Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#drug approval ×
Actualizaciones regulatorias
21 sept 2026•1 min de lectura
MFDS eases safety data burden for medical gases and expands orphan‑drug ingredient specs
MFDS announced partial amendments to drug approval regulations, reducing documentation for medical high‑pressure gases and widening multiple‑specification allowances for orphan‑drug active ingredients.
Actualizaciones regulatorias
20 sept 2026•1 min de lectura
South Korea Approves 44th Domestic New Drug, Latica Eye Drops 5%
MFDS approves Latica Eye Drops 5% for adult dry‑eye patients, marking Korea’s 44th domestically developed new drug and expanding treatment options.
Actualizaciones regulatorias
19 sept 2026•1 min de lectura
FDA Approves Manufacturing and Labeling Submissions for Discontinued Chlorpromazine Tablets
FDA has approved multiple manufacturing and labeling submissions for discontinued chlorpromazine hydrochloride tablets, noting the discontinuations were not due to safety or effectiveness concerns.
Actualizaciones regulatorias
19 sept 2026•1 min de lectura
FDA Approves Labeling for PLASMA‑LYTE 56 and Dextrose 5% Injection (NDA 017385)
The FDA approved labeling for the discontinued injectable PLASMA‑LYTE 56 and Dextrose 5% product, with multiple manufacturing submissions approved since 1986.
Actualizaciones regulatorias
19 sept 2026•1 min de lectura
FDA Approves Dextrose 10% & Sodium Chloride 0.9% Injectable (Now Discontinued)
The FDA record NDA018047 shows approval of an injectable solution containing 10% dextrose and 0.9% sodium chloride, now listed as discontinued.
Actualizaciones regulatorias
19 sept 2026•1 min de lectura
FDA Approves Manufacturing Submissions for Discontinued Trimpex Trimethoprim Tablets
The FDA’s NDA 017952 record lists two discontinued oral Trimpex tablets (100 mg and 200 mg trimethoprim) and documents a series of approved manufacturing and labeling submissions spanning 1980‑1997.
Actualizaciones regulatorias
16 sept 2026•1 min de lectura
Experts Call for New Evaluation System for Innovative Cancer Drugs in Korea
At a forum on sustainable healthcare, Professor Ahn Hee‑kyung highlighted bottlenecks in Korean patients’ access to innovative anticancer drugs and urged a valuation framework that includes clinical and socioeconomic benefits.
Actualizaciones regulatorias
16 sept 2026•1 min de lectura
FDA Records Show Discontinued BENEMID (Probenecid) Tablet with Multiple Priority Submissions
The FDA database lists BENEMID, an oral 500 mg probenecid tablet, as discontinued but not for safety or effectiveness reasons, and documents numerous priority supplemental submissions spanning 1976‑1994.
Actualizaciones regulatorias
15 sept 2026•1 min de lectura
FDA Approves ANDA077510 for Colestipol Hydrochloride Tablets
The FDA has approved ANDA077510 for Colestipol Hydrochloride 1 g tablets, manufactured by Amneal Pharmaceuticals and sponsored by IMPAX Labs.
Actualizaciones regulatorias
14 sept 2026•1 min de lectura
South Korea's MFDS Joins ICMRA Executive Committee, First Time Representation
The MFDS has been elected to the ICMRA Executive Committee for 2026‑2029, marking its first seat on the global drug‑regulation decision body.
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Actualizaciones regulatorias
13 sept 2026•1 min de lectura
MFDS launches new review system to cut new drug approval time to 240 days
South Korea's MFDS will activate a parallel-review process within a month, assigning multiple reviewers per area to reduce new drug approval timelines to 240 days.
Actualizaciones regulatorias
11 sept 2026•1 min de lectura
FDA Approves Multiple Clozapine Submissions; All Listed Tablet Products Discontinued
FDA records show four discontinued oral tablet strengths of Clozapine and several approved REMS and labeling submissions spanning 2015‑2025.