The Year of the Dragon stands as a fitting emblem for Hong Kong’s medicines regulatory system, symbolising strength, resilience, and vigilant oversight.
Introduction
The regulatory authority overseeing medicines in Hong Kong is the Pharmacy and Poisons Board under the Department of Health. To ensure safety, efficacy and quality, medicines are required to be registered under the Pharmacy and Poisons Ordinance Cap 138. Applications for registration of products manufactured outside of Hong Kong must be submitted by a local representative, agent or distributor of the overseas manufacturer.
Why include Hong Kong as part of your global development strategy?
The Hong Kong pharmaceutical market is significant, reflecting an advanced healthcare system and high standards for medical care. The demand for medicines is driven by factors such as an aging population, increasing healthcare awareness, and a well-established regulatory framework. Hong Kong also serves as a gateway to the broader Asian market, which includes countries with large and growing populations. Including Hong Kong in your global regulatory strategy allows for easier access to the region, presenting opportunities for market expansion and growth.
With advocacy by key stakeholders, including international regulatory authorities for mutual recognition agreements, expedited or abbreviated pathways and information sharing between international and ASEAN regulatory agencies, the integration of Hong Kong into global development plans and commercialisation strategies is poised to become even more critical in the future.
The Hong Kong pharmaceutical market is significant, reflecting an advanced healthcare system and high standards for medical care.
Insights into how medicines are regulated in Hong Kong
The Pharmacy and Poisons Board collaborates with other international regulatory bodies and follows guidelines from both ICH and ASEAN. Although eCTD is not currently used in Hong Kong, the registration dossier should be presented in ICH CTD format. The submission is provided electronically through the online application portal with individual documents uploaded in the appropriate location. For this reason, hyperlinking within documents is required, but between documents is not viable. All documents should be provided in text searchable pdf format, with a table of contents, hyperlinks and bookmarking to aid navigation through the dossier. The application dossier can be provided in either Chinese or English.
Interestingly, the Pharmacy and Poisons Board does not consider intellectual property when reviewing the registration application. Applicants should conduct their own review to be sure there are no patents that may impact the ability to market the product within Hong Kong.
The Pharmacy and Poisons Board collaborates with other international regulatory bodies and follows guidelines from both ICH and ASEAN.
New Drug Applications (NCE/NBE)
Unlike other regulators, at this time the Hong Kong Drug Office does not have any formal procedures for orphan drug designation, breakthrough therapy designation, priority review designation or equivalent. There is no expeditated pathway relying on a foreign regulator’s evaluation of the product, even though evidence of approval of the product in two or more reference countries is required (Free Sale Certificates / Certificate of a Pharmaceutical Products) as part of the registration application. This requirement may be waived (on case-by-case basis) if there is local unmet medical need for the product.
For NCEs, the proposed Risk Management Plan (RMP) and/or Risk Evaluation and Mitigation Strategy (REMS) to be implemented in Hong Kong should be provided. The RMP/REMS should consider the identified actual and potential risks of the product, with reference to the RMP and/or REMS as required by the drug regulatory authorities of any reference countries.
For registration of a new drug substance, submission of samples is required. However, samples are not required for drug product, only colour photos or scanned images of the product, clearly showing the complete content of the prototype sales pack and its component(s). Images must include any inner container/packaging and the unit dose form image of the product.
The application review typically takes 12-18 months, however, there are no official published timelines. The review timeline will depend on the quality of the dossier, the number of rounds of evaluation queries and the timely response to agency queries.
Generic and biosimilar registrations have a number of specific application requirements depending on the marketing history of the originator product.
The recent launch of Adjutor Hong Kong signifies a pivotal step toward enhancing the services offered to our clients.
CMC consideration
Separate applications are required for different strengths, dosage form, presentations and volume of the same product. A single application can be used for a non-injectable product which differs only in package size.
Where multiple sites are involved in the manufacturing activities, the role of each site should be clearly defined. A declaration or flow chart to describe the manufacturing process may be required. PIC/S standards apply to all manufacturing sites and GMP Certificates are required to support the application.
Local knowledge is everything!
The recent launch of Adjutor Hong Kong signifies a pivotal step toward enhancing the services offered to our clients. We can
- Act as the local market authorisation holder
- Support with your publishing needs
- Provide effective strategies to navigate the regulatory pathway successfully.
- Provide expert advice to minimise evaluation queries and accelerate approval.
- Assist you stay across the latest updates, requirements, and nuances specific to medicine regulation in Hong Kong and the region.
Adjutor Healthcare can be your local market authorisation holder, publisher, regulatory strategist. We can help you achieve accelerated approval and will keep you across the latest updates/requirements.
Local knowledge is everything!
For more information on how we can assist you with your product development needs in Hong Kong.
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Disclaimer:
The information provided is intended for general informational purposes only and does not constitute legal, professional, or any other type of advice. While every effort has been made to ensure the accuracy and reliability of the information, the authors make no representations or warranties, express or implied, regarding the completeness, suitability, or applicability of the content to specific products or situations.
