Expert comment: China’s strategic shift toward global biopharmaceutical innovation

Chinese pharmaceutical and biotech companies are increasingly seeking to expand beyond domestic borders, with particular interest in entering European (EU/EEA) markets – an ambition further accelerated by U.S. tariff policies. Over the past two decades, China has rapidly evolved into a global leader in biopharmaceutical innovation, propelled by significant investments in research, strong advancements in artificial intelligence, and a growing focus on innovative drug development.

Notably, this strategic shift within the Chinese pharmaceutical and biotech sector is strongly supported by the Chinese government. This is reflected in the significant reform of China’s regulatory framework, which has been progressively harmonised with U.S. and EU requirements in several areas, and further alignment efforts continue.

Both China’s 14^th (2021-2025) and 15^th (2026-2030) Five-Year Plans emphasise and encourage continued investment in innovative drug research, artificial intelligence, and international collaboration to strengthen China’s global footprint. This strategic direction marks a shift from China’s traditional dominance in generic-drug manufacturing toward the development and production of high-value, innovative medicines, particularly in therapeutic areas such as oncology and autoimmune diseases. Recent data shows an impressive trend – 31% of the innovative pipeline assets licensed by major global pharmaceutical companies were sourced from China.

Key regulatory barriers to EU/EEA market entry

To establish themselves in the EU-EEA market, Chinese pharmaceutical and biotech companies must navigate several challenges, including regulatory differences, language barriers, and cultural differences. In 2017, China became a full member of ICH, a significant step toward aligning Chinese drug development practices with Western regulatory standards.

However, regulatory alignment is still in the process of evolving. In the area of clinical trials, Chinese companies must adapt to the EU’s centralized Clinical Trials Information System (CTIS), which imposes strict requirements for data transparency, rigorous ethical reviews, and detailed documentation – standards that often differ from those of the National Medical Product Administration (NMPA). Furthermore, differences in patient populations, standard-of-care practices, and data interpretation between China and the EU can complicate the conduct of bridging studies, potentially challenging the market authorisation application process. In many cases, Chinese companies must also expand clinical development into the EU-EEA to meet expectations from European regulators. This requires full compliance with the EU Clinical Trials Regulation (EU CTR 536/2014), which differs substantially from Chinese clinical trial regulations.

Another important aspect to consider is compliance with the GMP requirements. The Chinese GMP (2010/2011 revisions), although directly aligned with WHO standards, shares many principles with EU GMP Part I, yet notable differences remain – particularly in the areas of quality management, the pharmaceutical quality system, qualification processes, and risk management. These gaps must be addressed before the EU-EEA Health Authorities can accept a drug manufactured in China.

On 4 November^, the NMPA released an updated and revised version of GMP requirements for medical devices (2025/ 2026 revisions). The new regulation will take effect on 1 November 2026. In total, 15 chapters and 132 articles have been revised, and three new chapters – covering quality assurance, validation and verification, and contract manufacturing and outsourcing – have been added. These updates strengthen the alignment of China’s medical device GMP framework with the EU Medical Device Regulation (MDR 2017/745) and ISO 13485.

Critical success factors for Chinese pharma in the EU/EEA

In summary, Chinese pharmaceutical and biotech companies must overcome several key hurdles to successfully establish themselves in the EU-EEA, including:

• Understanding and complying with the EU Clinical Trials Regulation (EU CTR)
• Recognising the differences between China’s IND system and Europe’s CTA framework
• Preparing EU-compliant IMPD and CTA dossiers
• Ensuring full compliance with the EU General Data Protection Regulation (GDPR)
• Meeting EU-GMP and MDR requirements
• Establishing pharmacovigilance and safety reporting capabilities within the EU-EEA
• Navigating country-specific regulatory and procedural differences