Article source：Kexing Biopharm
Oct 10,2025
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127 As global healthcare continues to evolve, Europe has emerged as a critical destination for pharmaceutical expansion. For Chinese pharmaceutical companies, the European market represents both an opportunity and a formidable challenge. With its sophisticated healthcare systems, strong intellectual property protections, and stringent regulatory environment, Europe offers a pathway to global credibility — but only for those prepared to meet its demanding standards.
Chinese pharma companies have made remarkable progress over the past decade. Backed by domestic innovation, improved manufacturing capabilities, and a growing emphasis on international quality standards, firms like Kexing Biopharm are now eyeing Europe as part of their globalization strategy. Yet, navigating the European Medicines Agency (EMA) framework and the patchwork of national regulatory bodies remains a steep learning curve.
Unlike some markets where drug registration follows a single national authority, Europe operates a complex, multi-layered system. The European Medicines Agency (EMA) oversees the centralized procedure, which enables a company to obtain a marketing authorization valid across all EU member states and the European Economic Area (EEA). This pathway is mandatory for certain product categories — including biotechnology-derived medicines, orphan drugs, and advanced therapies — and is highly attractive for companies seeking broad access.
Under the centralized procedure, the Committee for Medicinal Products for Human Use (CHMP) evaluates applications. The process requires a comprehensive dossier following the Common Technical Document (CTD) format aligned with International Council for Harmonisation (ICH) standards. This ensures consistency with global regulatory expectations, but it also demands a high level of data integrity, transparency, and traceability — aspects that may require significant investment for companies accustomed to different regulatory environments.
Beyond the EMA, many products still require country-specific approvals through decentralized or mutual recognition procedures. Countries like Germany, France, and Spain have their own health authorities with distinct requirements, timelines, and pricing structures. For example, Germany’s Federal Institute for Drugs and Medical Devices (BfArM) may have particular expectations regarding clinical data interpretation or labeling, while France’s National Agency for Medicines and Health Products Safety (ANSM) can impose additional post-marketing requirements.
Equally critical are pharmacovigilance obligations. Once a product enters the market, the marketing authorization holder must continuously monitor safety data, report adverse events, and maintain a qualified person responsible for pharmacovigilance (QPPV) within the EU. Establishing compliant pharmacovigilance systems often requires partnerships with European service providers and robust internal quality management.
The pathway to European market entry is rarely straightforward. Chinese pharmaceutical companies face several recurring challenges when adapting to European regulatory expectations.
Although China’s National Medical Products Administration (NMPA) has harmonized many of its regulations with ICH guidelines, legacy data and older clinical studies often fall short of EMA expectations. Bridging studies or additional trials may be required to validate pharmacokinetic, safety, and efficacy data. Ensuring the integrity of manufacturing and clinical data is non-negotiable for European regulators.
Clinical trial design remains one of the most significant hurdles. European regulators often demand more diverse patient populations, rigorous randomization, and adherence to Good Clinical Practice (GCP) aligned with EU standards. Additionally, local ethics committee approvals and data protection compliance (GDPR) add another layer of complexity. Many Chinese firms collaborate with EU-based Contract Research Organizations (CROs) to align trial methodologies and documentation.
Even after obtaining approval, companies face the challenge of navigating Europe’s fragmented pricing and reimbursement landscape. Each country negotiates prices independently, often based on health technology assessments (HTAs). Moreover, the protection of intellectual property and data exclusivity timelines differ from those in China. Companies must carefully plan patent filings and market entry strategies to secure competitive positioning and avoid generic competition too early.
Kexing Biopharm, one of the leading multinational biopharmaceutical companies in China, offers a compelling case study in how to strategically approach the European market. Rather than treating compliance as a final step, Kexing Biopharm has made it an integral part of its global strategy.
Kexing Biopharm is ensuring that all facilities meet EU Good Manufacturing Practice (GMP) standards. Regular internal audits and third-party inspections are embedded in its operations. By investing early in quality infrastructure, Kexing Biopharm minimizes the risk of regulatory surprises later in the approval process.
Furthermore, Kexing Biopharm has made substantial investments in quality assurance and GMP audits, not just to pass inspections but to institutionalize continuous improvement. By doing so, it positions itself as a trusted partner capable of delivering consistent, high-quality biologics — a crucial factor for winning acceptance among European healthcare providers and patients.
Entering the European pharmaceutical market is a marathon, not a sprint. The regulatory rigor of the EMA and national authorities demands technical excellence, operational transparency, and strategic foresight. For Chinese pharma companies, success depends on more than scientific innovation; it requires long-term investment in compliance, partnerships, and data integrity.
Europe rewards patience and alignment. Those willing to adapt to its rules can gain not only market access but also global credibility.
Learn how Kexing Biopharm is navigating Europe to bring affordable biologics to patients.
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Sep 08,2023
