Pharma & Biotech

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.

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.

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.

New NMPA packaging size guidance encourages drug applicants to align pack sizes with clinical use, patient needs, and sustainability goals.

The latest Guidelines raise the compliance bar for online prescription drug sales, with stricter oversight for pharmacies and platforms.

New ethics guidelines clarify consent, privacy, security, and governance expectations for human genetic data research in China.

New Hainan MPA guidance clarifies how Lecheng real-world evidence can support imported product registration, labeling updates, and post-approval activities