Pharma & Biotech

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

The 2025 Drug Evaluation Report provides insights into key application trends, review activities, and developments across China's pharmaceutical sector.

The reformed framework overhauls policy to strengthen innovation while tightening evidence, supply, and compliance requirements.

The framework establishes filing rules, protection scope, and transitional requirements affecting innovative and overseas-originator drug applications in China.

Malaysia’s latest regulatory updates expand electronic labelling for pharmaceuticals and simplify medical device label requirements for foreign manufacturers.