Regulatorische Updates

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.

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.

Korea United Pharm announced that its Sejong‑1 plant passed a re‑inspection by Ukraine’s drug regulator, maintaining its GMP certification.

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.

경방신약이 제조관리기준서 등 지시서 미준수로 식품의약품안전처로부터 7월 한 달간 두 품목 제조 정지 처분을 받았다.

The FDA has recalled a product after discovering an adulterated active ingredient and insufficient manufacturing controls that caused content uniformity failures.

An FDA inspection uncovered GMP violations that may compromise product sterility and quality, prompting a recall.

The Pharmaceuticals and Medical Devices Agency (PMDA) has posted the report for its 2026 Asia Office GMP Workshop Training.

The FDA has initiated a recall after an inspection revealed GMP violations that could compromise product sterility.

Orbit Pharma Limited is recalling a batch of Cyclizine Lactate 50 mg/ml injection solution due to GMP deficiencies at the manufacturing site.