Asia-Pacific Roundup: Malaysia accepts FDA medtech approvals under reciprocal trade agreement
Malaysia’s Medical Device Authority (MDA) has welcomed a trade agreement with the US that has implications for medtech approvals.The US and Malaysian governments agreed to a reciprocal trade deal last week. While the terms of the agreement extend beyond life sciences, the trade deal has specific implications for developers of medical devices. The implications stem from the inclusion of an agreement on non-tariff barriers to trade in the deal.
Under the terms of the deal, Malaysia will “allow US originating goods that comply with applicable US or international standards, US technical regulations, or US or international conformity assessment procedures to enter its territory without additional conformity assessment requirements.”
The commitment requires Malaysia to accord US conformity assessment bodies “treatment no less favorable than that it accords to its own bodies.” Malaysia has also agreed to “facilitate the acceptance of US compliance procedures for goods that are not subject to third-party conformity assessment in the US regulatory framework.”
US officials have secured the commitments to prevent technical regulations, standards, and conformity assessment procedures from acting as disguised restrictions on bilateral trade. Malaysia has agreed to remove existing technical barriers to trade in areas that “undermine reciprocity, including requirements for duplicative or unnecessary testing or conformity assessment.”
MDA explained the implications of the deal for medical device developers in a statement. Pointing to a technical footnote to the deal, MDA said Malaysia can maintain its registration requirements for medical devices.
Malaysia’s acceptance of Food and Drug Administration approvals does not mean devices authorized in the US will gain automatic entry to the market, MDA said. Rather, the agency will rely on US paperwork to avoid duplication of conformity assessments while continuing to register devices to ensure they meet local regulations and safety and quality requirements.
The deal retains the existing 19% tariff on medical devices but grants exemptions to products in three more categories: certain products that contain antigens or antisera, gels used as medical lubricants, and some disinfectants. MDA said the measures support industry competitiveness and access to advanced healthcare technologies.
Malaysia has accepted the requirements to become a member of the International Medical Device Regulators Forum and Medical Device Single Audit Program, MDA said. The country has been a member of both initiatives since February.
MDA Notice, Trade Deal
India advances probe into alleged dumping of Chinese tuberculosis drugs
The Directorate General of Trade Remedies (DGTR) has advanced a probe into claims that Chinese and Thai manufacturers have dumped products on the Indian market at unfairly low prices.
Lupin, an Indian drugmaker, triggered the probe into the tuberculosis drug ethambutol hydrochloride. The company provided evidence that ethambutol imports that undercut the domestic industry have hurt the profitability of local manufacturers. According to the filing, Lupin is the only Indian manufacturer of the drug. Lupin said Cadila Pharmaceuticals imports the drug from China and Thailand.
DGTR formally began its investigation in September. Last week, the organization advanced to the next stage of the probe by publishing a list of interested parties. The interested parties are Lupin and Wuhan Wuyao Pharmaceuticals, a Chinese manufacturer and distributor of pharmaceutical ingredients. Wuyao’s website lists ethambutol hydrochloride as one of the ingredients that the company supplies.
Lupin and Wuyao are on the list because they registered themselves as interested parties after DGTR opened its investigation. DGTR has asked the companies to forward non-confidential versions of their submissions to each other. The interested parties should include each other on future non-confidential submissions to DGTR.
The directorate has asked the interested parties to file a questionnaire by 7 November. DGTR made the request in an update on the methodology for the investigation, which the directorate finalized after no interested parties commented on the scope of the product under consideration.
DGTR List, More
New Zealand expands use of GSK’s RSV vaccine, limits vaccinator eligibility
New Zealand’s Medicines Classification Committee (MCC) has extended the use of GSK’s respiratory syncytial virus (RSV) vaccine to younger adults.
GSK asked MCC to reclassify its vaccine to allow use in people ages 50 to 59 who are at increased risk of RSV disease. MCC agreed to allow the use of GSK’s vaccine in people who meet the age and risk criteria but imposed restrictions on who can administer the shot. Only registered pharmacists, a subset of all authorized vaccinators, can administer the shot to people ages 50 to 59.
MCC’s changes diverge from GSK’s proposal, which would have allowed “registered pharmacists and/or authorized vaccinator” to administer the shot. The committee said it decided to limit use to pharmacists in light of “outstanding concerns around this being extended to all authorized vaccinators.”
The concerns include doubts about whether all authorized vaccinators could evaluate whether someone is at increased risk for RSV disease. GSK’s submission lacked a training plan and implementation protocol, MCC said, and as such it is unclear how all authorized vaccinators would identify whether administration of the vaccine is appropriate.
Officials placed restrictions on administering the vaccine despite receiving positive feedback on GSK’s proposal. The Pharmacy Guild of New Zealand strongly urged MCC to support vaccination of the population by pharmacist vaccinators and other authorized vaccinators. The Pharmaceutical Society of New Zealand also backed the reclassification without commenting on vaccinators.
Meeting Minutes, Feedback
India’s CDSCO adds cell and gene therapy features to online filing portal
CDSCO has updated Sugam to enable cell and gene therapy developers to use the online portal to file post-approval changes to their clinical trials in India.
The Indian regulator adapted Sugam earlier this year to enable sponsors to file to run Phase I, II, and III clinical trials of cell and gene therapies. With the ability to make initial applications in place, CDSCO began work to update Sugam to handle post-approval changes for cell and gene therapy studies.
CDSCO’s launch of the feature allows cell and gene therapy developers to use Sugam to seek permission for a change or to notify the regulatory agency of a revision to a study. The agency has created a user manual and video tutorial to help companies use Sugam for post-approval changes.
Sugam is now the only accepted route for making cell and gene therapy clinical trial applications. CDSCO stopped accepting offline submissions days before sharing details of the expansion of Sugam to support post-approval changes.
CDSCO Notice
Hong Kong officials post alert about unproven cervical screening methods
The Hong Kong Department of Health has warned against using cervical screening methods that lack sufficient scientific evidence.
Officials published the alert in response to claims by businesses that menstrual blood can be collected using sanitary pads, then self-sampled and mailed to laboratory for human papillomavirus (HPV) testing. Hong Kong adopted HPV testing as the primary approach of cervical screening in women aged 30 to 64 years in 2023.
However, the tests recommended in Hong Kong use cervical cells, not menstrual blood. Officials said there is insufficient scientific evidence of the feasibility and reliability of HPV tests that use self-collected menstrual blood or urine samples.
Press Release
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