News
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.
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.
Draft standards would introduce a unified 37-digit barcode system and update technical requirements for veterinary equipment supplied to China.
China Customs has revised the 2026 sampling inspection program, adding and removing product categories that may face border inspections.
New Hainan MPA guidance clarifies how Lecheng real-world evidence can support imported product registration, labeling updates, and post-approval activities
China approves new food ingredients, additives, and food-contact materials, creating new formulation and compliance considerations
New data on cosmetic registrations, ingredient filings, safety assessments, and standards development reveals key compliance trends in China.
New CCC requirements add GB 47372-2026 as a mandatory certification standard and require certificate conversion for affected products
New Trial CCC rules strengthen factory oversight, product consistency, and quality management requirements for manufacturers.
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