Asia-Pacific Roundup: Malaysia and Singapore start pilot to fast-track medtech launches

Malaysia’s Medical Device Authority (MDA) and Singapore’s Health Sciences Authority (HSA) unveiled a pilot program that could accelerate access to Class B, C, and D medical devices. The pilot program begins on 1 September and runs through 28 February.

The agencies hope the pilot will lead to faster approvals, reduced duplication of reviews, and earlier patient access to safe, innovative, and high-quality medical technologies. They aim to do so by relying on each other’s assessments and approvals.

Devices registered with HSA may undergo an abridged review through MDA’s conformity assessment body. The verification route reduces the review time to 30 working days from 60 under the full conformity assessment route. Devices registered with MDA will benefit from an abridged review by HSA, reducing review times by 30% across all Class B to D medical devices.

The pilot will test streamlined pathways, refine and establish standard operating procedures, validate shortened processing timelines, and gather feedback. The work is part of a broader cooperation between the two agencies.

“This strategic partnership seeks to diversify market opportunities, strengthen technical confidence in the medical device regulatory system, and stands as a testament to the close and enduring relationship between Malaysia and Singapore,” Muralitharan Paramasua, chief executive at MDA, said.

MDA announced the pilot with HSA shortly after setting up a similar arrangement with China’s National Medical Products Administration. The agreements grant companies with device authorizations in China or Singapore with fast-tracked access to the Malaysian market. Equally, companies with approvals in Malaysia benefit from streamlined access to China and Singapore.

Press Release

Theft of Novo Nordisk obesity, diabetes drugs in transit in India triggers CDSCO alert

India’s Central Drugs Standard Control Organization (CDSCO) has published an alert about several Novo Nordisk diabetes and obesity drugs that were stolen in transit.

Novo contacted CDSCO after batches of its insulin products, Ryzodeg and Fiasp, and three doses of its GLP-1 obesity drug Wegovy were stolen. The theft happened as the six batches were being transported from Novo’s hub in Bhiwandi to distribution routes to Nagpur, Raipur, Cuttack and Kolkata.

CDSCO published an alert about the theft because the quality of the products could be compromised if they are kept outside of the proper storage conditions. As injectables originating from recombinant DNA, the medicines need to be stored between 2-8 degrees Celsius. Failure to keep the products within the temperature range could impact product quality and ultimately pose a risk to patient safety, CDSCO said.

The theft comes two months after eight people, including pharmaceutical company employees, were arrested for stealing semaglutide from a Dr Reddy’s Laboratories warehouse. Semaglutide is the active ingredient in Novo’s Wegovy.

The police are investigating the theft of Ryzodeg, Fiasp and Wegovy. CDSCO has asked its employees to “keep a strict vigil on the movement” of the products and “initiate necessary action under the provisions of Drugs and Cosmetics Act, 1940 and Rules.”

CDSCO Notice

Philippine FDA responds to feedback on compassionate use of unauthorized products

The Philippine Food and Drug Administration has responded to feedback on plans to update guidelines on the compassionate use of unauthorized drugs, vaccines, and medical devices.

FDA shared the draft in January 2023, but only responded to the feedback last week. The draft guidelines covered the conditions under which qualified institutions and licensed physicians can apply for a permit to use a product on a compassionate-use basis. Other sections addressed the documents that applicants need to submit and post-approval commitments.

The agency has clarified, added, and deleted text in response to some of the feedback. FDA declined to make changes in response to other comments, such as a request for the agency to specify the process for renewing a permit for compassionate use.

FDA said it is not possible to include a renewal process because “all applications are evaluated independently based on the submitted requests and not dependent on previous submissions.” Applicants who successfully applied for a permit in the past can reapply, provided they have submitted their post-approval commitments, but must use the same pathway as people filing for the first time.

The agency said the turnaround time for initial applications is seven days, compared to 30 days under Philippine rare disease guidance. As such, “further shortening the already tight turnaround time for evaluation through inclusion of a renewal pathway appears to likely result in more risks than benefits,” the agency said.

FDA Notice

CDSCO sets March deadline for adding excipient details to drug packaging QR codes

CDSCO has given manufacturers until 1 March 2026 to update bar and QR codes on drug packaging with details of the excipients used in their products.

The Indian regulator proposed the change last year. At that time, CDSCO planned to add “details of excipients” to the list of information that manufacturers of some products must include in a bar or QR code on the primary packaging label (RELATED: Asia-Pacific Roundup, Regulatory Focus, 22 July 2024). In finalizing the proposal, CDSCO has changed the wording to “qualitative details of excipients” and set a deadline for compliance.

CDSCO’s finalization of the plan is the latest step for a reform that authorities have debated since 2023. Back then, India’s Drugs Consultative Committee considered complaints about drugs that used parabens as preservatives but lacked information about the excipients on the strips of medicines sold in shops. DCC said the situation causes inconvenience to patients who are allergic to the excipients.

Subsequent debates by DCC and the Drugs Technical Advisory Board (DTAB) identified challenges to including excipient information on medicine strips. DTAB agreed last year to add information to QR codes for the top 300 brands and suggested preparing a list of excipients that cause hypersensitivity.

CDSCO Notice

FDA posts warning about the circulation of counterfeit vaccines in the Philippines

The Philippine FDA has warned the public about the circulation of counterfeit vaccines that pose serious risks to health and safety.

FDA’s notice lacks details about the counterfeit vaccines that are circulating in the Philippines. Rather, the agency has focused on the need for the public to remain vigilant and take certain precautions when sourcing vaccines.

Patients should only receive vaccines from authorized healthcare providers and licensed facilities, FDA said. The agency is also advising people to always check vaccine packaging and labels for signs of tampering or irregularities and to be cautious of suspicious or unverified sources offering vaccines outside of official channels.

FDA is asking people who suspect a vaccine is counterfeit or who encounter suspicious activities related to vaccine distribution to file reports through its official hotlines and contact channels immediately.

FDA Notice

Other news

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has published its annual performance statistics. Medsafe noted another increase in changed medicine notifications, but said that applications received and approved were consistent with previous years. Medsafe Report

Asia-Pacific Roundup: Malaysia and Singapore start pilot to fast-track medtech launches

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