Asia Pacific Roundup: Hong Kong targets 2026 launch for Centre for Medical Products Regulation

The Hong Kong Department of Health has unveiled the timetable for launching its Centre for Medical Products Regulation (CMPR) and starting to approve medical products directly.

In 2023, government officials announced a long-term goal of establishing a regulatory agency to authorize drugs and medical devices without relying on approvals from other drug regulatory agencies. Officials set up an office to put forward proposals for establishing CMPR and otherwise prepare Hong Kong for the changes last year.

The work has generated a roadmap for turning Hong Kong into “an international health and medical innovation hub,” according to a statement from the Department of Health. Officials plan to create CMPR by the end of 2026 and aim to implement “primary evaluation,” the term Hong Kong uses for direct approvals, the same year. However, officials expect the full implementation of primary evaluation to take until 2030.

Officials have created a list of tasks they must complete to establish CMPR. The project will involve enacting legislation to empower CMPR to regulate Western and Chinese medicines and establish a statutory framework for regulating medical devices. Officials also plan to deepen collaboration between stakeholders and regulatory authorities in Hong Kong, mainland China, and overseas.

Other objectives include continuously improving professional capacity and regulatory efficiency, implementing primary evaluation in stages, and using the Chinese Medicine Development Blueprint to optimize the regulation of traditional products. The Health Bureau plans to publish the blueprint in the fourth quarter.

Hong Kong’s path to primary evaluation began in 2023 by implementing a “1+” mechanism, which allows companies with local clinical data and approval by at least one global reference regulatory agency to seek approval. Officials extended the program to cover all new drugs last year.

In parallel, the health department has been issuing good practice guides, enhancing the electronic registration platform, introducing new registration pathways, and creating a new fee-charging mode to prepare for primary evaluation. The initial phases of the implementation will cover new indications, strengths, and dosage forms for chemical and biological entities already registered in Hong Kong.

Ronald Lam, director of health in Hong Kong, said the phased implementation will “progressively establish a robust approval system, providing strong momentum for the development and market expansion of the healthcare industry” in Hong Kong, mainland China, and beyond.

Press Release

DRAP updates guidelines for good clinical practice inspections in Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) has finalized the third edition of its guidance on conducting and reporting good clinical practice (GCP) inspections.

DRAP released a draft version of the guidelines for consultation in May. The draft proposed changes, such as adding information on the risk-based selection of clinical trials. DRAP outlined plans to create a scoring system for quantifying risks, informing inspection priorities, and establishing a competency framework for GCP inspectors.

Most of the final version is unchanged from the May draft, with edits to large sections of the text limited to typographical tweaks. The one significant change is the deletion of a section on reporting GCP inspections. The draft guidance, like the final second edition published in 2024, included a section that described what happens after a GCP inspection.

DRAP provided an overview of the content of inspection reports, explained the timeline for creating the documents, and outlined the need to establish a corrective and preventive action plan. The agency has deleted the information from the final copy of the third version of the guideline.

The retention of the additional information proposed in the draft guidance means the final guideline establishes a way to “proactively identify, assess and manage potential risks that could affect the quality, safety and integrity of the trial and the well-being of participant.” DRAP will assess risks related to the trial, sponsor oversight, site performance, patient safety, data integrity, and regulatory or public interest.

DRAP Guidelines

New Zealand’s Medsafe receives support for changes to ADHD restrictions

A public consultation has shown support for plans to change the regulatory and funding restrictions for stimulant treatments for attention deficit hyperactivity disorder (ADHD) in New Zealand.

The Medicines and Medical Devices Safety Authority (Medsafe) and Pharmac, the group that decides what products are subsidized in New Zealand, began a consultation into stimulant treatments for ADHD in December. Medsafe and Pharmac proposed allowing additional healthcare practitioners to start patients on ADHD stimulant medications to improve access to treatment.

Medsafe wants to make changes to address undiagnosed ADHD and waitlists, which it said reflect issues with access to care. More than 70% of respondents agreed nurse practitioners should be able to start patients 17 years and under on the treatments. Agreement with the proposal was the lowest among medical practitioners, with only 17% backing the idea, but Medsafe said changes are needed.

“The status quo is not recommended. From public feedback and consultation with key stakeholders, we have determined that changes are needed to support better services for patients with ADHD in New Zealand,” Medsafe said. “This has been further highlighted from the feedback to this consultation.”

Medsafe received similar responses to a question about enabling medical practitioners with a vocational scope in general practice to initiate prescribing for patients aged 18 and over. Again, overall support for the idea masked a low rate of agreement among medical practitioners.

The agency has made tweaks to tackle perceived risks. The new prescribing rules take effect in February.

Medsafe Notice

CDSCO clarifies requirements for outsourcing device sterilization in India

The Central Drugs Standard Control Organization (CDSCO) has clarified the regulatory requirements for outsourcing medical device sterilization activities in India.

CDSCO said that stakeholders have, from time to time, raised concerns regarding a requirement of “loan license for outsourcing sterilization activity at the site of another facility having [a] valid license to carry out sterilization process of medical devices under Medical Device Rules, 2017.” The concerns led the Drugs Consultative Committee (DCC) to form a subcommittee to examine the topic in 2023.

Last week, CDSCO said the “subcommittee is of the opinion that the requirement of loan license may not be insisted, as the final product is released from the actual manufacturing site and manufacturer is monitoring the entire QC check before release.” The subcommittee concluded licensed facilities can carry out sterilization work “by way of mutual third-party agreement.”

“The DCC agreed with recommendations of the subcommittee subject to inclusion of an appropriate mechanism for submission of documentary evidence to the licensing authority in support of such activity prior to obtaining the manufacturing license,” CDSCO said.

Documentary evidence may include the mutual agreement between the device manufacturer and the sterilization site or quality management system documents mentioning the details of the outsourced activity. The committee recommended that the sterilization site's license number be listed on the device label.

CDSCO Notice

Other news

Australian border officials have found counterfeit versions of Novo Nordisk’s oral GLP-1 drug Rybelsus. TGA said the products appear genuine, but Novo has confirmed that the batch number is fake. TGA also disclosed the seizure of substandard Fitaro semaglutide pre-filled syringes at the Australian border. The syringes contain less than the stated amount of semaglutide. Rybelsus, Fitaro

Asia Pacific Roundup: Hong Kong targets 2026 launch for Centre for Medical Products Regulation

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