Evidence map›Paper›PMID 36312539›Full record

ReviewFrontiers in bioengineering and biotechnology2022

Impact and challenges of enactment for advanced regenerative medicine in South Korea.

Dong-Sook Kim, SeungJin Bae

Abstract readReview
In one paragraph

Review in Frontiers in bioengineering and biotechnology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  12. Stem Cell Therapy, the Market, the Opportunities and the Threat.International journal of molecular and cellular medicine · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Dong-Sook KimDepartment of Research, Health Insurance Review and Assessment Service, Wonju, South Korea.
SeungJin BaeCollege of Pharmacy, Ewha Womans University, Seoul, South Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Korean government has enacted the Act on Advanced Regenerative Medicine and Advanced Biological products (ARMAB) in August 2019, and it has been implemented in 2020. We reviewed the changes made by ARMAB compared to the existing Pharmaceutical Affairs Act and discussed future challenges to accelerate regenerative medicine while ensuring safety and efficacy. This act and regulations focused on the key elements of act as follows: the definition of advanced regenerative medicine (RM), the licensing of related facilities, safety management such as long-term follow-up, clinical research review committee, and establishment of a roadmap. Our study shows that Korea has achieved the second highest number of first approvals for regenerative medicine indications worldwide through expedited approvals encouraging innovation, while maintaining patient safety by mandating long-term follow-up. Additionally, the establishment of an interactive system for retrieval of patients' data and reporting of safety information by manufacturers electronically demonstrates Korea's commitment to innovation for Advanced RM and patient safety.

Indexed as

biological productsenactmentregenerative medicinesafetySouth Korea

Identifiers

PMID36312539
PMCPMC9597240

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.