1. Pink Sheet

Eight For 8: Things You Need To Know About China Biopharma Regulation In 2018

 
• By Brian Yang

The Pink Sheet's pick of eight major events that captured major regulatory developments in China’s dynamic, highly fluid biopharma scene in 2018.

China USA or United States trade and American tariffs conflict with two opposing trading partners as an economic import and exports dispute concept with 3D illustration elements
US Trade Dispute Among Key China Policy Issues In 2018 • Source: Shutterstock

2018 marked several historic regulatory milestones for the biopharma sector in China, among them the approval of the first domestically developed novel cancer drug, a simmering trade war with the US, and more controversially the birth of the world's first gene-edited babies. This was aside from the leaps and bounds of the country's regulatory agencies to speed up innovative new therapies' market entry.

As of Dec.7, regulators had approved 16 such products, with a focus on cancer, infectious diseases, and rare conditions.

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