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.

 

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.

 

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.

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.