News

China proposes ICH E6(R3) Annex 2 implementation from January 2027, with public comments open for one month from August 10 2026.

The guideline introduces more detailed evidence requirements for Hong Kong and Macao drug imports while retaining a streamlined pathway for products already approved under the GBA Connect scheme.

TC21-2026-02 introduces stricter chemical limits, enhanced safety requirements, and a 2027 compliance deadline for toys and children’s vehicles.

The revised 2026 GBA Connect Scheme framework sets higher bars for clinical need while fast-tracking repeat approvals for imported medical devices.

TC07 clarifies how companies must convert eligible CCC self-declarations to third-party certification before mandatory compliance deadlines.

The draft clarifies when CDE may issue written supplementary information requests and when major deficiencies identified during review may instead lead to a non-approval conclusion.

The R&D import whitelist scheme streamlines customs clearance while maintaining specific eligibility, traceability, and risk-control requirements.

The new edition covers license applications, processing times, renewals, and licensing changes for registered products in Malaysia.

Taiwan’s TFDA released its updated 2026 recognized medical device standards list to harmonize regulations and streamline global market access.

Taiwan TFDA requires license holders of semaglutide and tirzepatide-containing drugsto submit risk assessment and control plans within three months.

Learn the proposed changes to China’s drug traceability system requirements and the key considerations for industry stakeholders.

Circular No. 2/2026 revises prohibited, restricted, colorant, and preservative requirements for cosmetics marketed in Malaysia.

Overseas medical device manufacturers must prepare for Malaysia MDA's new hologram labeling framework designed to curb counterfeits and secure supply chains.

Understand what China’s revised medical device GMP means for quality management and digital compliance, alongside changes to classification, emerging technologies, and online sales.

Brands must audit ingredients, suppliers and packaging before January 2028 to ensure compliance with GB 7916-2026.

By shifting the focus beyond lowest-price bidding, the new policy rewards innovation, clinical performance, and long-term value in public hospital procurement.

Companies can benefit from expanded toxicology data exemptions, simplified cosmetics registration procedures, and more efficient compliance pathways

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.