Katherine Wang is a partner in our life sciences group. Widely regarded as a leading life sciences regulatory lawyer in China, Katherine assists pharmaceutical, biotechnology, and medical device companies on a wide range of matters, including early-stage discovery, product registration, regulatory/GxP compliance, pricing, reimbursement, clinical studies, promotional practices, product safety issues, government investigations, and risk assessments. Katherine provides day-to-day counseling on issues that life sciences companies face in relation to their interaction with agencies including the National Medical Products Administration (NMPA, formerly the CFDA), the National Health Commission (NHC) and the State Administration of Market Regulation (SAMR), among others. She also assists institutional investors and corporate clients in structuring transactions and conducting regulatory due diligence, including good laboratory practice (GLP), good clinical practice (GCP), good manufacturing practice (GMP) and pharmacovigilance, on investment targets and prospective business partners in China. Recently Katherine has provided critical guidance to clients on a variety of legal and regulatory issues associated with the COVID-19 pandemic, including advising on regulatory requirements related to PPE export and the development of drugs or vaccines, and helping clients navigate evolving developments in the life sciences industry.
Before entering into private practice, Katherine served as the head of AstraZeneca’s legal department in the Asia-Pacific region. In this role, she advised on critical strategic and operational initiatives to ensure legal compliance and realization of business objectives. She was also responsible for cross-functional intellectual property enforcement and anti-counterfeiting efforts.
Regulatory & Compliance
- Routinely advises foreign life sciences companies on their China entry strategies, particularly issues relating to the selection of regulatory pathways, availability for fast track approvals, regulatory exclusivities, and relationships with local regulatory agents and distributors.
- Routinely represents multinational pharmaceutical and medical device companies in matters relating to their clinical studies in China, particularly concerning Chinese National Human Genetic Resources Administration Office approvals, localization of clinical study agreement templates, clinical trial authorizations, informed consent, waiver for registration studies, non-registration studies, importation of clinical study drugs, contract manufacturing of placebos, study insurance, privacy protection, dealings with CROs, research injuries, and dispute resolution.
- Assisted several multinational pharmaceutical companies in matters relating to the conduct of secondary medical research in China, e.g. collection, use, import and export of human biological samples, construction of biobanks through collaborations with Chinese hospitals, and radioactive labeling of human biological samples in China.
- Advised several multinational pharmaceutical and medical device companies on issues associated with localization of product manufacturing in China, including the establishment of manufacturing facilities, type testing requirements for locally made products, possibilities for clinical trial waivers, and product approval pathways.
- Routinely advises multinational pharmaceutical and medical device companies on promotional practices, particularly off-label promotion, pre-approval communication and direct-to-patient communication.
- Advised several multinational pharmaceutical and medical device companies on market access issues in China, particularly related to pricing, reimbursement, tendering, and patient assistance programs.
- Advised several leading biopharmaceutical companies on biosimilar strategies in China.
- Routinely advises institutional and corporate investors in the conduct of regulatory due diligence on issues ranging from product approvals, compliance with GLP/GCP/GMP, and post-market compliance of their potential investment targets in China.
- Advised several leading U.S.-based health care service providers on the offering of telemedicine in China, particularly the Chinese regulatory framework for telemedicine, the collaboration agreements with local partners, and patient informed consent forms.
- Advised several U.S.-headquartered, privately-owned medical device manufacturers on the establishment of its green-field operation in China; assisted in navigating the regulatory approval terrain for medical device distribution and manufacturing licenses; assisted with registration strategies of made-in-China products.
- Advised one of the top 5 medical device manufacturers in its strategic collaboration with Wuhan Asia Heart Hospital as a part of its global value-based health care initiatives.
- Advised the company on the regulatory requirements for the practice of medicine and the compliance issues related with the supply of medical instruments and equipment under the collaboration.
- Advised several multinational life sciences companies and investment funds on the general regulatory environment concerning OTCs, cosmetics (including medical aesthetics), dietary supplements, and veterinary drugs in China.
Investigation & Risk Assessment
- Assisted several multinational pharmaceutical and medical device companies with the preparation for potential onsite inspections by the Human Genetic Resources Administration of China.
- Assisted several multinational pharmaceutical and medical device companies with their risk assessment projects in China, covering issues related to promotional compliance, conflicts of interest allegations associated with its clinical operations team in China, legitimacy of non-interventional studies or patient registry studies, and fair market value of payments to study sites and investigators.
- Advised several medtech companies on their responses to government inquiries associated with non-conformity to China’s mandatory product standards and remedial actions.
- Advised a leading US-based medical consumable manufacturer on its response to an investigation initiated by China’s National Medical Products Administration on the supply of Research-Use-Only reagents to health care institutions.
- Advised a U.S.-headquartered medical equipment manufacturer on its response to an investigation initiated by local Administration of Market Regulation on potential violations of the Good Sales Practices and product labeling rules.
- Advised a leading U.S. pharmaceutical company on the material transfer agreement with China’s Center of Disease Control to develop anti-COVID-19 therapeutics.
- Advised a U.S.-based vaccine manufacturer on the regulatory requirements for co-development and local manufacture of COVID-19 vaccines.
- Advised a leading U.S. pharmaceutical company on export requirements for its serology test kits to Europe.
- Quoted, “Beauty Market News: China Cosmetics Regulations Modernized,“The Rose Sheet (July 8, 2020)
- Author, “Expanded access to investigational drugs and medical devices in China,” Thomson Reuters Practical Law UK and Practical Law China (June 17, 2020)
- Profiled, “Power & Parity,” Asia Business Law Journal (May 20, 2020)
- Quoted, “Who owns a virus? Covid-19 reignites debate on ‘viral sovereignty’,” South China Morning Post (May 14, 2020)
- Co-author, “China's New Drug Administration Law Frames A Promising Regulatory Landscape,” Asia-Pacific Biotech News (December 9, 2019)
- Co-author, “Building a “Healthy China” Through Innovation and Compliance,” Ropes & Gray (September 20, 2019)
- Quoted, “China Widens MAH Scheme To Medtech As Consumables Face Price Cuts,” Medtech Insight (September 16, 2019)
- Author, “China proposes major changes to pharmaceutical regulations,” Asia-Pacific Biotech News (June 12, 2019)
- Quoted, “No Room For Error: China Proposes Hefty Fines On Quality Violations In Drug Law Overhaul,” Pink Sheet (May 20, 2019)
- Author, “Updates from China’s Life Sciences Industry,” Asia Pacific Biotech News (February 11, 2019)
- Quoted, “Random Checks Now Routine: China To Inspect Your Factories Near And Far,” The Pink Sheet (January 16, 2019)
- Quoted, “Industry Insight: APMTF2018 sound-bites - China reforms and opportunities for market access,” FirstWord MedTech (October 10, 2018)
- Quoted, “Attorneys Urge Chinese Regulator to Engage More With Industry,” International Devices & Diagnostics Monitor (September 7, 2018)
- Co-author, “Public Private Collaboration to Advance Medtech Regulation Reform,” (September 5, 2018)
- Quoted, “China Simplifies Device Registration Requirements,” FDA News (August 31, 2018)
- Author, “China’s New Medical Device Regulations Bring Big Changes,” Law360 (July 23, 2018)
- Profiled, “Ten Pioneers of New Legal Thinking: From Access to Justice to Spin-Off Ventures,” Financial Times (June 7, 2018)
- Co-author, “What Companies Need to Know About China’s New Market Regulator,” Law360 (April 12, 2018)
- Quoted, “Goodbye CFDA, Hello MRA: China Overhauls Regulatory Bodies,” Pink Sheet (March 13, 2018)
- Quoted, “CFDA Issues Guidelines for Using Foreign Device Trial Data,” International Devices & Diagnostics Monitor (January 22, 2018)
- Quoted, “China FDA to Require Registration, Training of Medical Reps,” International Devices & Diagnostics Monitor (January 8, 2018)
- Co-author, “China's FDA Reform Will Encourage Life Science Innovation,” Law360 (November 15, 2017)
- Quoted, “China Cuts Drug Approval Timelines, Sets Tough Penalties On Individuals Violating R&D Or Safety Rules,” Pink Sheet (November 1, 2017)
- Quoted, “China's New Device Catalogue Makes Significant Classification Changes,” FDA News Device Daily Bulletin (October 3, 2017)
- Quoted, “Medtech Advised To Prepare For Significant Updates In China’s Classification Catalogue,” Medtech Insight (September 8, 2017)
- Quoted, “Clinical Data Forgers Face Harsh Punishment in China,” Pink Sheet (August 17, 2017)
- Co-author, “Every Single Step Counts for a Journey of a Thousand Miles,” White Paper published with McKinsey & Co. (July 2017)
- Co-author, “Life Sciences: Product Regulation and Liability in China,” Lexology (January 2017)
- Co-author, “Coping with Evolving Regulatory Challenges,” White Paper published with McKinsey & Co. (August 2016)
- Co-author, “China’s medical device market: New Policies, Higher Stakes,” White Paper published with McKinsey & Co. (September 2015)
- Co-author, “Unanswered Questions: China’s New Pharma Advertising Rule,” Law360 (August 2015)
- Co-author, “New China FDA Guidance May Speed up Device Approvals,” Law360 (June 2015)
- Author, “Biosimilars are regulated differently in China,” Pharma DJ (May 2015)
- Author, “China Liberalizes Drug Pricing Control,” China Corporate Law Service (May 2015)
- Co-Author, Chambers Legal Practice Guide: China Life Sciences (2015)
- Co-Author, PLC: Medical Product Regulation and Product Liability in China (2015)
- Author, “Major Changes Come to China's Medical Device Industry,” Law360 (April 2014)
- Co-Author, “China Anti-Bribery Rules Raise Questions for Life Sciences,” Law360 (February 2014)
- Speaker, “China’s Drug Administration Law Examined,” European Union Chamber of Commerce Pharmaceutical Working Group (October 10, 2019)
- Speaker, “Current Issues in Technology Transfer,” Ropes & Gray Roundtable (November 2, 2018)
- Speaker, “Regulatory Challenges and Solutions for Mobile Health Sector in China,” Health China and the New Norm: Mobile Health Summit (May 2015)
- Speaker, “Biologics v.s. Biosimilars: Four Questions for 2015,” Chinabio Partnering Forum (April 2015)
- Speaker, “Pharmaceutical Industry Code of Practice In and Outside of China,” Medical Affairs Essentials (November 2014)
- Speaker, “Riding the New Wave: How to Prepare Your Life Sciences Company for Compliance and Success in the Face of China's Recent Regulatory Changes,” Ropes & Gray West Coast Lunchtime Legal Briefing Teleconference (January 2014)