the hearing procedure may be omitted when changing registered information in a patent list due to a change in the name of a drug or other minor matters specified by Ordinance of the Prime Minister, and to prescribe an obligation for any person who has obtained permission for preferential distribution of items to report to the Minister of Food and Drug Safety in certain circumstances. This Amendment prescribes matters delegated by the Act and matters necessary for the enforcement thereof, while also modifying forms concerning certification of GMP compliance to require the specific dosage form to be stated, and otherwise addressing and improving upon a number of weaknesses that have emerged from the operation of the current system.
2. Major Provisions
A. Improve regulations concerning the information submitted when applying for permission (Article 4 amended)
Minimize treatment gaps for domestic patients by amending provisions to exempt those who outsource all manufacturing processes from submitting GMP evaluation data and to allow some documents to be substituted with a written explanation when applying for permission for a national essential drug for which there are no alternatives, thereby supporting timely permission.
B. Clarify information to be submitted upon clinical trial protocol approval (Article 24, attached Form 23 amended)
Clearly specify that information necessary to assess whether an investigational product meets drug GMP and investigational product GMP requirements may be submitted upon clinical trial protocol approval.
C. Improve the reporting system for drug supply suspensions (Article 49, attached Table 8 II. subparagraph 27 amended)
Strengthen the effectiveness of the reporting system by prescribing a reporting deadline of 180 days before a suspension of supply, requiring any supply shortage to be reported to enable a preemptive response by the government against drug shortages, and strengthening the standards for administrative disposition for those who fail to file a report.
D. Improve procedures concerning registered information in patent lists (Article 62-4, Article 62-11 amended, attached Form 59-8 newly inserted)
Specify minor matters for which the hearing procedure for interested parties, etc. is not required when making changes to information registered in a patent list, and prescribe document requirements, procedures, etc. when reporting grounds to extinguish the effect of a permission for preferential distribution of items.
E. Modify administrative dispositions concerning safety managers ([Table 8] II. subparagraphs 23 and 29 amended)
Modify the disposition standards that apply when a safety manager is not appointed and when a change or abolition is not reported.
F. Modify forms concerning certifications of GMP compliance (attached Forms 81, 81-2, and 82 amended)
Improve forms for certifications of GMP compliance to require the specific dosage form determined by the Minister of Food and Drug Safety to be stated.
