Global Innovative Products on Fast Track (GIFT) is a program launched by the Ministry of Food and Drug Safety (MFDS), South Korea, to expedite the review of innovative pharmaceuticals. The program supports the accelerated Regulatory evaluation of “global innovative products” to hasten the market launch of innovative medicinal products intended for the treatment of life-threatening/serious diseases. Thus, its primary aim is to provide patients with a faster supply of innovative products and, in turn, save them from critical illnesses.

Key Advantages of the GIFT Program

The duration of the Regulatory review process is significantly shortened for GIFT-designated products. Additionally, the program provides the following types of Regulatory support:

  • A product is designated for expedited assessment during its early clinical development stage.
  • The rolling review approach prioritizes the Regulatory evaluation of prepared and available information and data first.
  • GIFT-designated products can save the time taken for Regulatory review by 75%, as compared to the typical processes.
  • To minimize Regulatory conflicts with international authorities, global review standards, including those outlined in the ICH guidelines, are used concurrently. The parallel application of internationally harmonized requirements to Regulatory evaluation and the authorization of new products aid in expediting product approval and market launch in overseas markets.
  • Once a product is approved, it is acceptable to submit data that are not directly connected to product safety.
  • The Regulatory reviewer works closely with the developing company to give Regulatory Affairs (RA) consultation and review schedules, including product briefing and guidance on supplements.

Product Scope for GIFT Designation

  • A medicinal product that is meant to cure life-threatening/serious disorders, such as malignancies or rare diseases, which do not have an existing treatment or a product that shows considerable improvement in terms of efficacy over the present treatment is eligible for GIFT designation.
  • A medicinal product that can be used to prevent or treat infectious diseases posing a serious threat to public health, such as those caused by bioterrorism or pandemics, falls under the scope of the GIFT program. Moreover, GIFT is also applicable for a novel product with significantly improved efficacy over existing treatments or with a completely different mode of action/mechanism.
  • The Ministry of Health and Welfare (MHLW) has approved and notified a new medication created by an innovative pharmaceutical company.
  • A combination of a medical device and a medicinal product is eligible for accelerated evaluation under the GIFT program.

The Legal Basis for Eligibility under GIFT

A medicinal product needs to fall under these legal frameworks to be eligible for the GIFT program:

  • Article 35-4 (Priority Review Designation) of the Pharmaceutical Affairs Act
  • Article 40-2 (Priority Review Designation) of the Rules of Pharmaceutical Safety
  • Article 7 (Priority Review) of the Special Act on Promoting the Development and Emergency Supply of Medicinal Products for Public Health Emergency Preparedness

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