Wednesday, 4, March, 2026 / Published in Hong Kong, News, Pharma & Biotech

Hong Kong to Regulate Medical Gases as Pharmaceutical Products from June 2026

Hong Kong will begin regulating medical gases in cylinders as pharmaceutical products under the Pharmacy and Poisons Ordinance (Cap. 138)…

Tuesday, 24, February, 2026 / Published in Hong Kong, Medical Devices, News, Pharma & Biotech

Guangdong MPA Publishes 2025 GBA Connect Scheme Medical Products Catalogue

On February 2, 2026, the Guangdong Provincial Medical Products Administration (GDMPA) and the Guangdong Provincial Health Commission published the updated…

Friday, 16, January, 2026 / Published in Hong Kong, IVDs, News, Pharma & Biotech

Hong Kong Launches Pre-NDA Meetings Under the “1+” Drug Registration Mechanism

The Department of Health (DH) announced the operational launch of Pre-New Drug Application (Pre-NDA) meetings on December 22, 2025. This…

Thursday, 15, January, 2026 / Published in Hong Kong, Medical Devices, News, Pharma & Biotech

Guangdong MPA Adds 27 Designated Hospitals to the GBA Connect Scheme

On December 26, 2025, Guangdong’s Ministry of Public Administration (MPA) and the Guangdong Provincial Drug Administration (GPDCA) unveiled the fourth…

Tuesday, 9, September, 2025 / Published in Fairs & Events, Hong Kong, News, Pharma & Biotech, Seminars, Webinars

Webinar: Strategic Guide for Life & Health Tech Ventures – Navigating Hong Kong’s Regulatory Pathways for GBA Expansion

Cisema is pleased to co-present a strategic webinar with Hong Kong Science Park (HKSTP), offering insights into Hong Kong GBA regulatory…

Tuesday, 12, August, 2025 / Published in China, Hong Kong, Medical Devices, Medical Devices, News, Pharma & Biotech, Pharma & Biotech

China GBA Reimbursement and Regulatory Updates: Advancing Integration of Hong Kong Medical Products in Mainland China

China’s Greater Bay Area (GBA) reimbursement frameworks have progressed to support the GBA Connect Scheme, with six mainland cities—Guangzhou, Shenzhen,…

Friday, 27, June, 2025 / Published in Hong Kong, News, Pharma & Biotech

Hong Kong 1+ Mechanism: Accelerating Access through New Drug Applications

The Hong Kong 1+ pathway for new drug applications (NDAs) allows submissions based on prior approval from one trusted regulatory…

Friday, 27, June, 2025 / Published in Hong Kong, Medical Devices, News, Pharma & Biotech

Hong Kong CMPR Regulatory Framework and Primary Evaluation Rollout in Phases

Hong Kong CMPR, scheduled to be established by the end of 2026, was announced by the Department of Health (DH)…

Friday, 2, May, 2025 / Published in Hong Kong, News, Pharma & Biotech, Pharma & Biotech

CDE 2024 Drug Review Report: Growth in Drug Registration and Regulatory Developments in China

In 2024, the Center for Drug Evaluation (CDE) accepted 19,563 drug registration applications, marking a 5.73% increase from the previous…

Tuesday, 29, October, 2024 / Published in China, Hong Kong, Medical Devices, News, Pharma & Biotech, Pharma & Biotech

GBA Connect Scheme: 25 New Designated Hospitals and 7th Batch of Approvals

The GBA Connect Scheme is significantly enhancing healthcare accessibility within the Greater Bay Area (GBA). Recently, the program expanded its…