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, pricing, reimbursement, clinical studies, promotional practices, and product safety issues. Katherine provides day-to-day counseling on issues that life sciences companies face in relation to their interaction with agencies including the China Food and Drug Administration (CFDA), the National Health & Family Planning Commission (NHFPC) and the Administrations of Industry and Commerce (AICs), 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.
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.
- 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 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.
- Routinely represents multinational pharmaceutical and medical device companies in matters relating to their clinical studies in China, particularly concerning 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.
- Advised several US-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 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.
- Represented one of the top 5 medical device manufacturers in its strategi collaboration with Wuhan Asia Heart Hospital as a part of its global value-based healthcare 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 leading biopharmaceutical companies on biosimilar strategies in China.
- Advised several multinational pharmaceutical and medical device companies on market access issues in China, particularly related to pricing, reimbursement, tendering, and patient assistance programs.
- 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.
- 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 leading US-based healthcare 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 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.
- Author, “Regulation on the Supervision and Administration of Medical Devices amended,” International Law Office Corporate Healthcare & Life Sciences Newsletter (June 28, 2017)
- Author, “CFDA Calls for Comments on Key Policy Proposals,” International Law Office Corporate Healthcare & Life Sciences Newsletter (May 31, 2017)
- Quoted, “Bring on Clinical Studies” China Steps Up to Facilitate New Drug Entry,” Pink Sheet (May 25, 2017)
- Quoted, “China Makes Strides Toward Western Drug, Device Standards,” Bloomberg BNA’s Life Sciences Law & Industry Report (May 19, 2017)
- Cited, “CFDA Plans Major Reforms in Approvals and Clinical Trial Processes,” Drug Industry Daily (May 16, 2017)
- Quoted, “China FDA Proposes Sweeping Reforms to Incentivize Innovation,” Pink Sheet (May 15, 2017)
- Quoted, “Fake Clinical Data No More: China to Criminalize Forgery,” Pink Sheet (April 18, 2017)
- Quoted, “New Guidelines to Make China a More Drug-Friendly Market,” BioPharma Dive (April 3, 2017)
- Quoted, “Now is the time. Rule Changes to Smooth China New Drug Approvals,” Pink Sheet (March 21, 2017)
- Co-author, “Life Sciences: Product Regulation and Liability in China,” Lexology (January 31, 2017)
- Co-author, “Coping with Evolving Regulatory Challenges”, white paper published with McKinsey & Co. (August 2016, 2016)
- Co-author, “China’s medical device market: New Policies, Higher Stakes”, white paper published with McKinsey & Co. (September 1, 2015)
- Co-author, “Unanswered Questions: China’s New Pharma Advertising Rule,” Law360 (August 26, 2015)
- Author, “What the new Drug Administration Law brings,” International Law Office’s Healthcare & Life Sciences – China (July 1, 2015)
- Co-author, “New China FDA Guidance May Speed up Device Approvals,” Law360 (June 17, 2015)
- Author, “Biosimilars are regulated differently in China,” Pharma DJ (May 25, 2015)
- Author, “China Liberalizes Drug Pricing Control,” China Corporate Law Service and Ropes & Gray Alert (May 12, 2015)
- Co-Author, Chambers Legal Practice Guide: China Life Sciences (2015)
- Co-Author, PLC: Medical product regulation and product liability in China: overview (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)
- Author, “Multinational Pharmas: Expect Key Policy Shifts in China”, Law360 (December 2013)
- Co-Author, “China Offers New Possibilities for Drug License Transfers,” Update (May/June 2013)
- Author, “Navigating China’s Regulatory Landscape for Commercial Success," Pharma (June 2013)
- Author, “Pharma Cos., Scan Your Drugs for Proper Barcodes,”Law360 (February 2013)
- Chaired 2016 Medical Device Regulatory Affairs Roundtable in Beijing
- Co-chair, “Recent China Food and Drug Administration Regulatory Changes and Best Practices,” Ropes & Gray Medical Device Regulatory Affairs Roundtable, co-organized with McKinsey & Co. (May 2015)
- 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, “Regulatory & Policy Trends and Business Implications for Medical Device Players in China,” Ropes & Gray Medical Device Roundtable (April 2015)
- Speaker, “Pharmaceutical Industry Code of Practice In and Outside of China”, Medical Affairs Essentials (November 2014)
- Panelist, “Pharmaceutical Promotional Compliance”, China Medical Affairs Summit (September 2014)
- Speaker, “Latest CFDA Initiatives and Their Impact on Commercial Operations,” Ropes & Gray Medical Device Roundtable (April 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)