Pharma & Biotech

China Reference Listed Drugs application requirements for Chemical Generic Drugs
China Reference Listed Drugs application requirements for Chemical Generic Drugs

China Reference Listed Drugs (RLD) application requirements for Chemical Generic Drugs was issued by the CDE in 2022.

July 9, 2024
China Reference Listed Drugs application requirements for Chemical Generic Drugs
China Contract Drug Manufacturing Provisions
China Contract Drug Manufacturing Provisions

China Contract Drug Manufacturing Provisions were issued back in October 2023 to strengthen the supervision and management of the entrusted production of drugs.

June 20, 2024
China Contract Drug Manufacturing Provisions
Hong Kong Drug Office Implements 60-day Refuse-To-File Requirement
Hong Kong Drug Office Implements 60-day Refuse-To-File Requirement

To improve the review process, a 60-day response period allows applicants to address any deficiencies identified by the Hong Kong Drug Office

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January 16, 2026
Hong Kong Drug Office Implements 60-day Refuse-To-File Requirement
Drug registration in China – transferring overseas production to China made easier
Drug registration in China – transferring overseas production to China made easier

China is making it easier to transfer registrations of drugs initially manufactured abroad to Made-in-China status to improve availability and accessibility to medicines.

May 30, 2024
Drug registration in China – transferring overseas production to China made easier
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

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