Asia-Pacific Roundup: Hong Kong advances new Centre for Medical Products Regulation

RoundupsRoundups | 10 June 2024 | Nick Paul Taylor

Hong Kong’s Department of Health (DH) has created an office to prepare for the creation of the Centre for Medical Products Regulation (CMPR). The new preparatory office will propose steps for formally establishing CMPR and study potential changes to regulatory and approval regimes in Hong Kong.
 
In its 2023 policy address, the government outlined plans to leverage the medical strengths of the Hong Kong Special Administrative Region to support the long-term goal of establishing an authority that registers drugs and medical devices under the “primary evaluation” approach. Primary evaluation means directly approving medical products for use in Hong Kong based on clinical trial data, without relying on approvals from other drug regulatory authorities.
 
The government sees primary evaluation as a way to accelerate the clinical use of new drugs and medical devices and support industry. The goal is to restructure and strengthen the regulatory and approval regimes for drugs and medical devices and make Hong Kong an international health and medical innovation hub.
 
Setting up the preparatory office is the third of six steps on the government’s roadmap for establishing an internationally recognized regulatory authority. The first two steps saw Hong Kong become an observer of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and set up a new mechanism for the approval of new drugs. The “1+” mechanism allows holders of registration from one recognized drug regulatory authority to seek approval.
 
The creation of the preparatory office will support the next three steps. Officials have tasked the office with studying and planning a regulatory and approval regime for drugs and medical devices suitable for Hong Kong. The work will inform proposals for establishing the CMPR. The office will also assess the need to amend existing legislation to promote the development of medical products regulation and offer advice to the Steering Committee on Health and Medical Innovation and Development.
 
Through the work, the government is aiming to establish CMPR in 2026 or 2027. Beyond that, Hong Kong wants to establish a primary evaluation approach and secure ICH membership. The government said it typically takes eight to 10 years from initial engagement with ICH to become a regulatory member of the international organization. Hong Kong officially became an observer of the ICH in 2023.
 
While aspects of the plan are still years away from completion, the government is feeling the impact of the early steps in the strategy already. Hong Kong’s DH has received 210 inquiries from about 70 pharmaceutical companies since implementing the 1+ mechanism in November. Hong Kong has approved two cancer drugs using the mechanism, which allows companies with local clinical data to seek approval using one, rather than two, authorizations from recognized regulatory authorities.
 
Press Release
 
Singapore’s HSA clarifies patent declaration plan after receiving feedback
 
Singapore’s Health Sciences Authority (HSA) has clarified planned changes to a mechanism intended to quickly resolve potential patent disputes after receiving feedback from industry and law firms.
 
HSA began a consultation into the changes in March. The agency outlined plans to require applicants to disclose patents related to the active ingredient, the formulation or composition of the therapeutic product, and “the use of an active ingredient in the manufacture of that therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use.”
 
One-third of the 36 comments submitted to the consultation requested clarification of the types of patents affected by the regulation. In response, HSA has provided examples of the types of patents that are subject to the requirements. One example is “a patent containing a claim for the same polymorphic form of an active ingredient of that therapeutic product.”
 
HSA also provided details of the circumstances in which a patent would be outside of the scope of the requirements. For example, the polymorphic patent would not be affected by the regulation if the applicant was seeking authorization in a different indication and not infringing claims for the disease in which the original product was registered.
 
The agency also received requests for clarification of the patent declaration process. HSA responded with an explanation that “the declaration must be furnished at the time of making the application, as well as at any other such time prior to the determination of the application as HSA may require.”
 
One-third of respondents suggested additional measures for the regulation. HSA is reviewing the ideas, “taking into consideration the applicability of the measures in our local context while ensuring that Singapore’s international obligations continue to be met.”
 
HSA Notice
 
TGA outlines proactive approach to monitoring highest-risk device trials
 
Australia’s Therapeutic Goods Administration (TGA) has outlined changes to its approach to the highest-risk implantable and cardiac invasive medical devices used in first-in-human clinical trials.
 
TGA is reviewing the safety information supporting notifications for such studies as part of the 2019 Action Plan for Medical Devices. The work has led to changes to the clinical trial notification (CTN) form and legislation. TGA discussed the changes and their impact on clinical trials last week.
 
The new CTN form includes mandatory fields to better characterize the medical device in the clinical trial, for example by determining its risk classification, and identify first-in-human studies and studies halted overseas for safety reasons. Legislative changes have empowered TGA to require information about the safety of medical devices used in clinical trials and inspect studies conducted under a CTN.
 
TGA said the updated CTN, which took effect in April, is helping it identify first-in-human trials for devices at high risk of immediate, catastrophic consequences if they fail to perform. The agency may review the investigator’s brochure for such studies “to assess potential risks to trial participants and make sure appropriate mitigation strategies are in place.”
 
Sponsors can start trials once they have submitted their notifications and TGA has received payment. However, the agency’s team may ask “for further information to process the form, separate to this review process.” There will be no additional fee for the review and the process will not affect the timeline for starting studies. TGA may take further action if it finds significant safety concerns.
 
TGA Notice
 
PMDA discusses impact of Japanese GMO regulations on gene therapies
 
The Pharmaceuticals and Medical Devices Agency (PMDA) has explained how Japan’s Cartagena Act on genetically modified organisms (GMOs) affects the development of viral vector-based gene therapies.
 
PMDA’s educational video explains how Japan adopted the Cartagena Act to support the implementation of an international protocol on biosafety. The definition of GMO includes genetically modified viruses, making the rules applicable to gene therapies based on viral vectors.
 
In the video, PMDA outlines how the actions needed to comply with the Cartagena Act fit into the timeline for developing gene therapies. Two Cartagena Act approvals are needed. Sponsors need to apply for one approval before enrolling the first patient in a clinical trial. Japan requires a second approval before the start of manufacturing at an expanded scale or the start of process validation.
 
PMDA Video
 
Other News:
 
Malaysia’s Medical Device Authority (MDA) implemented electronic establishment licenses on 5 June. Establishments can download licenses from MDA’s portal once the application is complete and the agency has processed the license fee payment. MDA Notice

 

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