South Korea includes data exclusivity period for paediatric drugs approved abroad

Home/Policies & Legislation | Posted 10/09/2021 post-comment0 Post your comment

As of 5 May 2021, South Korea has updated the re-examination periods for post-marketing surveillance (PMS) of approved drugs. This now includes a four-year re-examination period for PMS that can now be granted for paediatric drugs approved based on both ‘domestic’ and ‘foreign’ clinical trials. 

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The South Korean re-examination system provides similar protection to data exclusivity in other countries and hence can be described as a de facto data exclusivity period for new drugs and certain prescription drugs.

Under the South Korean system, the re-examination period runs from the time of marketing approval and varies depending on certain criteria. In all but two scenarios, generics companies seeking marketing approval must submit their own safety and efficacy data equivalent to or exceeding the scope of the original approval holder’s data. The exempted scenarios are where the generics company has permission to use data from the original approval holder, or when an application is filed on the condition that the drug product will be approved after expiration of the re-examination period.

As such, during the re-examination period, generics companies cannot rely on the original approval holder’s data to obtain regulatory approval for their product and re-examination acts much like data exclusivity. After the PMS period, it is not necessary for generics companies to submit safety and efficacy data for marketing approval of a generic drug product.

The re-examination period varies from four to 11 years, depending on the type of drug application. The four-year period applies to ‘New Indication’ drugs, identical to those already authorized in terms of active ingredient(s) and administration route(s), but having different indication(s) included, or ‘Other’ drugs determined under the consideration of the Korean Ministry of Food and Drug Safety (MFDS). A six-year re-examination period can be granted for incrementally modified drugs, such those that have a new combination or new administration route. Some drug types such as orphan drugs may be exempted from the re-examination period.

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