News

The China Certification Centre for Automotive Products (CCAP) has extended certification validity for select automotive products from 5 to 10 years, effective December 31, 2024. Learn how this impacts manufacturers and compliance processes.

China’s 2025 Action Plan signals wider market access and policy support for foreign enterprises, including medical device manufacturers.

CNCA issued Announcement No. 28 of 2024, releasing updated Implementation Rules for Mandatory Product Certification: Motor Vehicle Tires...

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

China Medical Device QMS Self-assessment Annual Report must be submitted by March 31, 2025, to avoid sales suspension, fines, and certifica...

In 2025, National Medical Products Administration (NMPA) issued the "Several Provisions on Supporting Innovation in Cosmetic Ingredients...

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....

In December 2024, China’s NMPA issued a notice regarding adjustments to the classification codes for in Vitro diagnostic reagents.|In December 2024, China’s NMPA issued a notice regarding adjustments to the classification codes for in Vitro diagnostic reagents.

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

On January 10, 2025, the NMPA released Chinese medical device regulatory data for 2024. This publication, which reflects data up to Dec...|On January 10, 2025, the NMPA released Chinese medical device regulatory data for 2024. This publication, which reflects data up to Dec...

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....

These changes aim to enhance the certification process and ensure the quality and safety of cord sets and interconnection cord sets in China.|These changes aim to enhance the certification process and ensure the quality and safety of cord sets and interconnection cord sets in China.

The SAMR recently announced the implementation of mandatory product certification for electric vehicle power supply equipment, marking an....|The SAMR recently announced the implementation of mandatory product certification for electric vehicle power supply equipment, marking an....

The new standards for motor vehicle tires in China apply to both passenger car and truck tires. The main changes are intended|The new standards for motor vehicle tires in China apply to both passenger car and truck tires. The main changes are intended

The MARA has issued new veterinary drug registration guidelines aimed at strengthening the management of veterinary drug registrations...|The MARA has issued new veterinary drug registration guidelines aimed at strengthening the management of veterinary drug registrations...

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).