Serialization is not one-size-fits-all. With varying mandates across the U.S., EU, Asia, and the Middle East, companies must navigate a complex web of requirements. Are you prepared for global compliance?
Navigating the Regulatory Landscape: Central Hub for Asia Pacific's Regulations and Related Links
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India
India's pharmaceutical industry is governed by various regulatory bodies, and compliance with traceability standards is crucial to ensuring the safety and integrity of medicinal products.
In the vibrant landscape of China's pharmaceutical industry, adherence to traceability requirements is not just a regulatory mandate; it's a commitment to the highest standards of safety and authenticity. Governed by China's Food and Drug Administration (CFDA), the China Work Plan for Pharmaceutical Electronic Monitioring and 2019 Drug Administration Law pharmaceutical traceability requirements have been meticulously designed to ensure the integrity of medicinal products across the supply chain.
In the dynamic realm of South Korea's pharmaceutical industry, compliance with traceability requirements is a cornerstone of responsible and secure pharmaceutical practices. The Ministry of Food and Drug Safety (MFDS) in South Korea has established stringent regulations to ensure the safety, authenticity, and traceability of medicinal products within the supply chain centered on the Korea Pharmaceutical Information Service system.
Australia's Therapeutic Goods Administration (TGA) serves as the cornerstone of pharmaceutical regulation in the country, operating under the Department of Health and Aged Care. Through rigorous enforcement of the Therapeutic Goods Act 1989 and related regulations, the TGA ensures all therapeutic goods in the Australian market meet exacting standards of safety, quality, and efficacy, thereby safeguarding public health and fostering consumer confidence.
31555 W 14 Mile Rd, Suite 110, Farmington Hills, MI 48334
India Office
SVS One, Street No-2, Patrika Nagar, HITEC City, Hyderabad, Telangana 500081
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