On February 20, 2024, an amendment to the Pharmaceutical Affairs Law ("Amendment") was promulgated, which abolishes the current drug re-examination system and establishes a new system expressly protecting drug data for marketing authorization ("MA"). The Amendment will take effect on February 21, 2025, one year after promulgation.
The purpose of the current drug re-examination system is to monitor the safety and efficacy data of drugs after MA. However, in practice, the system has also served to provide de facto data exclusivity in Korea, since latecomers are prevented from utilizing data submitted for the original drug's MA during the re-examination period for their own approvals.
The Amendment abolishes the current re-examination system, and adds a new provision for an express system of data protection for pharmaceuticals (Article 31-6 of the Pharmaceutical Affairs Law). Under the new provision, a latecomer (such as a generic/biosimilar company) expressly cannot file its MA application based on the clinical trial data submitted for the original drug's MA for a certain period of time ("Data Protection Period"), unless (i) the original drug applicant consents to the latecomer's MA application filing based on the original drug applicant's clinical trial data, or (ii) the Ministry of Food and Drug Safety (MFDS) deems that the latecomer's MA application filing is necessary to respond to a public health crisis.
<Data Protection Period by Drug Type>
| Drug Type | Data Protection Period |
| Orphan drug | 10 years from the date of MA (Additional 1 year if adding pediatric indication) |
| New drug | 6 years from the date of MA |
| Drug requiring submission of new clinical trial data due to a material change to a drug already approved, as prescribed by the Prime Minister's Decree (e.g., changes to improve safety, efficacy and usefulness of a drug already approved) | 6 years from the date of MA |
| Other drugs requiring submission of new clinical trial data and for which the need for data protection is acknowledged, as prescribed by the Prime Minister's Decree | 4 years from the date of updated MA |
The new data protection system under the Amendment covers both chemical and biologic drugs, and will apply to drugs with MA applications filed on or after February 21, 2025. For drugs where the MA application is filed prior to February 21, 2025, the current re-examination system will apply. The original function of the re-examination system to monitor post-marketing safety will be integrated into the Risk Management Plan.
Further updates will be provided as needed regarding MFDS practice developments and/or any subsequent implementing amendments to the relevant subordinate legislation of the Pharmaceutical Affairs Law (including the Prime Minister's Decree).
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