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

Korea-Czech Industry and Energy Tech Forum Held in Prague

-
Image
  Korea-Czech Industry and Energy Tech Forum Held in Prague The Czech Republic, known for its global leadership in precision machinery, optics, and nanomaterials, is strengthening its technological ties with Korea. To further enhance this cooperation, the Ministry of Trade, Industry, and Energy hosted the Korea-Czech Industry and Energy Tech Forum on September 20 in Prague. Key Participants and Outcomes Over 40 Czech institutions, including the Czech Technical University, and various Korean organizations, such as Hyundai and Sungkyunkwan University, took part in this significant event. A total of 12 Memorandums of Understanding (MOUs) were signed during the forum, aimed at promoting collaboration in robotics, laser technology, hydrogen, and other advanced fields. These agreements pave the way for more concrete technological exchanges between the two nations. Future Plans for Cooperation The forum also focused on plans to develop mid-to-large scale R&D projects in fields like pr...
Read more

Revision of EMC Standards at the Korea RRA

-
Image
Korea RRA EMC Standards Update Revision of EMC Standards at the Korea RRA Some EMC standards are scheduled to be updated in accordance with the revision of the national standard (KS) in the field of electromagnetic compatibility. Public comments will be accepted until November 11, 2024. 📝 KS C 9832:2023 → KS C 9832:2024 Electromagnetic Interference Prevention Test for Multimedia Equipment 🔄 Key Changes: Allowing TV patterns for video port testing. Relaxing the impedance tolerance limit of the voltage probe used in conducted emission tests (148.5 Ω → 131 Ω). 🤝 Contact GCA KOREA today for KC Certification in South Korea.      We provide fast and accurate certification services! 👉 Contact GCA Tel. +82-31-360-8180 Email: forest.lee@gca-kr.com GCA Global Website
Read more