Katherine Wang

Experience

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 medical technology companies on the development and commercialization of digital therapies, AI-based diagnostic equipment and instruments, internet-based or mobile patient interfaces, collaborations with hospitals for the collection of clinical and health data, cross-border data transfer and patient privacy issues.
• 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.

COVID-19 Matters

• 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.