Members of our practice group have been providing long-term assistance to local and foreign pharmaceutical firms and healthcare institutions on matters related to medical care and pharmaceutical products, including drug procurement, drug price investigation, clinical trials, marketing and promotion of drugs, drug registration, drug relief, disputes related to medical care, etc.We have also been assisting local pharmaceutical associations as well as medical device associations in the formulation, enforcement and investigation and handling of disputes related to the regulation of pharmaceutical marketing and the Medical Device Act since 2017.
Since our clients are mostly multi-national pharmaceutical firms, we have accumulated an abundant of experience in handling matters for multi-national pharmaceutical firms that place much emphasis on ethical rules and standard operation procedures. We understand the needs of our clients and can provide tailored services that meet our clients' needs.
In addition, this practice group has plenty of experience in handling matters related to investigation, seizure and prosecution seizure of counterfeit/forbidden drugs, drug patent protection, patent linkage, and generics competition and has frequently help clients to plan relevant strategic actions and implement relevant legal actions. In addition, during the COVID-19 pandemic, our practice group assisted our pharmaceutical clients with regulatory and contractual issues related to the marketing and supply of drugs for the prevention and treatment of COVID-19.
Scope of Services
- Regulatory advice on marketing authorization, market entry, project import, EUA of drugs and medical devices, government taking, liability for compensation, and regulatory protection of drugs (data exclusivity and market exclusivity)
- Consultation regarding drug listing, determination and adjustment of reimbursement price, and PVA/MEA under national health insurance
- Marketing and promotion of drugs and medical devices, regulatory consultation on drug listing in procurement and contract review, and patient support programs
- Clinical trial, human subject research, authorization and use of medical/healthcare information, and cell therapy related legal consultation and contract review
- Consultation on adverse reaction reporting of drugs and medical devices, drug injury relief, and relevant dispute
- Consultation on licensing, technology transfer, OEM/ODM of drugs and medical devices, and contract review and due diligence thereof
- Negotiation of drugs and medical devices distribution/consignment agreement (including 3PL and 4PL)
- Regulatory advice on market entry, post-marketing product liability, and recall of food, animal drug, tobacco, alcohol, and other consumer products, and administrative investigation and related administrative remedy