Pharma & Biotech

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

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

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

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

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

New Greater Bay Area regulations for importing Hong Kong drugs and medical devices starting December 1, 2024 will reduce review time

Hong Kong 2024 Policy Address: Key regulatory updates on medical product approvals and initiatives to enhance biomedical research.

The Center for Drug Evaluation (CDE) in China accepted over 19,500 drug registration applications in 2024. Learn how evolving regulatory trends impact pharmaceutical market access for international companies.

Hong Kong CMPR will be established by 2026, with a phased primary evaluation system for new drug registration implemented through 2030.

Hong Kong 1+ pathway allows submissions based on one CPP along with additional clinical data applicable to the Hong Kong population.

China GBA reimbursement frameworks have advanced to support the GBA Connect Scheme, with six cities having individually adapted policies.

Chinese Pharmacopoeia 2020 edition was translated into English and officially published by the Chinese CPC on March 14, 2023.