News About: Goverment
KFDA Bans Antipsychotic Drugs Containing Thioridazine Hydrochloride
The Korea Food and Drug Administration (KFDA) recently announced of a decision to ban the antipsychotic drugs containing thioridazine hydrochloride in the domestic market effective July of this year.
The decision i...
Total of 296 New Drug Approvals Granted Year-to-Date
According to the report released by the Korea Food and Drug Administration (KFDA), the number of new drug approvals granted during the current year is 296, of which the approvals on the ethical, or prescription, drugs...
Bioequivalence Testing, Small-Unit Packaging Requirements Become Officially Enacted Next Month
The pharmaceutical industry expects an official enactment of the amendment proposals to the Korea Pharmaceutical Affairs Law (KPAL) towards the end of April, as the proposals recently received the final set of revisio...
Government to Release Guideline for Review of Biopharmaceutical Products
The Korea Food and Drug Administration (KFDA) announced on March 28th that it has released a comprehensive guideline with detailed evaluation procedures as specific to the safety and efficacy profiles of biopharmaceut...
129 Pharmaceutical Products Receive Revised Approval Specifications
The Korea Food and Drug Administration (KFDA) recently announced that a total of 129 pharmaceutical products from 14 ingredient/formulation categories have been issued the revised post-marketing approval specification...
Allergan Korea's Botox Receives Extended Validity Period by KFDA
Allergan Korea announced on March 28th that the Korea Food and Drug Administration (KFDA) approved for an extension of validity period for Botox (botulinum toxin type A) from the existing 2-year period to 3-year perio...
Investigation on Retail Transactions for OTC Medications Announced
The Korea Pharmaceutical Association (KPA) recently announced that it plans to undertake an investigation on the actual retail transactions for the over-the-counter (OTC) medications that are being sold at the nation'...
Government Issues Regulatory Guidelines for Domestic Human Tissue Banks
With the total number of approved human tissue banks reaching at 35 in the nation, the Korea Food and Drug Administration (KFDA) has released the specific regulatory guidelines to be followed by the licensed instituti...
Revised Classification Scheme for Medical Devices Set Forth
The existing classification scheme on the medical devices and equipments as predicated by the Pharmaceutical Affairs Law is now governed by the revised Medical Devices Act, as per an announcement by the Korea Food and...
Total Number of Pharmaceutical Drugs Assigned with Re-Examination at 880 Items
The total number of pharmaceutical drugs that have been identified and assigned the regulatory drug re-examination is determined at 880 items, in which GlaxoSmithKline (GSK) Korea has the most number of products among...
