Regulatory News from Across Asia-Pacific

The CNAS issued the CNAS-EL-21: 2022 to provide guidance for applying for the accreditation for group enterprise internal laboratories.

The NMPA issued the technical review guideline for medical device-based combination products, and on drug release studies required...

The NMPA published the 14th Five-Year Plan for National Drug Safety and Promotion of High Quality Development setting goals to (i) achieve...

Cisema celebrates 20th anniversary in 2022. We strive to join German efficiency and reliability in service to our customers.

Cisema webinar on drug registration pathways will provide an overview of the regulatory environment for medicines in China.

China Water Efficiency Label will be required for a 3rd batch of products in China according to the NDRC that comes into force in July 2022

The SAMR issued a draft list of Health Functions Allowed for Non-Nutrient Supplements Health Food Claims and supporting documents

The CDE published the trial working procedures for initiating drug verification and testing with immediate effect from Jan 1, 2022, onwards.

A variety of consultation channels are offered by the CDE to enhance the support of technical guidance and services to applicants.

Measures for the quality management of cosmetics production will come into force on July 1, 2022. Production requirements shall be complied.

China electronic certificates for cosmetics registration was announced for trial implementation by the NMPA on December 30, 2021.

Overseas clinical trial data for IVD registration in China now adopts the new technical guidelines issued on December 1, 2021, by the NMPA.

8 GB standards and 19 YY/T standards have been approved whilst NMPA issued a draft list of 76 mandatory standards related to GB 9706.1-2020

Following the 6 cases reported last month, the NMPA issued another list of violations committed by medical beauty service providers in China.

New finalized emergency approval procedures for medical devices in China with scope, requirements, application procedures, etc., clarified.

According to NMPA's new classification catalogue, non-sterile liquid & paste dressings are no longer classified as a class I in China

China healthcare market update webinar was held on Dec 15, 2021, by Cisema with the EU SME Centre and the China-Britain Business Council.

New drug clinical trial applications 2020 annual report indicated a total of 2602 clinical trial applications received by the CDE.

China innovative drug approvals require pre-NDA meetings carried out in the application to address the common pharmacology issues

Cosmetics Ingredient Submission Code is required from Jan 1, 2023, onwards to cover the safety information of cosmetic ingredients in China