Pharma & Biotech

Cisema at the Regulatory Science for Pharmaceutical Innovation and Internationalization Conference
Cisema at the Regulatory Science for Pharmaceutical Innovation and Internationalization Conference

Regulatory Science for Pharmaceutical Innovation and Internationalization Conference took place on April 28, 2024, sharing GBA market insights

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January 16, 2026
Cisema at the Regulatory Science for Pharmaceutical Innovation and Internationalization Conference
China Drug Evaluation Report 2023 issued
China Drug Evaluation Report 2023 issued

China’s Center for Drug Evaluation has released its annual report for 2023.

July 2, 2024
China Drug Evaluation Report 2023 issued
Breaking news – NMPA restarts overseas factory inspections in earnest
Breaking news – NMPA restarts overseas factory inspections in earnest

NMPA overseas factory inspection results have seen at least three medical device manufacturers notified by the authorities this week alone...

March 1, 2024
Breaking news – NMPA restarts overseas factory inspections in earnest
China Greater Bay Area demand for medical products surges by 154% in 2023
China Greater Bay Area demand for medical products surges by 154% in 2023

China Greater Bay Area demand for medical products surges as Guangzhou customs supervised over 101 batches of imported products in 2023...

January 16, 2026
China Greater Bay Area demand for medical products surges by 154% in 2023
China drug registration electronic submission requirements updates from CDE
China drug registration electronic submission requirements updates from CDE

China’s Center for Drug Evaluation has issued updates to the requirements for the electronic submission of drug registration applications.

January 4, 2024
China drug registration electronic submission requirements updates from CDE
China drug package insert accessibility guidelines issued by CDE
China drug package insert accessibility guidelines issued by CDE

China’s CDE has issued guidelines to ensure accessibility for drug package inserts. It includes simplified and large-font format requirements.

January 4, 2024
China drug package insert accessibility guidelines issued by CDE
China drug evaluation report 2022
China drug evaluation report 2022

China drug evaluation report 2022 was released by China’s Center for Drug Evaluation (CDE) in September 2023.

December 13, 2023
China drug evaluation report 2022
Breakfast Seminar on Health Technology in Hong Kong and GBA 27.11.2023
Breakfast Seminar on Health Technology in Hong Kong and GBA 27.11.2023

Breakfast seminar on health technology in Hong Kong and GBA will be carried out on November 27, 2023, at the Finland Chamber of Commerce.

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January 16, 2026
Breakfast Seminar on Health Technology in Hong Kong and GBA 27.11.2023
Hong Kong new drug application - Expedited scheme to be launched on November 1, 2023
Hong Kong new drug application - Expedited scheme to be launched on November 1, 2023

Hong Kong new drug application, fulfilling the conditional requirements, will require one overseas marketing approvals instead of two.

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January 16, 2026
Hong Kong new drug application - Expedited scheme to be launched on November 1, 2023
Pre-phase III drug clinical trial meeting guidelines released
Pre-phase III drug clinical trial meeting guidelines released

Pre-Phase III drug clinical trial meeting guidelines have been released by the NMPA CDE for trial implementation as of March 22, 2023.

May 11, 2023
Pre-phase III drug clinical trial meeting guidelines released
China chemical drug instructions and labels guidelines
China chemical drug instructions and labels guidelines

China’s Center for Drug Evaluation has released new Guidelines for Information on China Chemical Drug Instructions and Labels.

April 28, 2023
China chemical drug instructions and labels guidelines
Oral solid dosage continuous manufacturing introduced in China
Oral solid dosage continuous manufacturing introduced in China

Oral solid dosage continuous manufacturing technical guidelines have been issued by the China CDE on Mar. 21, 2023, for trial implementation

April 28, 2023
Oral solid dosage continuous manufacturing introduced in China

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