Asia-Pacific Roundup: Malaysia’s MDA joins MDSAP as affiliate member

The Medical Device Authority (MDA) will begin accepting Medical Device Single Audit Program (MDSAP) reports and certificates to support regulatory submissions in Malaysia.

Through MDSAP, a recognized auditing organization can conduct a single assessment of a medical device manufacturer that satisfies the relevant requirements of multiple participating regulatory authorities. MDSAP’s Regulatory Authority Council (RAC) recently named MDA as an affiliate member, positioning the Malaysian regulator to start accepting reports and certificates produced as part of the program.

Malaysian officials said MDA’s recognition as an affiliate member “marks a new era of global trust, faster approvals, and greater access to safe, innovative medical technologies.” The agency framed the event as a “significant achievement” in its attempt to become a globally trusted regulatory authority.

MDA will accept MDSAP documents to support regulatory submissions for establishment licensing and medical device registration as evidence of compliance with quality management system (QMS) requirements. Local manufacturers can include the files in establishment license applications, in lieu of ISO 13485 certification, provided the conformity assessment body and auditor are registered with MDA.

The paperwork can also support medical device registration filings from local and foreign manufacturers. Local companies can use MDSAP reports and certificates under the same conditions as for establishment license applications. Foreign manufacturers can use documents issued by an MDSAP-recognized auditing organization as evidence of QMS compliance for the purpose of medical device registration in Malaysia.

MDA joins regulators from Korea, Taiwan and countries outside of Asia on the list of affiliate members. RAC grants the status to regulators that engage in MDSAP, show an understanding of the program, and use its audit reports and certificates to evaluate compliance with medical device requirements.

MDA Notice, More

Amid delays, India’s CDSCO sets timelines for handling requests to information

India’s Central Drugs Standard Control Organization (CDSCO) has set deadlines for handling each step in the request to information (RTI) process to prevent delays.

Under Indian legislation, government departments have up to 45 days to process appeals in RTI cases. CDSCO said it has seen several appeals that are pending beyond that deadline in “some divisions.” The agency named three appeal cases that have been delayed, adding that it has seen instances of officials failing to address RTI applications within the stipulated timeframe.

Seeking to ensure strict compliance with the legislation, CDSCO has set deadlines for various steps in the RTI process. Appeal replies should be submitted within two days or within seven days, depending on whether the original RTI application was handled by multiple divisions or a single division. CDSCO has provided similar targets for different types of initial applications and for later steps in the appeal process.

The agency has asked all divisions and officers to ensure strict compliance with its instructions to avoid delays and ensure the smooth functioning of the RTI system. There are penalties for failing to achieve the timelines.

“In case the reply is not submitted within the stipulated period and any penalty is imposed by the Central Information Commission, the responsibility for the same shall rest with the concerned DPIO/Division Head, as per the provisions of the RTI Act,” CDSCO said.

CDSCO Notice

Australia's TGA says GMP clearance actions are reducing backlog at the expected rate

Australia’s Therapeutic Goods Administration (TGA) has provided an update on the status of its attempt to reduce its backlog of good manufacturing practice (GMP) clearance applications.

TGA moved to reduce the backlog at the start of July. The agency automatically extended existing mutual recognition agreement and non-sterile active pharmaceutical ingredient compliance verification GMP clearances that were due to expire between 1 July 2025 and 30 June 2027. Officials also abbreviated the evaluation of sites performing certain lower-risk activities and ended pandemic-era flexibilities.

Last week, TGA said it has implemented all the strategies, and the backlog is reducing at the expected rate. The agency extended more than 6,200 GMP clearances over the first 10 days of July. Subsequently, TGA found 887 correlating applications in its lodgement system, 430 of which were no longer required and were closed. TGA will process the remaining applications over the coming months.

Abbreviated evaluations will continue throughout the reduction of the backlog, TGA said, and the ending of pandemic-era flexibilities has not caused major issues with evidence availability. The agency has stopped accepting the GMP clearance questionnaire as a form of application evidence but said the availability of reports from global GMP inspections has minimized the impact of the change.

TGA will continue to monitor the effectiveness of its initiatives and provide progress updates.

TGA Notice

Pakistan’s DRAP launches mandatory online portal for biological lot release certificates

The Drug Regulatory Authority of Pakistan (DRAP) has launched an online portal to process lot release submissions for biologicals.

DRAP will use the portal to receive applications and issue lot release certificates. The agency framed the move to an online portal as part of an “ongoing digitization drive to enhance efficiency, transparency, and public service delivery.” DRAP set out the potential benefits of the portal.

“This initiative is a significant step towards the complete digitalization of regulatory processes, aiming to streamline the submission, review, and approval of lot release applications,” DRAP said. “The new system will ensure a more efficient and expeditious regulatory oversight, safeguarding public health and facilitating trade in a less paper environment.”

DRAP wants importers and manufacturers of human vaccines, plasma-derived products, and anti-sera to submit all future lot release applications through the online portal. The directive is scheduled to come into force on 1 October. DRAP has advised affected organizations to familiarize themselves with the new online submission process to ensure a smooth transition.

DRAP Notice

TGA approves Leqembi for Alzheimer’s after Eisai appeal

TGA has approved Eisai’s Alzheimer’s disease drug Leqembi. The Australian regulator rejected a filing for approval one year ago but changed its position on appeal.

Officials originally found the reduction in disease progression compared to placebo was not significant enough to provide a meaningful clinical benefit or to outweigh the associated safety risks. The decision was upheld on appeal, prompting Eisai to ask the Administrative Review Tribunal (ART) to review TGA’s decision.

TGA said Eisai provided new risk management proposals and updated product information during the ART process. The submissions focused on safety in APOE4 heterozygous carriers and were designed to address outstanding safety concerns. Eisai shared an 18-month review of cognitive function and clinical symptom assessment to determine if the patient had progressed to moderate Alzheimer’s dementia.

Because the submissions addressed the safety concerns, the ART sent the matter back to TGA earlier this month. TGA approved the medicine for use in adults with early Alzheimer’s who are APOE4 non-carriers or heterozygotes. Physicians should use a validated beta amyloid test before prescribing the drug.

TGA Notice

Other News:

TGA’s investigation into the effectiveness, quality, and safety of Vyvanse found no issues of concern. The agency began looking into Vyvanse, which Takeda sells for use in attention deficit hyperactivity disorder, in response to an unexpected increase in adverse event reports. TGA linked the increase to social media commentary. All batches tested were compliant with expected strengths and quality. TGA Notice

Asia-Pacific Roundup: Malaysia’s MDA joins MDSAP as affiliate member

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