News
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.
MDA will issue only electronic establishment licenses, affecting medical device manufacturers, importers, and distributors.
Indonesia removes IDAK renewals, mandates SDAK and IPAK transitions, and shortens correction timelines under risk-based licensing.
New WHO CRP pathway enables faster MDA review of eligible WHO-prequalified IVDs.
New policy streamlines COVID-19 Antigen RDT registration and renewal applications.
New MDA guidance introduces a risk-based framework for managing post-registration medical device changes, including software updates and SaMD.
Applicable for new registrations, renewals, and variations, the Standardized Medical Device Specification Template improves data consistency and regulatory review efficiency.
Vietnam's temporary suspension of key food registration provisions creates a transitional regulatory environment, particularly affecting health supplement companies.
The 2025 Drug Evaluation Report provides insights into key application trends, review activities, and developments across China's pharmaceutical sector.
The full implementation of the reliance program creates new opportunities for manufacturers to accelerate regional market entry by strategically leveraging approvals across both jurisdictions.
The reformed framework overhauls policy to strengthen innovation while tightening evidence, supply, and compliance requirements.
Get in Touch with Our Consultants
And discover how we can support you.