Asia-Pacific Roundup: Australia’s TGA seeks feedback on sharing clinical trial information, ICH GCP proposals
Australia’s Therapeutic Goods Administration (TGA) is holding consultations on information sharing under clinical trial schemes and its proposed comments on an international guideline for good clinical practice (GCP).
TGA has proposed strengthening its ability to publish information on the oversight of clinical trials. The proposals are intended to support regulatory decision-making, collaboration between groups involved in clinical trials, and the transparency of regulatory activities. TGA is seeking feedback on how the proposals could impact organizations.
Currently, TGA can release information from GCP inspections to the responsible ethics committee and the approving authority. The agency is proposing to allow the release of information collected through clinical trial notification and approval processes, in response to requests for information, and via safety reporting. The proposals would allow the release of unsolicited information received by TGA.
Officials also want to expand the list of people and organizations that receive information from TGA. The expanded list includes the principal investigator, people conducting the research, and multiple Australian bodies, including the National Health and Medical Research Council (NHMRC).
TGA provided examples of the type of information it may release to the different stakeholders. For example, the agency may contact the NHMRC when it receives inquiries about the ethical conduct and integrity of a Human Research Ethics Committee.
The proposals include new purposes for releasing information. Today, TGA can only release therapeutic goods information to ensure that clinical trials are conducted in a safe and lawful manner. Under the proposals, the agency would be able to release information to protect public health, support regulatory cooperation, promote transparency, and for other purposes.
Another section of the proposals addresses GCP enforcement outcomes. TGA currently publishes annual reports of deidentified information on the number and types of inspections, the types of findings, and whether those findings have been resolved. The agency is proposing to routinely publish the names of inspected clinical trial sites, together with information on whether enforcement action was taken or not. TGA is not proposing to publish confidential or commercially sensitive information.
The proposals are intended to promote compliance with GCP requirements, enhance public confidence in clinical trial oversight, and support the protection of study participants. TGA would apply the new powers prospectively, limiting its reporting to GCP inspections completed after the new arrangements take effect. The agency is seeking feedback until 20 November.
TGA is running the consultation in parallel to a request for feedback on its proposed comments to Annex 2 of the International Council for Harmonisation’s (ICH) GCP guideline. The annex covers clinical trials that incorporate decentralized elements, pragmatic designs, or real-world data (RWD).
The agency commented on a section of the annex about consent and permission considerations for RWD, explaining that “broad consent refers to consent provided by a participant for extended and/or unspecified research.” TGA plans to adopt the consolidated ICH GCP E6(R3) guideline in January.
TGA Consultation, GCP Comments
India forms committee to examine regulatory framework for pharmaceutical marketing
India’s Department of Pharmaceuticals has formed a committee to examine the regulatory framework for drug marketing practices and to recommend measures to strengthen oversight.
The country introduced a voluntary, industry-led self-regulatory mechanism in 2015. The mechanism, which was updated in 2024, was intended to promote ethical pharmaceutical marketing and regulate interactions between drugmakers and healthcare professionals. Officials have since identified a need for stronger oversight, monitoring, and enforcement mechanisms to curb unethical practices.
A three-person committee will examine issues related to unethical pharmaceutical marketing practices and assess the effectiveness of existing mechanisms. The committee will suggest regulatory measures, changes to the legal framework, and other actions that support greater transparency, accountability, and compliance.
None of the committee members work in or represent the pharmaceutical industry. The committee will speak to affected stakeholders and consider their submissions as part of “the requisite consultative process.” Once it meets for the first time, the committee will have two months to speak to stakeholders and submit its recommendations to the department.
The assessment of the regulatory framework comes months after Eli Lilly reportedly paused an obesity awareness campaign in response to a notice by India's Central Drugs Standard Control Organization (CDSCO). In March, CDSCO stated that direct and indirect marketing of prescription drugs is banned in India. The agency reportedly wrote to Lilly around the same time, leading it to pause the campaign.
TGA starts consultation into excluding digital mental health tools from medtech rules
TGA is seeking feedback on whether to eliminate or modify a clause that excludes some digital mental health tools (DMHTs) from Australian medical device regulations.
In 2021, the agency exempted a subset of very low-risk DMHTs from the regulations to avoid duplicating requirements. TGA reviewed the regulation of medical software and artificial intelligence (AI) in 2024, generating evidence that the exclusion may no longer be appropriate, given the increasing complexity and risk profiles of the products.
Consumers generally expect products to have been independently checked to ensure that they are safe and effective, TGA said. That expectation is not met for excluded products because they are not subject to TGA oversight.
The agency is seeking feedback on whether to maintain the status quo, remove the exclusion, or modify the criteria to bring higher-risk DMHTs within regulatory oversight. Removing or modifying the exclusion could meet consumer expectations of oversight but would impose administrative and cost burdens on DMHT providers.
Modifying the criteria could align Australian regulation more closely with overseas practices, such as the US approach to “general wellness” products. However, developing criteria that are risk-based and sufficiently clear to distinguish which products do and do not need regulating is a challenge, TGA said.
If it removes or modifies the exclusion, TGA plans to give sponsors two years to adapt to the new rules. Sponsors would need to notify TGA of their intention to transition a DMHT that is already in supply to give the agency visibility into the market.
TGA is seeking feedback until 7 December.
India’s CDSCO orders staff to make enforcing excipient safety processes a top priority
CDSCO has ordered India’s regional regulatory officials to prioritize manufacturer compliance with rules on testing excipients, including propylene glycol, glycerol, and sorbitol.
Reports of deaths linked to contaminated cough syrups containing substandard excipients prompted the Drugs Controller General of India (DCGI) to write to state and regional regulators last month. DCGI told officials to ensure manufacturers test each batch or lot of the raw material and to only source excipients from reliable, approved vendors.
Last week, DCGI sent a second letter telling Indian state drug controllers to make compliance with the raw material rules a “top priority.” Regulators must ensure strict compliance at all manufacturing units within their jurisdictions, DCGI said.
DCGI sent another notice about the oversight of companies that supply pharmaceutical-grade, high-risk solvents. Regional regulators must ensure suppliers register on the Online National Drug Licensing System and upload batch-wise data to the portal. No batch of pharmaceutical-grade solvent should be distributed without details being uploaded.
Other News:
CDSCO has updated the Drugs Rules, 1945, with information on the shelf-life requirements for imported biologics and radiopharmaceuticals. Imported products must have at least 60% of the labeled shelf-life period. Gazette Notification
