Korea MFDS Revises Regulations for Pharma Clinical Trials

-

 

Clinical Trials of Pharmaceuticals
Clinical Trials of Pharmaceuticals

The Korea Ministry of Food and Drug Safety (MFDS) has revised regulations regarding the approval of clinical trial plans for pharmaceuticals.

This notification will take effect from January 16, 2024.


- Allow the submission of non-animal or human biology-based test (cell-based assays, microphysiological systems, bioprinting, computer modeling, etc.) data for non-clinical trial data.



👉 Contact GCA

Tel. +82-31-360-8180
Email: forest.lee@gca-kr.com


Comments

Post a Comment

Popular posts from this blog

South Korea Mandates Fire Extinguishers in All Vehicles with Five or More Seats

-
Image
  Vehicle fire extinguisher Starting December 1, 2024, all vehicles with five or more seats must be equipped with a "vehicle-compatible" fire extinguisher. This regulation follows the amendment to the Fire Facilities Installation and Management Act, which expands the requirement for installing fire extinguishers in vehicles. Applicable Vehicles • Vehicles manufactured, imported, or sold after December 1 • Vehicles newly registered under Article 6 of the Motor Vehicle Management Act due to a change in ownership Note: This regulation does not apply retroactively to vehicles already registered. Verification of Fire Extinguisher Installation in Vehicles Compliance with the fire extinguisher installation requirement will be checked during vehicle inspections conducted under the Motor Vehicle Management Act. Requirements for Vehicle Fire Extinguishers This refers to a fire extinguisher that has not only passed the performance tests for general powder fire extinguishers but has also...
Read more

KCs Ex Certification | Compatibility with IECEx and ATEX

-
Image
  KCs Ex Certification for explosion proof products KCs Ex Certification and Its Compatibility with IECEx and ATEX The IECEx and ATEX international explosion-proof certification systems are globally recognized, and KCs Ex certification is also mutually compatible with these international certifications. Thanks to this compatibility, global companies can easily certify and sell the same product in multiple countries. However, even if a product has already obtained IECEx or ATEX certification, it must still acquire KCs Ex certification to be sold or installed in Korea. During the KCs Ex certification process, some testing and documentation requirements may be waived or simplified. Challenges and Solutions for Obtaining KCs Ex Certification The process of obtaining KCs Ex certification in Korea can be challenging due to complex procedures and extensive documentation requirements. However, with GCA KOREA, you can avoid these complexities and proceed with the certification process quic...
Read more

KCs Ex Certification | Essential Explosion-Proof Safety for Industries

-
Image
  KCs Ex Certification for explosion proof products What is KCs Ex Certification? Essential Safety for Explosion-Proof Products KCs Ex Certification is a Korean explosion-proof safety certification system that ensures electrical machines and devices used in industrial environments with explosion hazards meet strict safety standards. This certification is crucial for the safe use of products in explosive environments and helps protect the safety of workers. Why is KCs Ex Explosion-Proof Certification Necessary? 1. Ensuring Safety In environments with explosive gases, dust, or other hazardous substances, even a small spark can lead to an explosion. KCs Ex Certification minimizes these risks by ensuring products are designed to prevent accidents, thus safeguarding workers' safety. 2. Legal Requirement Under the Korean Industrial Safety and Health Act, electrical machines and equipment with explosion-proof structures must obtain KCs Ex Certification. This is a mandatory requirement to...
Read more