Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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Global Innovative products on Fast Track (GIFT)

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.

Logo

GIFT 혁신제품 신속심사 GLOBAL INNOVATIVE PRODUCTS ON FAST TRACK

Key benefits

Main features
The medicinal products chosen by GIFT program go through the expedited review process whose assessment timeline is shortened to up to 75% of usual review time (120 to 90 working days). GIFT also offers various regulatory benefits and services as follows.
  • 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
The GIFT expands its work in order to encourage the development of new products by updating the status of GIFT designation and clinical results of innovative pharmaceuticals.
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

Scope

Pharmaceuticals (Expedited Review)
  • Medicinal products, which is used to treat a serious and severe disease or a rare disease under subparagraph 1 of Article 2 of the 'Rare Disease Management Act', without existing treatment or with a significant improvement (or predicted to be improved) in efficacy and safety compared to existing treatment
  • Medicinal products for prevention or treatment of infectious diseases with a serious threat to public health, such as the pandemic caused by infectious diseases or bioterrorism (including the outbreak of infectious diseases with a significant concern of pandemic), without existing treatment, or with a significant improvement in efficacy compared to existing treatments, or a novel pharmaceuticals with a completely new mode of action or mechanism
  • New drugs developed by innovative pharmaceutical companies designated and notified by the Ministry of Health and Welfare
  • Combination products of drugs subject to priority review and medical devices

*(Legislation and Regulation)
Article 35-4 of the 'Pharmaceutical Affairs Act'
Article 40-2 of the 'Regulation on Safety of Drugs etc'.
Article 7 of the 'Special Act for promotion of the development and emergency supply of medical products in response to public health crisis'

Advanced Biopharmaceuticals (Expedited Review)
  • Products to treat a serious illness, such as cancer that has no alternative remedy and threatens life
  • Products to treat a rare disease under the 'Rare Disease Management Act'
  • Products for the prevention and treatment in case of a pandemic of infectious diseases spread through bioterrorism and other infectious diseases prescribed in the 'Infectious Disease Control and Prevention Act'.

*(Legislation and Regulation)
Article 36 of the 'Act on the safety of and support for advanced regenerative medicine and advanced biological products'
Article 36 of the 'Regulation on the safety and support for advanced biological products'
Article 21 of the 'Regulation on the approval and review of advanced biological products'

The process of GIFT designation and required submission

The process of GIFT designation The products applied for GIFT designation are reviewed by the Expedited Review Division within 30 working days. To begin the process, an applicant must submit the expedited review application form and the required documentation on the Drug Safety website (nedrug.mfds.go.kr). During the review, the Division may request additional data for supplementation, with a maximum of two requests allowed. If additional time is needed for supplementary data, the submission period may be extended twice, but only for the first request. An advisory committee may be convened for expedited reviews, if considered necessary. When a product finally qualifies for the GIFT program, a notification for expedited review designation will be issued, along with the designation of the product for priority review. Additionally, the designated products will be posted on the MFDS website.
  • Note
    • - Medicinal products subject to GIFT is: biologics, recombinant products, herbal (oriental) medicinal products, and advanced biological products
    • - The products designated by GIFT program are reviewed by Expedited Review Division
    • - The advanced biological products designated by GIFT program as priority are reviewed by Cell and Gene Therapy Products Division
  • For more information, the manuals of the expedited review system is available on the MFDS website.
  • www.mfds.go.kr > Legislation & Useful information > Legislation & Regulation > Guidelines for MFDS officials and the Public (Provided in Korean only)
Required submission
All required data should be submitted for the GIFT designation as follows:
  • - Data to demonstrate the products eligibility for expedited review
  • - Data on the origin or discovery and pharmaceutical development history
  • - Data on manufacturing methods
  • - Data on usage, dosage and efficacy and effectiveness

The status of GIFT (Aug. 30, 2020 – Feb. 8, 2024)

Expedited review designation summary chart

56 products have been designated for expedited review

Number of designated products per category

  • Therapies for serious diseases(including 6 advanced biological products):35
  • Medical products for prevention or treatment of infectious diseases posing risks to public health:8
  • Orphan drugs:8
  • New drugs developed by innovative pharmaceutical companies:5

34 products have been reviewed after designation

Number of approved products per category

  • Chemical drugs:7
  • Biologics:8
  • COVID-19 vaccines:15
  • Herbal medicines:1
  • Advanced biological products:3

Anticancer products take the largest among all designation

Percentage of approved products per therapeutic area

  • Anticancer drugs:51.6
  • COVID-19 vaccines and treatments:48.4
  • Chemotherapeutic agents:2.9
  • Anti-diabetic agents:2.9
  • Cardiovascular medical devices:2.9


GIFT Designation Products
Visual Guide of GIFT

Contact

fastreview@korea.kr