Get ready for more frequent and rigorous Chinese inspections at your manufacturing facility in Warsaw, Indiana, Memphis, Tennessee, or wherever orthopedic devices are made for distribution in China.
The Chinese government has been inspecting overseas drug companies since 2011 and device companies since 2015. Now, in the middle of a tariff fight, the government is shifting its regulatory philosophy from “stringent” pre-approval supervision to “rigorous” post-approval enforcement and is signaling “increased scrutiny” of foreign drug and device companies.
That’s the warning from Ropes & Gray Attorney Katherine Wang.
New Chinese Inspection Regulations
Wang, based in Shanghai, wrote on January 18, 2019, that the National Medical Products Administration (NMPA) just released the Regulations for Drug and Device Overseas Inspection (regulations). The regulations set out a working procedure for the Chinese government to use at foreign facilities to verify whether foreign drug and device companies’ research and development (R&D) and manufacturing activities adhere to Chinese statutory requirements and standards.
“In recent years,” wrote Wang, “the NMPA began to regulate the entire life cycle of imported drug and device products.” As of December 2018, it had inspected 131 drug products produced in 25 countries. So far, it has inspected 90 device products produced in 13 countries. “Experiences derived from past inspections enabled the NMPA to formalize a set of working procedures in the regulations.”
The regulations, she says, echo the NMPA’s risk-based regulatory approach. The selection of companies inspected largely depends on the company product’s overall risk level. “The NMPA generally considers red flags such as concerns expressed by the Chinese Center for Drug Evaluation (CDE) or Center for Medical Device Evaluation (CMDE) or foreign regulators, past violations, adverse events and quality complaints. The NMPA may also conduct random checks on foreign manufacturers.”
Inspection Scope
According to Wang, the government’s inspections look to verify authenticity, reliability and compliance of R&D and manufacturing activities. “The NMPA usually focuses on (i) consistency of actual manufacturing process with the processes registered with the NMPA, and (ii) China GMP compliance.”
During on-site inspections, she notes that foreign manufacturers must give the government full access to all relevant premises and documents, including real-time manufacturing processes of the product in question. She adds that the government may also extend its inspections to R&D partners and third-party vendors, such as suppliers of active pharmaceutical ingredients (API), excipients or packaging materials. “Foreign manufacturers should coordinate with their partners and vendors to enable these extended inspections. Any foreign manufacturers that do not cooperate with the inspection team will receive a failure notice from the NMPA.”
