Our Sectors

Pharmaceuticals

The pharmaceutical markets in China and the Far East are among the most dynamic and complex in the world, shaped by rapid innovation, evolving regulatory landscapes, and increasing cross-border activity. Health Law Asia offers specialized legal consultancy services designed to help pharmaceutical companies confidently navigate this challenging environment.
With in-depth knowledge of local regulations, including China’s National Medical Products Administration (NMPA) requirements, cross-border drug approval processes, data protection laws, and foreign investment policies, our legal team provides clear, actionable guidance tailored to each client’s operational and strategic needs.
We support clients at every stage of the pharmaceutical lifecycle—from clinical trial approvals and IP strategy to market access, licensing, and regulatory compliance across China, South Korea, Japan, Singapore, Vietnam, Thailand and other Southeast Asian Countries. Our bilingual legal experts and strategic partners on the ground ensure seamless communication and alignment with local authorities and industry standards.
Whether you are entering the market, expanding operations, or managing compliance risks, Health Law Asia is your trusted legal partner in achieving success across the Chinese and Far Eastern pharmaceutical sectors.

Practical cases:

  • Assessment on market share and reimbursement price of certain imported drugs through the analysis of auction prices in procurement tenders, combined with a comparative analysis with domestic competitors.
  • Feasibility study on registration in EU market of an API classified as neurotoxin manufactured in China by an innovative manufacturing process – Compliance analysis, IP protection study and Due Diligence on the Chinese Manufacturer.
  • Negotiation of License and Technology Transfer Agreement between a European MAH and a Chinese top-player Pharmaceutical Company to regulate MA transfer, relocation of manufacturing site from EU to China, and settlement of disputes arising from previous local distributor.
  • Opinion on data protection over EU imported drugs acknowledged in China as Reference Product (Originator).
  • Negotiation of Cooperation Agreement between a European MAH and a Chinese Pharmaceutical Company to regulate registration in PRC of an imported drug and related Clinical Trials obligations.
  • Advisory on appointment of Domestic Responsible Person of imported drugs, negotiation of the related agreement and respective liabilities between DRP and MAH.
  • Legal and Regulatory Assessment on certain imported drugs, to negotiate the ownership transfer to a new MAH.

Medical devices

Navigating the legal and regulatory terrain of the medical device industry in China and the Far East demands precision, agility, and a deep understanding of local frameworks. Health Law Asia provides dedicated legal and regulatory support to medical device companies looking to operate, expand, or comply within one of the world’s most complex and high-growth regions.

From Class I to Class III devices, market authorization in China through the NMPA, ASEAN harmonization pathways, and Japan’s PMDA requirements—our multidisciplinary team offers practical guidance that aligns with both global standards and local expectations. We assist clients in product classification, clinical evaluation filing, quality system compliance, distributor agreements, and post-market surveillance obligations.

Our strength lies in bridging regulatory insight with legal strategy. Whether your company is launching a novel device, managing a multi-country registration, or facing compliance reviews, we offer tailored solutions that reduce time-to-market and regulatory exposure.

Through our local partnerships and multilingual team, we act as an extension of your compliance and legal departments, helping you stay ahead in a rapidly evolving regulatory landscape across China, Japan, Korea, Singapore, Vietnam, Thailand, and beyond.

Practical cases:

  • Advisory in negotiations of Phase III Clinical Trial agreement between European MD holder and Chinese CRO.
  • Regulatory advisory on appointment of Hong Kong local Responsible Entity on behalf of European MD holder.
  • Dispute settlement between European MD holder and its Taiwanese distributor on regulatory handover with new distributor.
  • Advisory in market access strategy and Gap Analysis for registration in China as Drug of European MD.
  • Advisory on regulations and requirements for attendance of Centralized procurement tenders in China by imported Class III MD.

Cosmetics

The cosmetics industry in China and the broader Far East presents vast growth opportunities—but also complex regulatory demands that require informed, agile legal support. Health Law Asia provides specialized legal and regulatory advisory services to cosmetics companies operating across this diverse and fast-evolving region.

Our team assists clients in navigating market entry requirements, product registration, and ingredient compliance under China’s Cosmetics Supervision and Administration Regulation (CSAR), as well as similar frameworks in South Korea, Japan and ASEAN nations. Whether you’re launching general cosmetics or special-use products, we ensure that your formulations, claims, and labeling meet strict local standards.

We also support clients in areas such as cross-border e-commerce compliance, animal testing exemptions, IP protection, licensing arrangements, and interactions with local authorities like China’s NMPA or Korea’s MFDS. Our bilingual experts and local network offer real-time guidance and strategic insight to reduce regulatory risk and accelerate time-to-market.

With deep knowledge of regional consumer safety expectations and evolving cosmetic trends, Health Law Asia is your trusted legal partner in building a compliant, competitive, and sustainable presence in Asia’s booming beauty market.

Practical cases:

  • Opinion for an EU-Country Cosmetics Industry Association on new Chinese Regulations – focus on entrusted production and legal-regulatory duties and liabilities.
  • Opinion for a Chamber of Commerce on exemption from performance of animal testing.
  • Legal Advisory for Global Cosmetics Manufacturer on compliance management of cosmetics portfolio in China and Hong Kong.
  • Assistance on multilateral manufacturing agreements between Manufacturers, Brand-owners, Raw materials suppliers, across multiple jurisdictions.
  • Assistance on administrative punishment and blacklisting for non-compliance inspections issued by China NMPA to a foreign-invested owner of Cosmetics.

Corporate

While pharmaceutical, medical device, and cosmetics companies must meet stringent regulatory requirements for their products, success in China and the Far East demands far more than compliance alone. Health Law Asia provides end-to-end legal services that go beyond product approvals — supporting our clients in every aspect of their corporate and operational strategy.

In addition to advising on product registration, licensing, and market authorization, we assist companies with corporate structuring, joint ventures, foreign direct investment, commercial contracts, distribution and agency agreements, M&A, labor law compliance, and data protection—all tailored to the specific legal environments of China, Japan, Korea, and Southeast Asia (including Thailand, Vietnam, Singapore).

Operating in a regulated industry does not shield companies from broader legal challenges. Whether setting up a local entity, negotiating with partners, protecting IP, or navigating evolving corporate governance requirements, our team ensures that your business remains legally sound, operationally efficient, and aligned with local laws and business practices.

By integrating regulatory expertise with full-spectrum corporate legal support, Health Law Asia offers a strategic legal partnership to help your company grow sustainably and compliantly in Asia’s most promising markets.

Practical cases:

  • Assistance on Cross-Border E-Commerce policies and trade on behalf of EU Healthcare products.
  • Set-up and legal advisory on foreign-invested entities in Asian Countries for import and trade of healthcare products.
  • Advisory on IP protection on behalf of foreign owners of healthcare products and local companies for infringement.
  • Litigation on credit recovery issues between foreign manufacturers and local buyers.
  • Assistance on labor disputes between foreign employers and local HR.
  • Investigation into conflict of interest between local foreign-invested company and local managers.
  • Set up and legal advisory on joint ventures in MD trade and negotiation of technology transfer agreements.

Negotiation of dispute settlement between an EU buyer and a Chinese manufacturer of COVID-19 protective masks.

International Healthcare Cooperation

We offer strategic legal and advisory support to private and public healthcare institutions—such as hospitals, research centers, universities, and others — seeking to establish or expand international cooperation with partners in China and the ASEAN region.

Our team brings deep experience in negotiating and structuring cross-border collaborations, covering a wide range of initiatives including joint research projects, academic exchanges, clinical trial partnerships, hospital management agreements, and capacity-building programs.

Understanding the complexities of public health governance, regulatory frameworks, and institutional protocols across Asian jurisdictions is essential. We assist our clients in navigating legal, contractual, and compliance aspects when dealing with government agencies, public hospitals, and academic medical centers in China, Singapore, Thailand, Vietnam, Korea and other ASEAN member states.

Whether facilitating government-to-government MOUs, advising on PPP models, or managing legal risks in sensitive cross-border engagements, our multidisciplinary approach ensures that your partnerships are compliant, sustainable, and aligned with both institutional objectives and regional legal standards.

Health Law Asia is a trusted partner in building meaningful, lawful, and forward-looking collaborations across Asia’s evolving healthcare landscape.

Practical cases:

  • Representing a Public Institute of Care and Research (IRCCS Foundation) on negotiation of a MOU with Provincial Govt. Healthcare Commission in China.
  • Representing a Private Institute of Care and Research (IRCCS Foundation) on scouting potential partnerships in China for cooperation in Telemedicine and other research projects.
  • Representing a Private Hospital Group on explore potential partnerships in Health tourism between China and EU.