The Standing Committee of the 14th Guandong Provincial People’s Congress has adopted revised regulations for managing the importation of urgently needed drugs and medical devices in the Guandong – Hong Kong – Macao Greater Bay Area. These updated regulations cover the application, procurement, importation, distribution, use, and supervision of drugs and medical devices and will take effect on 1 December 2024.
Catalogue-Based System Management for Urgently Needed Drugs and Medical Devices in Hong Kong and Macao
The management of urgently needed drugs and medical devices in Hong Kong and Macao will be catalogue-based, requiring the provincial government’s drug supervision department to establish a catalogue system with mechanisms for entry and adjustment. Collaborating with the health administration department, the catalogue will be updated regularly based on clinical needs and market conditions, and later published for the public. Opinions from relevant government departments, industry stakeholders, medical institutions, pharmaceutical companies, and the public, will be considered when formulating the catalogue.
Establishment of Experts Review Database for Urgently Needed Drugs and Medical Devices in Hong Kong and Macao
The provincial government’s drug and health administration departments will develop an expert database to review urgently needed drugs and medical devices in Hong Kong and Macao. Comprising experts from universities, research institutions, and medical institutions, this database will assess the clinical urgency, advancement, and usage risks of drugs and medical devices for inclusion in the catalogue of urgently needed items.
Expedited Review Process of Urgently Needed Drugs and Medical Devices in Hong Kong and Macao
The provincial drug supervision and health departments are responsible for reviewing applications to import urgently needed drugs and medical devices for Hong Kong and Macao. If a designated medical institution applies for drugs and medical devices listed in the catalogue, the health department shall issue a review opinion within 5 working days from the date of acceptance, followed by the drug department’s approval within another 5 working days for those that meet the regulatory requirements. For unlisted drugs and medical devices, the review and approval process will take 10 days each. Expert reviews are excluded from this time limit.
Online submission and parallel reviews will streamline the process, and repeat imports will undergo simplified reviews. The authorities will regularly publish approved drugs and medical devices for institutions transparency.
Requirements for Importing Urgently Needed Hong Kong and Macao Medical Equipment and Pharmaceuticals
Any designated medical institutions seeking to import and use large medical equipment from Hong Kong and Macao are required to obtain a large medical equipment configuration license from the provincial health administration. Additionally, the provincial commerce administration must provide an import review opinion.
Pharmaceutical and medical equipment companies involved in the procurement, import, and distribution of urgently needed drugs and medical devices must meet certain qualifications, including having proper business and import/export credentials, modern logistics capabilities, and the ability to ensure full-process traceability of the products.
For more detailed information and guidelines, please refer to the original document from People’s Government of Guandong Province (here).
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