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, CTAs, 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 privately-owned medical device manufacturers headquartered in the US 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.
- 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.
- Quoted, “China FDA Allows Self-Inspections for Device Distributors,” International Devices & Diagnostics Monitor (June 27, 2016)
- Quoted, “China Tightens Rules on Vaccine Distribution,” Bloomberg BNA (June 21, 2016)
- Quoted, “China GCP Update Covers Informed Consent, Record Retention”, International Devices & Diagnostics Monitor (April 4, 2016)
- Quoted, “Panacea or Problem,” China Business Law Journal (March 2016)
- Quoted, “New Strategies Needed As China Shakes Up Drug Classes?”, Pharmasia News (Mar 16, 2016)
- Co-author, “China’s medical device market: New Policies, Higher Stakes”, white paper published with McKinsey & Co. (September 1, 2015)
- Quoted, “China Acts To Improve Safety And Review Of Medical Devices,” Scrip Regulatory Affairs (August 24, 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)
- Quoted, “China FDA issues 'user-friendly' guidance on medical device registration studies; waivers may prove a challenge,” Scrip Regulatory Affairs (May 29, 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)
- Quoted, “Picking a Path: CDE Debuts Biosimilars Guidelines,” CPB Review (April 2015)
- Quoted, “China to Allow Biosimilar Reference Products Approved Elsewhere,” International Pharmaceutical Regulatory Monitor (April 2015)
- Quoted, “Medtech and Pharma: Heed Stricter China Clinical Trial Rules for Hospitals,” Scrip Regulatory Affairs (October 2014)
- Quoted, “Doctor on Call: Reformers Dial-up Dose of Telemedicine,” China Pharma and Biotech Review (September 2014)
- Quoted, “China Wants “Made in China” Orthopedics,” Orthopedics This Week (September 2014)
- Quoted, “Faster Reviews and New Incentives: China Contemplates Spurring Pediatric Drug Development,” Scrip Regulatory Affairs (July 2014)
- Author, “Major Changes Come to China's Medical Device Industry”, Law360 (April 2014)
- Quoted, “The risks and opportunities for pharma under China’s new rules,” Scrip Regulatory Affairs (March 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)
- Moderator, “Medical Devices: How New Rules Will Impact Your Business,” FDLI’s International Conference: China-US Updates in Food and Drug Law (October 2013)
- Speaker, “China Entry through Joint Ventures,” China Forum 2013 (October 2013)
- Speaker, “Responding to Regulatory and Reimbursement Challenges to Pharma Sales and Marketing,” China Pharmaceutical SFE & Marketing Excellence Conference (November 2013)
- Speaker and Moderator, “New Biosimilar Regulation: Challenges and Opportunities in China” and “Medical Device Innovation: From Bench to Bedside,” DIA China Annual Meeting (May 2013)
- Speaker, “Stem Cells: Perspectives on Intellectual Property and Regulation,” Ropes & Gray Tokyo Morning Briefing Teleconference (February 2013)
- Speaker, “Navigating China's Complicated Life Sciences Regulatory System for Commercial Success,” Ropes & Gray West Coast Lunchtime Legal Briefing Teleconference (January 2013)