News About: Goverment
Zelmac Approved for Chronic Idiopathic Constipation by KFDA
Novartis Korea announced on February 28th that the Korea Food and Drug Administration (KFDA) gave approval for a supplemental indication for its pro-motility drug Zelmac (active ingredient: tegaserod) for the treatmen...
New Industry Standards for Bioequivalence Testing on 43 Ingredients
The Korea Food and Drug Administration (KFDA) recently released the standard bioequivalence testing guidance on 43 pharmaceutical active ingredients, including gabapentin, glimepiride, rebamipide, and cefroxidine, amo...
226 Drugs with Reduced National Health Insurance Pricing
The average reduction of National Health Insurance (NHI) medication price is determined at 6.3%, based on the post-marketing insurance price review conducted by the Ministry of Health and Welfare (MOHW) on 749 drugs l...
Phased Rollout of Bioequivalence Testing Requirement Suggested
The Regulatory Reform Committee released on February 25th of its review details and recommendations on various amendment proposals to the Korea Pharmaceutical Affairs Law, covering the major areas such as bioequivalen...
MOHW Prepares Full Assessment on Separation Law
The Ministry of Health and Welfare (MOHW) is reported to announce a detailed roadmap plan during the month of March, under its current initiative of making assessments on the regulation for separation of dispensary fr...
All KGMP Certified Manufacturers Subject to Evaluation
The Korea Food and Drug Administration (KFDA) made an official announcement this week to launch a joint assessment review on 226 KGMP (Korea Good Manufacturing Practice) certified manufacturers of pharmaceutical produ...
Compulsory Bioequivalence Testing Requirement under Further Deliberation
As the industry constituents has essentially reached a general consensus on the enforcement of small-unit packaging requirement for pharmaceutical products in a periodic rollout scheme, the compulsory bioequivalence t...
Favorable Insurance Pricing for Bioequivalent Generics Now Terminated
Effective February 22nd, the generic drugs approved for their bioequivalance are no longer subject to the favorable pricing provision by the government, in which their registrations to the National Health Insurance (N...
Classification of Pharmaceutical and Cosmetic Products to be Revised
The domestic pharmaceutical and cosmetic industries are keenly focusing on a recent announcement made by the Korea Food and Drug Administration (KFDA) of its proposal to make changes to the current classifications of ...
GMP Validation Will Become Mandatory within 2-3 Years
The required focus on the GMP (Good Manufacturing Process) Validation and its regulatory implementation as compulsory are needed to further strengthen quality management in the pharmaceutical, biopharmaceutical and me...
