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Showing posts from August, 2025

Roadmap to Drug Approval Process in Chinese Market

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  Due to the increasing demand for high-quality healthcare, China has emerged as a major market for pharmaceutical products and is now one of the world’s leading manufacturers of  pharmaceuticals . The market is ambitious and places emphasis on innovation and domestic research and development. By 2024, the Chinese pharmaceutical market exceeded USD 80 billion in revenue, making it the second largest in the world after the United States. The pharmaceutical manufacturing segment alone is projected to reach USD 183 billion by 2025. To get approval for any new medication to be launched into the Chinese market, one must understand the complexities of the drug approval process. What Types of Drugs Are Approved in the Chinese Market? Innovative Medications : Includes  biopharmaceuticals , gene and cell therapies, as well as rare disease treatments. These treatments are created using the latest findings in immunology, genetics, and biotechnology. Generic Drugs : Since there is a ...

Medical Device Approval in India with Regulatory Expertise

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India’s medical device market is one of the fastest growing in the world, According to Invest India, India’s medical device market valued at around USD 11 billion in 2022–23, is projected to reach USD 50 billion by 2030, growing at a CAGR of approximately 16.4% [ Report ]. As global manufacturers and startups set their sights on this high-potential market,   regulatory compliance   becomes the pivotal differentiator between accelerated market entry and lengthy delays. But navigating India’s regulatory framework overseen by the  Central Drugs Standard Control Organization  (CDSCO) requires more than just documentation. It demands strategic expertise, local intelligence, and proactive lifecycle management. Here’s how partnering with seasoned regulatory experts can fast-track your approvals, mitigate risk, and position your product for long-term success. Understanding the Indian Regulatory Landscape for Medical Devices India regulates medical devices under the Medical D...