OTC Formulation changes to become easier in KOR

MFDS clarifies criteria for’“minor differences’ to simplify submission requirements

Public notification issued for the revision to approval, notification, and review regulations for pharmaceuticals

Going forward, companies seeking approval for over-the-counter (OTC) drugs that use the same route of administration as an already approved or notified product but differ only in formulation will be required to submit significantly fewer review documents. By establishing specific criteria for what constitutes a ‘minor formulation difference,’ a concept that had previously remained ambiguous, the revision is expected to substantially reduce the burden associated with product development and approval changes for pharmaceutical companies.

The Ministry of Food and Drug Safety (MFDS) announced on the 5th that it had issued a public notice of a proposed amendment to the ‘Regulations on the Approval, Notification, and Review of Pharmaceutical Products.’ The revision was introduced to address shortcomings in the current pharmaceutical approval, notification, and review system while rationalizing existing regulations.

The core objective of the amendment is to streamline the administrative procedure by clearly specifying which supporting documents are required when changing the formulation of OTC drugs.

Previously, if a company sought approval for a new product that had the same route of administration as an already approved or notified drug but differed in formulation, it was required to submit extensive review materials, such as head-to-head trial data or bioequivalence study data.

However, under the revised proposal (Appendix 1), if the difference between the proposed OTC formulation and the existing formulation is considered ‘minor’ and falls within the same specified category, existing data for the drug may be used in place of the required review data.

According to examples provided by the MFDS, eligible formulation changes include: Changes among tablets (plain tablets, sugar-coated tablets, and non-enteric film-coated tablets); capsule formulations; granules and powders; Changes among ointments, creams, gels, topical solutions, and topical powders; Changes among oral liquid formulations (excluding emulsions and suspensions) and syrups; Changes between cataplasms and adhesive patches.

The pharmaceutical industry expects the measure to significantly reduce both development time and costs when diversifying OTC formulations to better align with consumer preferences and improve dosing convenience.

In addition to simplifying formulation-change procedures, the amendment includes a number of broader regulatory rationalization measures.

For medical high-pressure gases such as oxygen, a new exemption provision has been established, allowing safety validation data (long-term stability and accelerated stability study results) to be replaced by prior use cases for already approved or registered products. For orphan drug products whose active pharmaceutical ingredient quality data have already been submitted, multiple specifications for the active ingredient may be listed if it can be demonstrated that they do not affect the quality of the finished pharmaceutical product.

In addition, a new provision stipulates that when only the name of a general test method in an official compendium has changed without any modification to the test procedure itself, the approval or notification will be deemed automatically updated without requiring a separate amendment procedure. In addition, efforts to refine legal terminology into easy-to-understand Korean, such as replacing Japanese-style Chinese characters like ' sujaedoen (recorded)’ with 'sillin(included)’ and ' jeokbu (judgment of suitability)’ with 'judgment of conformity/non-conformity’ were also included

The MFDS will accept public comments on the proposed amendment until August 4, 2026. The revised regulation will take effect immediately upon promulgation and will apply to pharmaceutical products for which manufacturing, marketing, or import approval and notification applications (including amendments) are first submitted after the effective date.