Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
Actualizaciones regulatorias
23 sept 2026•1 min de lectura
FDA Approves ANDA087315 for Hydrocortisone 1% Topical Lotion
The FDA has approved ANDA087315 submitted by Alpharma US Pharms for a 1% hydrocortisone topical lotion, currently listed as discontinued.
Actualizaciones regulatorias
23 sept 2026•1 min de lectura
FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA 086822)
The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor SoloPak as discontinued under ANDA 086822.
Actualizaciones regulatorias
23 sept 2026•1 min de lectura
MHRA Field Safety Notices Issued 14‑18 September 2026
MHRA published a series of field safety notices between 14‑18 Sep 2026 covering cardiac occluders, circulatory assist catheters, orthopedic instruments, endoscopic needles, imaging systems and diagnostic software.
Actualizaciones regulatorias
23 sept 2026•1 min de lectura
Seongdong-gu Pharmaceutical Association Commits to Oppose Expansion of Drug Delivery and Convenience Store Sales
The Seongdong-gu Pharmaceutical Association resolved to actively oppose the expansion of drug delivery services and convenience‑store drug sales, sharing recent pharmacy complaint cases.
Actualizaciones regulatorias
23 sept 2026•1 min de lectura
ALF Bio Secures ISO 45001 Certification to Boost Safety and Quality in Medical Aesthetic Manufacturing
ALF Bio has received ISO 45001 occupational health and safety certification, reinforcing its manufacturing and quality competitiveness in the medical aesthetic sector.
Actualizaciones regulatorias
23 sept 2026•1 min de lectura
KPA Calls for Clear Licensing Rules for Pharmacists and Herbal Pharmacists in 358‑Day Relay Protest
The Korean Pharmaceutical Association held a relay protest at the Blue House, urging the government to clarify licensing scopes and set standards for herbal pharmacists' OTC sales and pharmacist employment.
Actualizaciones regulatorias
23 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
23 sept 2026•1 min de lectura
SK Biopharm Maintains Development of Epilepsy Candidate BHV‑7000 Amid FDA Partial Hold
SK Biopharm keeps its epilepsy drug BHV‑7000 development despite an FDA partial clinical hold, while negotiating a final deal with Biohaven.
Actualizaciones regulatorias
23 sept 2026•1 min de lectura
Korean Health & Welfare Committee Tensions Over MFDS Role Amid Minister Nominee Scrutiny
The first regular Health and Welfare Committee meeting showed sharp partisan clashes, focusing on the MFDS’s responsibility linked to the Justice Minister nominee.
Actualizaciones regulatorias
23 sept 2026•1 min de lectura
KPA hosts Korea‑Vietnam pharma cooperation meeting with DAV delegation
The Korean Pharmaceutical & Bio Association held a Korea‑Vietnam pharma industry cooperation meeting on Oct 10, inviting Vietnam’s Drug Administration and company delegation to discuss regulatory collaboration and reference‑country designation.
Actualizaciones regulatorias
22 sept 2026•1 min de lectura
FDA Discontinues Chlordiazepoxide Hydrochloride ANDA084700
The FDA has listed the ANDA084700 application for Chlordiazepoxide Hydrochloride 10 mg oral capsules as discontinued. Sponsor Roxane filed the original ANDA in 1976.
Actualizaciones regulatorias
22 sept 2026•1 min de lectura
FDA Approves Multiple Supplemental Applications for Discontinued Chlorothiazide Tablets (ANDA 084217)
The FDA record for ANDA 084217 lists two discontinued oral chlorothiazide tablets (500 mg and 250 mg) and a series of approved supplemental submissions covering manufacturing, labeling and bioequivalence.