1. Reason for revision
The Pharmaceutical Affairs Act has been revised (Law No. 20328; promulgated on February 20, 2024; and implemented on February 21, 2025) to prohibit drug manufacturers from applying for a new drug permit or filing a new drug registration for a certain period of time based on clinical trial data submitted at the time of the original product approval; to abolish the re-examination system for new drugs; and to integrate the post-market safety management system into the risk management system.
The revision aims to establish a basis allowing drug manufacturers and importers to change business name or business office location through batch approval or notification without the need for separate applications for changes to individual pharmaceutical product approvals.
2. Main contents
a. Provision of methods of submission and procedures for modification of risk management plans (Article 4 and Article 8 of the draft).
The revision clearly specifies the documents that those who have obtained a drug product permit for which a risk management plan has been established must submit when applying for a modification permit, including the base statutes.
b. Batch processing of approval of changes to drug permits (Article 8 of the draft).
The revision establishes a basis for the approval or notification of changes together with changes to drug items when a drug manufacturer or importer applies for a change in the manufacturing business (or importing business) of drugs due to the change of business name or business office location.
c. Provision of drugs whose data are protected and those whose data are to be disclosed (Newly established Article 21-2 of the draft).
The revision stipulates the drug products whose data are to be protected based on the Prime Minister's Decree as provided under the Pharmaceutical Affairs Act, and also stipulates as disclosure items the product name, company name, and data protection period of drugs whose data are protected.
d. Provision of items for which risk management plans must be submitted (Newly established Article 23-2 of the draft).
The revision provides the drugs for which the Prime Ministerial Decree stipulates that a risk management plan must be developed as prescribed under the Pharmaceutical Affairs Act.
