2026年，东盟药品监管正在经历一场“硬约束”升级。越南Circular 32/2026重构了数据保护与申报逻辑，泰国FDA续展新规将7年证书变为实质性重审，菲律宾全面转向ACTD/ACTR体系，印尼BPOM叠加清真强制与本地MAH要求，马来西亚则以PIC/S等同认定让GMP证书成为第一道淘汰线。 对于中国包衣机出口企业来说，这些政策变化意味着一个现实问题：设备能不能卖出去，不再只是价格和性能的事 ...
SHANGHAI, Aug. 4, 2026 /PRNewswire/ -- Innogen Pharmaceuticals (HK.2591), a biopharmaceutical company dedicated to innovative drug discovery and industrialization in metabolic diseases, today ...
Revisions to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide addressing the manufacturing of advanced therapy medicinal products (ATMPs) as well as biological medicinal substances ...
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