Regulatorische Updates
Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit
#pharmaceutical regulation ×
Regulatorische Updates
28. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA083919 for MILTOWN Oral Tablet (Meprobamate 600 mg)
The FDA has approved application ANDA083919 for MILTOWN, an oral tablet containing 600 mg of meprobamate, sponsored by Medpointe Pharm HLC.
Regulatorische Updates
27. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA076721 for Megestrol Acetate Oral Suspension
The FDA approved ANDA076721 for Megestrol Acetate oral suspension (40 mg/mL) submitted by PHARMOBEDIENT and manufactured by Xttrium Laboratories.
Regulatorische Updates
25. Sept. 2026•1 Min. Lesezeit
FDA Approves Manufacturing Supplements for Isoniazid (ANDA080132)
FDA approved three manufacturing supplement submissions for Isoniazid tablets (50 mg and 100 mg) under ANDA080132; both products are listed as discontinued.
Regulatorische Updates
25. Sept. 2026•1 Min. Lesezeit
PMDA-ATC MRCT/GCP Inspection Seminar 2027 Opens Applications for APEC Regulators
The PMDA-ATC workshop in Tokyo (Jan 26‑29, 2027) offers free training on MRCT review and GCP inspection for APEC regulatory officials.
1
Regulatorische Updates
23. Sept. 2026•1 Min. Lesezeit
Health and Welfare Committee Chair Calls for Inquiry into Abortion Medication
Chair Lee Man-hee urges a formal committee inquiry into abortion drugs, citing public concern and government inaction.
Regulatorische Updates
22. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA078039 for Meloxicam Oral Tablets (7.5 mg & 15 mg)
The FDA has granted approval for ANDA078039 submitted by CR DOUBLE CRANE for meloxicam oral tablets in 7.5 mg and 15 mg strengths. Both products are listed as discontinued.
Regulatorische Updates
22. Sept. 2026•1 Min. Lesezeit
Lee Yoon-hak, New Head of Drug Price Negotiations, Prioritizes Essential Medicine Access and Innovation
Lee Yoon-hak, appointed head of drug price negotiations at Korea’s Health Insurance Review & Assessment Service, vows to boost essential medicine access, foster new‑drug development and ensure rational post‑pricing management.
Regulatorische Updates
20. Sept. 2026•1 Min. Lesezeit
First Phase of Drug Price Ceiling Reassessment Targets 14,013 Items, 1,576 Excluded
Korea's Health Insurance Review & Assessment Service released a list of 14,013 drugs for price‑ceiling re‑evaluation, excluding 1,576 items, leaving 12,437 for review.
Regulatorische Updates
20. Sept. 2026•1 Min. Lesezeit
Korea clarifies drug reimbursement classification in health insurance law amendment
The Ministry of Health and Welfare announced that a State Council‑approved amendment to the National Health Insurance Act now clearly defines reimbursable and non‑reimbursable drugs, while preserving protections for severe and rare disease patients.
Regulatorische Updates
19. Sept. 2026•1 Min. Lesezeit
Korea reviews stricter CSO oversight and re-delegation ban in pharma sector
The Pharmaceutical Industry Innovation Public-Private Council is evaluating a ban on re-delegation and tighter reporting for drug promotional sales reps, with three proposals likely to be codified.
Regulatorische Updates
19. Sept. 2026•1 Min. Lesezeit
FDA Approves Labeling Submissions for Loxapine Succinate (ANDA076762)
FDA has approved several labeling supplements for the discontinued oral capsule products of Loxapine Succinate under ANDA076762.
Regulatorische Updates
18. Sept. 2026•1 Min. Lesezeit
MFDS to Add Stevens-Johnson Syndrome to Labels of 56 Oral Aripiprazole Products
South Korea’s MFDS will amend the approval conditions for 56 oral aripiprazole medicines, adding Stevens-Johnson syndrome as a reported adverse reaction. The change involves 12 manufacturers.