Published on
Last updated on
Approval of Clinically Urgent New Drugs
On 30.10.2018, the NMPA (former NMPA) issued guidelines for the approval process of clinically urgent new drugs (NMPA No. 79-2018). The product range, selection criteria, review procedure, and requirements for the application documents were specified.
Connect with Cisema
With more than 20 years of experience and a team of over 100 specialists, Cisema helps global companies achieve compliance across Asia Pacific with confidence and accelerate market entry.
Stay Informed with Monthly News and Analysis
Stay informed with the latest regulatory changes, expert insights, and market opportunities across APAC, delivered straight to your inbox.
Related News
China Expands MRI Registration Requirements Under New 2026 Review Guideline
Manufacturers seeking MRI registration in China must meet expanded technical, software, and validation requirements.
China CMDE Releases New Review Documents for Oncology NGS & HLA-B*58:01 Reagents
The new documents clarify expectations for Tier III variants, companion diagnostic clinical evaluation, tissue and plasma registration, and HLA-B*58:01 analytical validation.
Taiwan Extends Cosmetic GMP Requirements to Nearly All Manufacturing Sites
As of July 1, 2026, Taiwan has completed its cosmetic GMP rollout, extending mandatory ISO 22716-based manufacturing standards to nearly all cosmetic factories