{
"@context": "https://schema.org",
"@graph": [
{
"@type": "WebPage",
"@id": "https://www.fortrea.com/insights/providing-regulatory-support-china-new-compound#webpage",
"url": "https://www.fortrea.com/insights/providing-regulatory-support-china-new-compound",
"name": "Providing regulatory support in China for a new compound",
"description": "This Fortrea case study explores how regulatory support in China was implemented to support new compound clinical development and preparation for Phase III clinical trial activities within the NMPA regulatory framework. The study involved a pharmaceutical sponsor requiring NMPA consultation support for new compounds, regulatory submission planning, and guidance on the regulatory pathway for drug development in China. The case study highlights challenges related to local regulatory requirements, communication with health authorities, clinical development planning, and coordination of nmpa clinical trial activities during the development process. Fortrea provided pharmaceutical regulatory consulting and NMPA regulatory support to help align development strategy, regulatory documentation, and operational planning with China-specific clinical and regulatory expectations. By integrating regulatory consulting with local clinical development coordination, the approach supported progression through regulatory review and strengthened operational readiness for clinical trial execution in China"
},
{
"@type": "BreadcrumbList",
"itemListElement": [
{
"@type": "ListItem",
"position": 1,
"name": "Home",
"item": "https://www.fortrea.com"
},
{
"@type": "ListItem",
"position": 2,
"name": "Insights",
"item": "https://www.fortrea.com/insights/"
},
{
"@type": "ListItem",
"position": 3,
"name": "Providing regulatory support in China for a new compound",
"item": "https://www.fortrea.com/insights/providing-regulatory-support-china-new-compound"
}
]
},
{
"@type": "Organization",
"@id": "https://www.fortrea.com/#organization",
"name": "Fortrea",
"url": "https://www.fortrea.com",
"description": "Fortrea is a global contract research organization built on more than 30 years of experience and one of the earliest CRO legacies in the industry—as Covance, evolving within Labcorp, and now operating as Fortrea. With deep expertise across Phase I–IV clinical trials, Fortrea advances clinical research through a patient-centric approach that prioritizes meaningful outcomes, stronger site–CRO relationships, and operational excellence. Fortrea partners with biopharmaceutical, biotech, and medical device companies to advance therapies through every stage of clinical development. This commitment is further reinforced by the launch of Fortrea Intelligent Technology, enabling smarter, more connected, and data-driven clinical development. Through Fortrea Intelligent Technology, the organization is advancing data-driven, technology-enabled clinical development to improve speed, quality, and patient outcomes. It is shaped by experience, innovation, and a commitment to raising standards in clinical research—focused on accelerating development and helping bring life-changing treatments to patients around the world.",
"logo": "https://www.fortrea.com/sites/default/files/2025-05/fortrea-logo-without-background.png",
"sameAs": [
"https://www.linkedin.com/company/fortrea",
"https://www.threads.net/@fortreacro",
"https://twitter.com/fortrea",
"https://www.youtube.com/@Fortrea/",
"https://www.facebook.com/Fortrea-104143099267108",
"https://www.instagram.com/fortreacro"
]
},
{
"@type": "Article",
"@id": "https://www.fortrea.com/insights/providing-regulatory-support-china-new-compound#casestudy",
"mainEntityOfPage": {
"@id": "https://www.fortrea.com/insights/providing-regulatory-support-china-new-compound#webpage"
},
"headline": "China Regulatory Support and NMPA Strategy for New Compound Development",
"description": "This Fortrea case study explores how regulatory support in China was implemented to support new compound clinical development and preparation for Phase III clinical trial activities within the NMPA regulatory framework. The study involved a pharmaceutical sponsor requiring NMPA consultation support for new compounds, regulatory submission planning, and guidance on the regulatory pathway for drug development in China. The case study highlights challenges related to local regulatory requirements, communication with health authorities, clinical development planning, and coordination of nmpa clinical trial activities during the development process. Fortrea provided pharmaceutical regulatory consulting and NMPA regulatory support to help align development strategy, regulatory documentation, and operational planning with China-specific clinical and regulatory expectations. By integrating regulatory consulting with local clinical development coordination, the approach supported progression through regulatory review and strengthened operational readiness for clinical trial execution in China",
"genre": "Case Study",
"author": {
"@type": "Organization",
"name": "Fortrea",
"url": "https://www.fortrea.com/"
},
"publisher": {
"@id": "https://www.fortrea.com/#organization"
},
"datePublished": "2025-02-21",
"dateModified": "2025-02-21",
"encoding": {
"@type": "MediaObject",
"contentUrl": "https://www.fortrea.com/sites/default/files/2025-02/providing-regulatory-support-in-china-for-a-new-compound.pdf",
"encodingFormat": "application/pdf"
}
}
]
}