drug regulator

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Temas relacionadosnarcolepsy rare disease drug approval china pharmaceuticals medical therapy orphan drug nmpa

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China Approves Commercial Sale of Rare-Disease Narcolepsy Therapy

China's NMPA has approved a rare-disease therapy for commercial sales to treat narcolepsy type 1 in individuals aged 16 and older. The unnamed drug previously received fast-track status in the US and orphan-drug designation in Japan and the EU, indicating international recognition for its importance.

SCMP Economy

1 min de lectura

India's Drug Regulator Flags 159 Samples as Not of Standard Quality in May

En desarrollo

Salud·22/6/2026Resumen IA

India's Drug Regulator Flags 159 Samples as Not of Standard Quality in May

India's Central Drugs Standard Control Organisation (CDSCO) identified 159 drug samples as not of standard quality (NSQ) in May, with 113 flagged by state labs and 46 by central labs. One spurious drug sample was also found in Assam. CDSCO noted these findings apply only to specific batches.

India's Drug Regulator Creates New Rules for Dangerous Solvents in Children's Medicines

India's drug regulator is developing guidelines to restrict high-risk solvents like Propylene Glycol in pediatric medicines after toxic impurities (DEG, EG) in cough syrups caused child deaths.

Economic Times

2 min de lectura