On May 22, Ropes & Gray and McKinsey & Company co-hosted the 12th Medtech Regulatory Affairs Roundtable online. Around 40 Regulatory Affairs leaders from Chinese and multinational medtech companies gathered to review and...more
Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory for purposes of clinical...more
5/30/2025
/ Asia Pacific ,
Australia ,
Centers for Medicare & Medicaid Services (CMS) ,
China ,
CLIA ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Laboratory Developed Tests ,
Medical Devices ,
Regulatory Reform ,
Singapore
Regulation of artificial intelligence (AI) in Asia Pacific remains nascent, mostly governed by existing regulatory frameworks designed for other technologies and products. It’s a work in progress. AI techniques – machine...more
Recently, the National Medical Products Administration (NMPA) issued the draft version of 'Implementation Measures for Drug Trial Data Protection (hereinafter referred to as the 'Draft for Comments'), aiming to clarify the...more
4/1/2025
/ Biologics ,
China ,
Clinical Trials ,
Data Protection ,
Drug Pricing ,
Generic Drugs ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Regulatory Requirements
Amid increasing economic tensions with the United States, China recently announced that it would ban Illumina, a U.S.-based company and the world’s leading producer of gene-sequencing machines, from importing its gene...more