News

Updated MDACS guidance creates a new pathway for qualifying technologies and outlines the evidence required for priority consideration.

Explore the latest data on China’s clinical research landscape, including record trial activity, shorter development timelines, and emerging R&D trends.

The 12th national VBP round introduces tighter quality, manufacturing, and IP requirements that pharmaceutical companies must meet to compete.

New NMPA CDE guidelines define CTMP and GTMP boundaries, affecting development strategy, CMC planning, and regulatory engagement in China.

China's updated National Essential Medicines List expands access to innovative medicines, creating new opportunities and strategic considerations for pharmaceutical companies.

China's NMPA expands priority review eligibility for chemical API marketing authorization applications, supporting domestic API production and drug supply.

China's 2026 enforcement priorities expand scrutiny of pharmaceutical sales, procurement, pricing, data security, and compliance across the healthcare sector.

MIIT expands China's RoHS product scope, adds four restricted substances, and introduces new exemptions with compliance deadlines from August 2027.

Learn how Vietnam's Ministry of Health is implementing risk-based product quality management under Decree No. 37/2026/ND-CP and what it means for regulated businesses.

The ten Good Machine Learning Practice principles covering the design, development, validation, use, and post-market management of AI medical devices.

Manufacturers seeking MRI registration in China must meet expanded technical, software, and validation requirements.

The new documents clarify expectations for Tier III variants, companion diagnostic clinical evaluation, tissue and plasma registration, and HLA-B*58:01 analytical validation.

As of July 1, 2026, Taiwan has completed its cosmetic GMP rollout, extending mandatory ISO 22716-based manufacturing standards to nearly all cosmetic factories

New NCI rules reduce administrative burden, streamline dossiers, and expand opportunities to reuse existing safety data.

Review China's new draft standards for cosmetic cheilitis and contact urticaria before the August 15, 2026, consultation deadline.

China's new BCI medical device guidance establishes classification and naming principles, giving manufacturers a clearer pathway to NMPA registration.

HSA now requires CMC validity declarations and accepts eCTD submissions, strengthening therapeutic product registration requirements.

Taiwan's TFDA will reduce clinical trial submission documents and ease decentralized trial requirements for sponsors from July 1, 2026.

New rules strengthen data governance and raise sponsor oversight duties from September 2026.

New rules expand platform accountability and regulatory oversight, reshaping how pharmaceutical products are promoted, sold, and controlled online.