What is GIFT?
The GIFT program aims to promote the expedited regulatory review of “global innovative products” in order to facilitate the market launch of innovative medicinal products for treatment of life-threatening or serious diseases such as cancers, or rare diseases, thereby assuring the faster supply of the products to patients.
GIFT is one of the MFDS top 100 projects to achieve regulatory overhaul for excellency and efficiency in food and pharmaceutical industries.What does GIFT mean?
- - 'GIFT' stands for 'Global Innovative products on Fast Track'.
- - It also implies the meaning of the word, 'gift'.
- ➀ The GIFT provides gifts of medicinal products recognized for their innovation in new treatment areas.
- ➁ The GIFT provides treatment opportunities to patients as a gift as early as possible through rapid assessment.
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Key benefits
Main features
- Designation of medicinal products in early stages of clinical development
- Post-approval submission permitted for certain data not directly related to the product's safety
- Rolling review process to shorten the timeline since the review process is able to begin when only part of the data becomes available
- Regulatory supports through close communication channels including product briefing and explanation of supplementation for each application
Major changes
- As-is
- Shortening the assessment timeline for expedited products
- Submitting a full submission package by regulations
- Time gaps between global harmonized regulations and domestic legislations
- Undisclosed designated product lists to the general public
- To-be
- Provide active supports and discovering promising products in an early stage of clinical development in addition to shorten assessment timeline
- Allow the post-approval submission when the data are not directly related to safety, but a full submission package is still required
- Adopt internationally harmonized regulations concurrently to avoid potential regulatory conflicts with foreign regulations
- Open to the public the GIFT designated product lists and their updating status on the MFDS website