Asia-Pacific Roundup: India’s CDSCO halves clinical trial review timelines

India’s Central Drugs Standard Control Organization (CDSCO) is halving turnaround times for some clinical trial submissions as part of a raft of reforms to the regulation of drug development. The New Drugs and Clinical Trials (Amendment) Rules, 2026 update the original 2019 legislation.

Based on the draft shared for consultation in August, the revised rules will reduce the amount of time CDSCO has to review requests to make new drugs, investigational new drugs, or unapproved active pharmaceutical ingredients for trials, bioavailability or bioequivalence studies, and examinations, tests, and analyses. CDSCO will have 45 working days, compared to 90 days under the 2019 legislation.

The new rules, which will come into force 45 days after publication, create a “prior intimation” route for certain types of studies. Rather than waiting for full permission, applicants eligible for the route can start making study materials once they receive an acknowledgement.

CDSCO has excluded certain high-risk categories from the fast track. Companies must continue waiting for permission to make sex hormones, cytotoxic molecules, beta lactam antibiotics, biologics with live microorganisms, narcotics, and psychotropic drugs.

The agency has updated its application forms, appeals process, and rules regarding validity, suspension, and cancellation to reflect the prior intimation route. Companies cannot sell products made under prior intimation. The clearance to make the drugs only covers their use in studies. Any unused, damaged, or expired stock made under the rules must be destroyed and the action recorded.

CDSCO moved ahead with revisions to the legislation after the Drugs Technical Advisory Board (DTAB) supported its plans to streamline the process for seeking permission to make drugs for human studies. The switch to prior intimation, which DTAB called a notification system, for certain classes of medicine and the reduction in review times were agreed at a meeting in 2025.

Revised Legislation

TGA puts proactive, risk-based enforcement at center of Australia’s compliance agenda

The Therapeutic Goods Administration (TGA) has published its compliance principles for the next two years, setting out how it will monitor and enforce rules on the import, export, manufacture, supply, and advertising of medicines and medical devices in Australia.

After reviewing the priorities it set for 2023-2025, TGA realigned its approach to focus on five core compliance principles. The five principles are to safeguard therapeutic goods, educate to empower, protect those most at risk, leverage digital capability, and strengthen enforcement.

TGA’s approach to safeguarding therapeutic goods centers on proactive scrutiny of advertising, especially in digital spaces, and the disruption of unapproved and falsified goods sold via e-commerce platforms and social media. Countering misinformation and disinformation, particularly online, including via social media and influencer content, is a fundamental part of TGA’s educate-to-empower principle.

The agency plans to use digital capabilities to counter the online threats, including by modernizing its compliance tools to better monitor the internet. Addressing risks from AI-generated misinformation and deceptive endorsements is another part of TGA’s digital principle, although the agency is yet to expand on how it will achieve that goal.

As part of its principle of strengthening enforcement, TGA plans to target non-compliance via digital channels, including influencers and online marketplaces, and raise the visibility of compliance actions. By taking swift, proportionate action and responding to emerging trends, TGA aims to ensure accountability and reinforce public confidence.

TGA is applying the principles to 12 key areas, including direct-to-consumer in vitro diagnostics, software as a medical device, substandard and falsified therapeutic goods, and weight-loss drugs. The agency will review its priority areas quarterly, starting 31 March, and update them as required. TGA plans “intelligence-led and risk-based reviews of emerging or continued risks to public health and safety.”

The agency will review the broader compliance principles and program in late 2027.

TGA Notice

Japan’s PMDA shares advice on replacing conventional virus tests with sequencing assays

The Pharmaceuticals and Medical Devices Agency (PMDA) has published guidance on replacing standard virus tests with next-generation sequencing (NGS) assays in Japan.

Technologies such as nucleic acid amplification and antibody production tests enable drug developers and marketing authorization holders to test for viruses. Such testing is needed because of the potential for adventitious viruses to contaminate human or animal cells, compromising the safety of biologic drugs made using the materials.

PMDA discussed the prospect of NGS assays replacing existing tests in an early consideration document. The use of NGS assays in virus detection was initially limited by factors such as cost, PMDA said, but recent advances have made the technology viable. The International Council for Harmonisation reflected the emerging practicality of NGS assays in an update to its viral safety guidance last year.

Responding to the shifts, PMDA has provided advice on validating analytical procedures for NGS assays and replacing conventional tests. The validation section covers selecting reference viruses, specimens, NGS technology platforms, and database and informatics analysis software. PMDA’s advice on replacing conventional tests addresses the specific considerations of switching from a range of established technologies to NGS assays.

The agency said companies considering moving from antibody production tests to NGS assays do not need to perform head-to-head comparisons because the platforms are fundamentally different. Rather, PMDA said developers should collect information to show that the NGS assay is capable of detecting the specific viruses of concern with sufficient sensitivity to meet the expected performance criteria.

Discussing in vitro tests, PMDA said it is premature to use NGS assays instead of the established method of virus detection. The agency will judge on a case-by-case basis whether NGS assays can be used with in vitro tests as part of an integrated virus safety strategy throughout the manufacturing process. PMDA is encouraging companies considering an integrated approach to consider talking to its applicable office.

PMDA Guidance

CDSCO readies final rejections of stalled applications filed via India’s online Sugam portal

CDSCO is preparing to reject applications that have been pending in its Sugam portal for more than two years to clear stalled submissions from the system.

The Indian regulator’s divisions for new drugs, medical devices, and other areas use the portal to process applications. Sugam features a reminder mechanism that allows CDSCO to contact applicants that are yet to respond to queries raised during the review process. After sending the first reminder, CDSCO sends two more notices 30 days apart. The agency sends a disposal notice 30 days after the second reminder.

Despite CDSCO having a timeline for sending disposal notices, some applications have been pending for more than two years. The agency recently published a notice about the long-pending filings, warning applicants that it will reject the submissions in 30 days. Affected applicants, which have already received three reminders, will get a final rejection communication and forfeit their fees.

Companies can avoid that outcome by resolving pending queries within the specific time period. CDSCO sent the notice January 16.

CDSCO Notice

Other News:

TGA has extended its serious scarcity substitution instrument (SSSI) for hormone replacement therapy patches containing estradiol. The Australian regulator took the action after learning that shortages of the products will continue throughout 2026. Under the extended SSSI, pharmacists can dispense an alternative brand or strength of patches without a new prescription through February 2027. TGA Notice

Asia-Pacific Roundup: India’s CDSCO halves clinical trial review timelines

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