Pharma & Biotech

On March 10, 2025, the NMPA implemented new guidelines for chemical drug registration in China. Learn about stricter electronic submissions, compliance requirements, and their impact on international pharmaceutical companies.

Document No. 53, outlining comprehensive reforms aimed at strengthening the regulation of pharmaceuticals and medical devices. These reforms..

The NMPA issued a draft policy aimed at simplifying the registration and approval process for traditional oral Chinese patent medicines...|The NMPA issued a draft policy aimed at simplifying the registration and approval process for traditional oral Chinese patent medicines...

The NHSA has released the 2024 National Medical Insurance Drug List (NEDL) and launched updates regarding this year’s drug price....

The Center for Drug Evaluation (CDE) issued Traditional Chinese Medicine clinical development guidelines on November 19, 2024....

The China CDE has released new guidelines on biosimilars, Mediterranean anemia gene therapies, and patient-reported outcomes in rheumatolo...

The CDE has released three key guidelines, between September and November 2024, aimed at providing technical direction…|The CDE has released three key guidelines, between September and November 2024, aimed at providing technical direction…

The CDE of China published a draft of the Guidelines for Benefit-Risk Assessment Based on Multi-Regional Clinical Trial Data in Global....|The CDE of China published a draft of the Guidelines for Benefit-Risk Assessment Based on Multi-Regional Clinical Trial Data in Global....

One of the primary objectives of China's centralized procurement mechanism is ensuring that the medicines and medical consumables...|One of the primary objectives of China's centralized procurement mechanism is ensuring that the medicines and medical consumables...

...risks associated with segmented production and provide technical requirements for products such as Antibody-Drug Conjugates (ADCs).|...risks associated with segmented production and provide technical requirements for products such as Antibody-Drug Conjugates (ADCs).

China priority acceptance service for innovative drugs marketing applications has been introduced by the CDE on October 24, 2024, and it came into effective from November 1, 2024.|China priority acceptance service for innovative drugs marketing applications has been introduced by the CDE on October 24, 2024, and it came into effective from November 1, 2024.

China’s NMPA has announced Interim regulations on the Administration of Designated Domestic Responsible Person for Foreign Drug Marketing License Holders|China’s NMPA has announced Interim regulations on the Administration of Designated Domestic Responsible Person for Foreign Drug Marketing License Holders