News About: Goverment
53 Active Substance Categories Subject to On-Site Inspections Prior to DMF Approval
Reflective of the government's effort to officially implement the Pharmaceutical Bulk Report System scheduled by September of this year, the Korea Food and Drug Administration (KFDA) said it has selected 107 manufactu...
Government to Make Advance Notifications Prior to Conducting Healthcare Service Inspections
The Ministry of Health and Welfare (MOHW) announced on April 12th that it has made a decision to implement a provision of advance notifications prior to conducting inspections on the healthcare service providers, in o...
Joint Task Force to Make Collaborative Efforts on International Trade Activities
The Ministry of Health and Welfare (MOHW) said on April 12th that the efforts between the government and the industry representatives would be performed via forming a joint task force, with an aim to generate effectiv...
Regional KFDA Agency Conducts KGSP Reviews
The Gwangju Regional KFDA (Korea Food and Drug Administration) agency said it is currently undertaking post supervisory reviews on the current practice levels by the pharmaceutical wholesale distributors with KGSP (Ko...
Government to Provide Funding Support for Novel Biopharmaceuticals
The Ministry of Commerce, Industry and Energy (MOCIE) has recently launched an initiative under the name of BioStar Project, a government sponsored funding in support of the identification, research and development of...
KFDA Approves Extended Pediatric Application of LactiCare-HC
Stiefel Korea recently announced that the Korea Food and Drug Administration (KFDA) has given an approval on the extended pediatric application of LactiCare-HC (active ingredient: hydrocortisone) Lotion for the treatm...
April Parliamentary Session Begins with Uncertain Outcome for Pharmaceutical Reform Bill
The domestic pharmaceutical industry is giving its close attention to the National Assembly spring session, which has officially started from April 6th, on the proposed Korea Pharmaceutical Affairs Law (KPAL) reform b...
KFDA to Announce Detailed Outline for Small-Unit Packaging Requirement
It is expected that the detailed outline for the proposed small-unit packaging requirement as applicable the pharmaceutical products will be generated after a completion of contract-based work efforts requested by the...
Active GMP Accreditation Requests by Domestic Nutraceutical Companies
The active level of applications submitted by the domestic nutraceutical companies for attaining a GMP (Good Manufacturing Practice) accreditation is paving a pathway towards the safe and high-quality production of nu...
KFDA Officially Launches Nationwide KGMP Review
The Korea Food and Drug Administration (KFDA) has initiated the nationwide review on the KGMP (Korea Good Manufacturing Practice) certified pharmaceutical facilities and their current operational practices this week, ...
