Pharma & Biotech

Importing drugs and medical devices from Hong Kong have been approved and amounted up to 15 products into the GBA as of March 2022.

Clinical trials GMP management specification first issued its draft in July 2018. The appendix draft was issued on January 18, 2022.

Acceptance and examination of chemical APIs trial guidelines have had its first draft issued in April 2020.

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

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.

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

Improve the management of the electronic filing for drug registration applications, the NMPA developed and promoted the eCTD.

The NMPA has developed and built an API production and supply information collection module in the drug information collection platform.

The State Administration for Market Regulation addressed the innovative development plan actions for drugs and medical devices in the Greater Bay Area.

Cisema has the capability to help you comply with Hong Kong MDACS requirements and expand your businesses in the Greater Bay Area