In January 2022, a leading U.K.-based pharmaceutical company approached us for legal assistance in expanding its research and development (R&D) operations to China. The client planned to conduct clinical trials for a new oncology drug and wanted to secure patents to protect its intellectual property (IP). Given the stringent regulations surrounding pharmaceuticals in China, the client required support to ensure compliance with local laws, obtain regulatory approvals, and safeguard its IP rights.

The client faced several regulatory and legal challenges in conducting clinical trials and securing patents in China:

Regulatory Approvals for Clinical Trials: Navigating China’s strict regulatory environment to obtain the necessary approvals from the China National Medical Products Administration (NMPA) for conducting clinical trials.

Intellectual Property Protection: Securing patent protection for the client’s pharmaceutical innovations, particularly in China’s competitive market, which is known for IP challenges.

Compliance with Local Laws: Ensuring the clinical trials adhered to Chinese laws related to patient safety, data protection, and ethical standards.

Technology Transfer and Data Localization: Managing cross-border technology transfers between the U.K. and China, ensuring compliance with Chinese regulations on data localization and export of sensitive information.

Product Registration and Market Entry: Once clinical trials were completed, securing product approval for distribution in China’s pharmaceutical market, which is highly regulated.

Our team began by working with the client to gather all the necessary documentation for the Investigational New Drug (IND) application, which had to be submitted to the China National Medical Products Administration (NMPA). This included preclinical data, protocols for the clinical trials, and patient safety measures. In February 2022, we submitted the IND application to the NMPA. Given the high stakes involved in oncology drug trials, we worked closely with the NMPA’s Center for Drug Evaluation (CDE) to expedite the review process. By April 2022, the NMPA granted approval for the clinical trials to proceed, subject to compliance with specific patient safety and data reporting requirements. Our team provided ongoing support throughout the trial process, ensuring the client adhered to these requirements.

To protect the client’s innovative drug, we began the patent filing process in March 2022. This involved preparing detailed patent applications for submission to the China National Intellectual Property Administration (CNIPA). We ensured that the patent application covered not only the composition of the drug but also the specific processes involved in its manufacture, providing comprehensive protection against potential competitors. By June 2022, we secured the necessary patent approvals for the drug’s formula and manufacturing process, safeguarding the client’s IP and preventing unauthorized production in China.

In April 2022, we established a compliance framework for the client’s clinical trials to ensure adherence to China’s Good Clinical Practice (GCP) guidelines, which regulate the ethical and scientific quality of clinical trials. This framework included patient consent forms, trial protocols, and data protection measures. Given the sensitive nature of patient data, we helped the client implement a data protection protocol that complied with China’s Personal Information Protection Law (PIPL). This ensured that patient data was securely stored and processed, preventing unauthorized access or misuse.

As the client’s clinical trials required the transfer of research data and proprietary technology between the U.K. and China, we assisted in developing a technology transfer agreement in May 2022. This agreement outlined the terms for cross-border data sharing while ensuring compliance with China’s Data Security Law and Cybersecurity Law. We helped the client establish data localization protocols, ensuring that sensitive data from the clinical trials was stored within China’s borders while allowing secure and compliant data transfers to the U.K. for further analysis.

As the clinical trials progressed, we began preparing for the final stage of product registration with the NMPA. In September 2022, we initiated the registration process to obtain approval for the drug’s commercial distribution in China. We provided guidance on post-marketing surveillance requirements, ensuring that the client had the necessary processes in place to monitor the drug’s safety and efficacy once it entered the Chinese market. By December 2022, we successfully obtained market authorization for the client’s oncology drug, allowing the client to begin distributing the product in China.

Regulatory Approvals for Clinical Trials: The client successfully obtained NMPA approval to conduct clinical trials for their oncology drug in China by April 2022. The trials were conducted in full compliance with local regulations, and patient safety protocols were rigorously followed.

Patent Protection Secured: By June 2022, the client secured patent protection for their drug formula and manufacturing process in China, ensuring comprehensive IP protection and preventing competitors from replicating their innovation.

Data Compliance and Technology Transfer: The client’s clinical trials and technology transfer operations complied fully with China’s data protection and localization laws, allowing them to transfer data securely between China and the U.K. Successful Product Registration: By December 2022, the client obtained regulatory approval to market and distribute their oncology drug in China, marking a significant milestone in their global expansion strategy.

Market Expansion into China: The client’s successful entry into China’s pharmaceutical market allowed them to tap into a large and growing demand for innovative cancer treatments, positioning them as a leading provider of oncology solutions in the region.