From February 21 2025, a new regulatory data protection system will take effect in South Korea. This will replace the ‘de facto’ data exclusivity that has been provided by the existing drug re-examination system for post-marketing surveillance (PMS).
Background
Basically, drug re-examination serves to identify and monitor the safety data of drugs after marketing authorisation (MA). However, Korea has recognised the de facto data exclusivity in such a manner that during the drug re-examination period, a follow-on company is prohibited from using the efficacy and safety data submitted for the MA of the original drug product to seek MA for the same product. This was only based on the Regulation for Pharmaceuticals Approvals, Notifications and Reviews, which is a notification prescribed by the Ministry of Food and Drug Safety (MFDS).
There has been a need to establish a clearer legal framework in this regard. Furthermore, during the re-examination period, MA holders have to submit safety data, and this may overlap with mandatory data submission according to the risk management plan (RMP), which was introduced in 2015. There has also been another need, therefore: to resolve an issue of duplicated work and to efficiently organise the safety management system after marketing drugs.
In 2024, an amendment to the Pharmaceutical Affairs Act was promulgated to clarify a statutory basis for protecting clinical trial data submitted for MA, and abolish the drug re-examination system while merging its PMS function into the RMP system.
Korea’s new regulatory data protection system
Under the amended Pharmaceutical Affairs Act (Article 31-6), a follow-on company (e.g., a generic or biosimilar company) cannot file an MA application based on clinical trial data (excluding bioequivalence data) submitted for the data-protected drug’s MA during the prescribed data protection period, unless:
The MA holder of the data-protected drug agrees to allow the follow-on company to file an MA application based on its clinical trial data; or
The MFDS acknowledges that an MA application filing by the follow-on company is necessary to effectively respond to a public health crisis according to the Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis.
This new regulatory data protection system treats chemical drugs and biologic drugs equally. The types of data-protected drugs and their data protection periods stipulated under Article 31-6 are as follows:
Types of data-protected drugs | Data protection periods |
An orphan drug | Ten years from the date of MA (an additional year if a paediatric indication is added) |
A new drug | Six years from the date of MA |
A drug for which the submission of new clinical trial data is required due to a significant change to an already-approved drug, such as changes to improve the safety, efficacy, and usefulness of the already-approved drug, as prescribed by the ordinance of the prime minister | Six years from the date of MA based on new clinical trial data |
Other drugs for which the submission of new clinical trial data is required and it is deemed necessary to protect data, as prescribed by the ordinance of the prime minister | Four years from the date of MA based on new clinical trial data |
For implementing the new regulatory data protection system, an amendment to the ordinance of the prime minister has been pre-announced and is also expected to be promulgated and take effect on February 21 2025.
According to the outline of the amendment, the drugs given a six-year data protection period, as described by the ordinance of the prime minister in the above table, are:
Prescription drugs different from already-approved drugs in terms of active ingredient(s) or combination ratio (‘new combination’); and
Prescription drugs different from already-approved drugs in terms of administration route, while containing the same active ingredient(s) (‘new administration route’).
The drugs given a four-year data protection period, as described by the ordinance of the prime minister in the above table, are:
Prescription drugs identical to already-approved drugs in terms of active ingredient(s) and administration route(s) but with clearly different indication(s) added (‘new indication’);
Drugs that have been approved for paediatric dosage and administration under 12 years of age through clinical trials (‘paediatric drugs’); and
Drugs for which the commissioner of the MFDS has determined that data protection is necessary, such as drugs with improved dosage and administration.
The new regulatory data protection will apply to drugs for which MA applications are filed on or after February 21 2025. If the MA applications are filed prior to February 21 2025, the drug re-examination system will apply.
Implications of Korea’s new data protection system
The new regulatory data protection system allows data exclusivity without linkage to the drug re-examination, since it has an independent legal basis. Under the drug re-examination system, the MFDS may exempt the re-examination of certain drugs at its discretion under certain situations. Due to such exemption, the de facto data exclusivity may not be given, even though the drugs are eligible for re-examination. The new system is free from this concern and gives the MA holders certainty of protection. Meanwhile, as PMS is integrated into an RMP, it is expected that MA holders can also avoid duplicate work due to simultaneous implementation of PMS and an RMP.
Furthermore, the new regulatory data protection system is expected to reinforce market exclusivity based on data protection for new drugs and incrementally modified drugs. For example, for an incrementally modified drug with an additional indication that is not clearly different from that of already-approved drugs, or with an improved dosage and administration compared with already-approved drugs, although the submission of new clinical trial data is necessary for obtaining a new or an updated MA, there is no data exclusivity period given under the drug-re-examination system.
However, under the new system, a four-year data protection period is possible for such drugs if the commissioner of the MFDS has determined that data protection is necessary. This protection will be valuable if there is no patent protection due to failure to meet patentability based on the improvement of the drug or failure to file a patent application in a timely manner, and so on.
As such, this new system is likely to serve as an incentive for the development of incrementally modified drugs, leading to enhanced R&D capabilities in the pharmaceutical industry.
