Asia-Pacific Roundup: Compliance issues drive TGA to float changes to charge exemption scheme

Australia’s Therapeutic Goods Administration (TGA) has proposed changes to the compliance program for its charge exemption scheme to address an increase in issues with the initiative.

The scheme exempts companies from annual charges for medicines and medical devices in the Australian Register of Therapeutic Goods (ARTG) until the products begin generating revenue. Australia offers the exemption to allow companies to enter their products in the ARTG before marketing without incurring charges. There is no time limit on exemptions, which remain in place until sales are generated.

Sponsors renew exemptions by annually self-declaring zero turnover. TGA estimated that the total value of revenue foregone due to exempt entries in 2025-26 is AU$56.5 million ($40.2 million). The agency runs a program to verify the accuracy of self-declarations by reviewing sponsor records. However, TGA said the program is increasingly unable to verify the turnover status of entries because the information is incomplete.

According to TGA, common explanations for gaps in the information include the lack of accurate historical records prior to integration into sponsor sales systems and “corporate memory loss.” Memory loss is linked to issues such as inconsistent record-keeping following transfers of sponsorship between entities. Sponsors are often unable to show that a product had zero turnover before they took over its ARTG entry.

TGA also noted an increase in the number of sponsors that do not reply to its requests. Most sponsors continue to engage with compliance reviews, TGA said, but the uptick in companies that ignore requests is impeding the agency’s ability to confirm eligibility for exemptions. TGA cannot compel sponsors to reply, leading to incorrectly or falsely claimed exemptions that compliant sponsors effectively subsidize.

“Establishing powers to cancel exemptions when turnover status cannot be verified will help ensure a more equitable environment among sponsoring organizations,” TGA said. “Additionally, these measures will reduce forgone revenue stemming from inadvertently incorrect or deliberately false declarations.”

TGA’s preferred solution is to amend the regulations to ensure products qualify for the exemption only when the sponsor provides evidence of AU$0 turnover or has responded to a compliance notice. The changes would empower officials to revoke exemptions.

TGA said the ability to cancel exemptions and apply annual charges should incentivize greater cooperation and transparency among sponsors.

The agency is seeking feedback until 20 March.

TGA Consultation

Malaysia’s MDA finalizes guidance supporting e-labels for home-use medical devices

Malaysia’s Medical Device Authority (MDA) has finalized the seventh edition of its guidance on medical device labeling, enshrining changes to e-labels that it released for consultation in October.

Previously, manufacturers could only provide electronic instructions for use for products intended for use by professionals.

MDA proposed extending the option to home-use devices in draft guidance last year. The agency has tweaked the wording supporting e-labels for home-use devices in the final guidance but retained the draft’s intent.

Other changes between the draft and final documents include adding a line about the addition of labels with translations or details of the authorized representative or importer. MDA permits the use of such labels, provided they do not obscure certain important existing information and remain legible throughout the device’s shelf life.

Elsewhere in the guidance, MDA has revised information on the need for authorized representatives, importers, and foreign manufacturers to provide details, such as their address for technical assistance.

MDA Notice

TGA publishes guidance on its legal powers to order recalls and other market actions

TGA has shared guidance on legal powers related to recalls and other market actions, such as its ability to make sponsors withdraw products if they decline to act voluntarily.

The Australian government rewrote the rules on recalls, product alerts, and product corrections last year, and TGA created the guidance to support the recall reforms.

While sponsors typically recall products on their own accord or after a recommendation from TGA, they occasionally decline to recall products. Australian law, however, allows TGA to force uncooperative sponsors to recall products.

In the guidance, TGA explains that the law requires sponsors to comply with recall orders “within such reasonable period as is specified.” The agency said the period deemed reasonable depends on the severity and likelihood of harm to patients. People who fail to comply can be imprisoned for up to five years and the law also supports civil penalties.

TGA published the guidance alongside frequently asked questions about the procedure for recalls, product alerts, and product corrections that took effect last year. The questions cover topics such as the need to comply with the procedure, the timeframe for reporting actions to TGA, and the information to include in risk assessments.

TGA Notice

India’s CDSCO automates clearance of drug testing requests to accelerate processes

The Central Drugs Standard Control Organization (CDSCO) is moving to automatic clearance of requests to test drugs at certain Indian laboratories to accelerate requests for approval.

CDSCO’s changes, which will take effect on 1 June, apply to requests to import or manufacture drugs. Currently, the agency assesses information, including critical quality attributes, product development reports, and compliance with relevant monographs before issuing a no objection certificate (NOC). Drug testing at designated laboratories is a prerequisite for approval.

Under the new system, CDSCO will immediately issue an NOC for testing drug samples at designated laboratories upon receiving an application. It expects companies to submit their finalized regulatory specifications based on pharmacopeial standards and the product-specific quality management system. The changes are intended to reduce approval timelines.

If specifications are changed after review or feedback from CDSCO, the regulator will issue a new NOC for retesting at the designated laboratory. The retesting will follow the revised specifications.

CDSCO Notice

Malaysia’s NPRA posts appendices to guideline on good clinical practice inspections

The National Pharmaceutical Regulatory Agency (NPRA) has published supplementary guidance on good clinical practice (GCP) inspections.

The first section of the document explains how NPRA inspectors classify GCP compliance issues by listing examples of critical, major, and minor findings. Examples of critical findings include fabricating study data, importing an investigational product without license or exemption, and severe validation failures in electronic data capture systems.

The second half of the document describes areas of focus during NPRA inspections of investigator sites, computerized systems, and sponsors and contract research organizations (CROs). Across all inspections, NPRA has emphasized the importance of traceability and oversight, such as when a sponsor delegates tasks to a CRO or an investigator uses an electronic health record system.

NPRA Guidance

Other News:

Indian and Brazilian regulators have exchanged a memorandum of understanding (MoU) to strengthen cooperation on pharmaceutical regulation. CDSCO exchanged the MoU with Brazil’s Health Regulatory Agency (ANVISA) and said the document establishes a structured framework for cooperation and exchange of information between the regulators and promotes regulatory convergence. Press Release

The Department of Drugs Control, Government of Puducherry, has issued a warning about unauthorized copies of the Indian Pharmacopoeia (IP). Authorities published the notice after finding that sales trends for the IP and associated reference and impurity standards do not match the number of manufacturers and testing labs in India. Authorities warned that it is illegal to use unauthorized copies. Government Circular

TGA has extended measures to mitigate a shortage of Alphapharm’s statin Zimstat. The agency decided to keep the measures in place until 31 May after Alphapharm extended the shortage to the end of April. TGA Notice

Asia-Pacific Roundup: Compliance issues drive TGA to float changes to charge exemption scheme

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