From clinical trials to NMPA approval, NRDL pricing to commercial operations — we help global pharma and MedTech companies navigate every regulatory, compliance, and transactional challenge in China.
China is the world's second-largest pharmaceutical market and the fastest-growing major healthcare economy. For global pharma and MedTech companies, China is no longer optional — but the regulatory complexity demands expert local counsel.
A pharma or MedTech product's journey in China involves distinct legal and regulatory challenges at every stage. We provide end-to-end counsel across the entire lifecycle.
End-to-end HGR strategy for international clinical trials. We handle cooperation filings with MOST, information backup/security review for cross-border data transfer, and the complex "foreign party" designation rules under the 2023 Implementing Rules.
Strategic counsel on product classification, registration pathways (Category 5.1 import drugs, Class II/III devices), accelerated review designations, and patent linkage under the 2021 framework. We work with your regulatory team to de-risk the approval timeline.
China's PIPL imposes heightened obligations on "sensitive personal information" including health data. We design compliant architectures for: clinical data localization, pharmacovigilance reporting to global headquarters, HCP/patient CRM systems, and cross-border transfer via China SCCs or security assessment.
Build compliance systems that satisfy both FCPA and China's Criminal Law Article 164. We cover: HCP speaker program protocols, academic sponsorship guardrails, distributor due diligence, patient assistance program (PAP) structuring, and internal investigation response.
Navigate China's national reimbursement listing (NRDL) negotiations and volume-based procurement (VBP) tenders. We advise on global pricing strategy implications, tender contract obligations, and dispute resolution when supply commitments are challenged.
Full-service support for license-in/license-out transactions, asset acquisitions, and JV structuring in the pharma space. Core expertise: technology import/export registration, IP due diligence, MAH transfer procedures, and antitrust (merger control) filings.
Protect your pharmaceutical IP portfolio in China. We handle patent linkage litigation, invalidation challenges, trade secret protection for manufacturing processes, and anti-counterfeiting enforcement through administrative and judicial channels.
Legal support for CMO/CDMO contracting, GMP compliance investigations, product liability defense, supply chain ESG audits, and recall crisis management. We bridge the gap between quality/regulatory and legal risk.
These are the compliance domains that keep General Counsel and Compliance Officers of global pharma companies awake at night. We provide proactive risk management, not just reactive firefighting.
Unauthorized export of Chinese genetic samples or associated data can trigger administrative penalties, suspension of clinical activities, and criminal liability under the amended HGR Regulations (2023). We audit existing trial portfolios for HGR gaps and design compliant architectures from protocol inception.
China's healthcare anti-corruption campaign has intensified, with multi-agency task forces targeting pharmaceutical companies. Combined with FCPA exposure for US-linked entities, the dual enforcement risk is severe. We build compliance programs that withstand scrutiny from both Chinese and foreign regulators.
Clinical data, PV safety data, and HCP information increasingly require security assessments or standard contracts before leaving China. The tension between global pharmacovigilance obligations and Chinese data localization requirements requires careful legal architecture.
Under China's evolving anti-bribery doctrine, pharmaceutical companies face vicarious liability for the actions of their distributors, CSOs, and service providers. Pre-engagement due diligence, contractual protections, audit rights, and ongoing monitoring are essential.
Employee mobility between pharma companies, CROs, and CDMOs creates significant trade secret risk. We help implement technical and legal safeguards, including post-employment restrictions and rapid-response litigation when breaches occur. The 2020 amendment to the Anti-Unfair Competition Law significantly increased damages for trade secret misappropriation.
Global ESG disclosure requirements increasingly extend to Chinese pharmaceutical supply chains. We assist foreign pharma companies in auditing supplier compliance with environmental, labor, and anti-forced-labor standards, and managing the legal implications of adverse findings.
Luo Wei is a Partner at Jiangsu Tianni Law Firm with 17 years of legal practice, specializing in international dispute resolution, cross-border investment, and corporate governance. His clients span the United States, the UK, Germany, France, Switzerland, Singapore, UAE, Japan, South Korea, and Australia — including several multinational pharmaceutical and medical device companies.
Drawing on deep experience in both international arbitration (CIETAC, UNCITRAL, LCIA) and Chinese regulatory proceedings, Luo Wei offers foreign pharma and MedTech clients a unique combination: the cultural and legal fluency to translate between global headquarters and Chinese regulators, and the litigation bench strength to defend your interests when disputes arise.
As a member of the Jiangsu Provincial Bar Association International Commercial Arbitration Committee, the Nanjing Bar Association Corporate Governance Committee, and the Young International Arbitration Group (YIAG) of the LCIA, Luo Wei stays at the forefront of both regulatory developments and dispute resolution practice. He was recognized as an Outstanding Foreign-Related Lawyer (2019–2022).
Analysis of updated cross-border data transfer regulations and what they mean for global clinical trial sponsors.
The Supreme People's Court clarifies data export obligations. What pharma companies need to know.
Updated analysis of foreign investment restrictions and opportunities in pharma, biotech, and medical services.
How European ESG legislation is reshaping compliance requirements for pharmaceutical supply chains in China.
Announcing a strategic partnership with SIWOO Law Firm (Seoul) to create a green channel for Sino-Korean pharma legal services.
Practical insights on the 2024 PRC Company Law amendments and their impact on WFOE and JV board structures.
Whether you are preparing for an NMPA submission, structuring a China-facing clinical trial, negotiating a license deal, or responding to a regulatory investigation — we bring 17 years of cross-border legal experience to your matter.
We work in English and Chinese, on your time zone. Initial consultations are confidential and without obligation.
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