22nd December 2025 – (Hong Kong) The Department of Health (DH) has announced that, with immediate effect, prospective applicants seeking to register new medicines under Hong Kong’s “1+” registration mechanism may request one‑to‑one pre‑new drug application (pre‑NDA) meetings. The new service is intended to streamline and accelerate the assessment of innovative therapies by encouraging early engagement between regulators and the pharmaceutical industry, thereby improving the quality and efficiency of submissions and reinforcing Hong Kong’s role as an international centre for health and medical innovation.
The consultation offer forms part of a broader support framework for companies using the “1+” pathway and is made up of three elements: briefing seminars, technical workshops and the newly introduced pre‑NDA meetings. According to the DH, the pre‑NDA sessions are designed to give tailored regulatory guidance to potential applicants at an early stage, reduce procedural uncertainty and smooth the path to formal submission.
Two distinct formats of pre‑NDA meeting are available. The first is company‑oriented and targeted at firms applying through the “1+” mechanism for the first time. In these sessions, DH specialists will advise on appropriate categories of drug registration and suitable application routes, taking into account the company’s profile and pipeline of prospective products. The second format is product‑specific, focusing on an individual new drug project. For such meetings, DH professionals will set out the evidentiary expectations, procedural steps and documentation requirements relevant to that particular application, with the aim of ensuring that dossiers are complete and aligned with regulatory standards from the outset.
Practical information on how to request these one‑on‑one pre‑NDA meetings has been published on the dedicated “1+” mechanism webpage. To encourage take‑up from the sector, the DH has indicated that no fees will be levied for the service at this stage. The department also pledged to maintain close dialogue with industry stakeholders and to collect feedback and suggestions on the format and effectiveness of the meetings, with a view to further refinement over time.
The DH highlighted that since March it has already held seven briefing seminars to explain the basic requirements and procedural framework for new drug registration under the “1+” mechanism. In addition, three workshops have been conducted to offer more detailed guidance, share good practices and present real‑world case experience related to applications filed through the scheme. These outreach activities have reportedly been well received, attracting more than 580 participants from pharmaceutical companies, consultancy houses and research institutions both within and outside Hong Kong. Presentation materials and logistical details for past seminars have been made available on the “1+” thematic webpage. The DH said it will continue to organise further workshops and briefings as necessary in response to industry demand and feedback, as it seeks to bolster the efficiency and predictability of the city’s new drug approval process.
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