Actualités réglementaires
20 sept. 2026•1 min de lecture
KPA and MFDS to Hold Parametric Release Training for Sterile Product Manufacturers on Sep 29
The Korea Pharmaceutical Bio Association and the Ministry of Food and Drug Safety will host a technical training on parametric release for final sterilized product manufacturers on September 29 in Cheongju.
Actualités réglementaires
17 sept. 2026•1 min de lecture
MFDS reports 7 GMP observations for Kyungbang Shinyak, all classified as "Other"
The Ministry of Food and Drug Safety disclosed that Kyungbang Shinyak received seven GMP observations in facility equipment and manufacturing, all categorized as "Other" with no major issues.
Actualités réglementaires
14 sept. 2026•1 min de lecture
Korea United Pharm’s Sejong Plant Retains GMP Certification after Ukrainian Inspection
Korea United Pharm announced that its Sejong‑1 plant passed a re‑inspection by Ukraine’s drug regulator, maintaining its GMP certification.
Actualités réglementaires
11 sept. 2026•1 min de lecture
MFDS Revises Pharmaceutical Pre‑GMP Evaluation Manual, Adds New‑Drug and Singapore GMP Provisions
South Korea's MFDS updates its pre‑GMP evaluation handbook after 5 years, introducing dedicated teams for new drugs and incorporating the Korea‑Singapore GMP mutual‑recognition agreement.
Actualités réglementaires
30 août 2026•1 min de lecture
경방신약, 기준서 미준수로 의약품 제조 1개월 정지
경방신약이 제조관리기준서 등 지시서 미준수로 식품의약품안전처로부터 7월 한 달간 두 품목 제조 정지 처분을 받았다.
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Actualités réglementaires
25 août 2026•1 min de lecture
FDA Recalls Drug Over Adulterated API and Content Uniformity Failure
The FDA has recalled a product after discovering an adulterated active ingredient and insufficient manufacturing controls that caused content uniformity failures.
Actualités réglementaires
24 août 2026•1 min de lecture
FDA Identifies GMP Violations Affecting Sterility Assurance
An FDA inspection uncovered GMP violations that may compromise product sterility and quality, prompting a recall.
Actualités réglementaires
24 août 2026•1 min de lecture
PMDA Asia Office GMP Workshop Training 2026 Report Published
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted the report for its 2026 Asia Office GMP Workshop Training.
Actualités réglementaires
23 août 2026•1 min de lecture
FDA Recalls Product Over Sterility Concerns Due to GMP Violations
The FDA has initiated a recall after an inspection revealed GMP violations that could compromise product sterility.
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Actualités réglementaires
23 août 2026•1 min de lecture
Orbit Pharma Recalls Cyclizine Lactate Injection Batch Over GMP Deficiencies
Orbit Pharma Limited is recalling a batch of Cyclizine Lactate 50 mg/ml injection solution due to GMP deficiencies at the manufacturing site.
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