Asia-Pacific Roundup: TGA seeks feedback on planned adoption of 11 international scientific guidelines
The Therapeutic Goods Administration (TGA) has proposed adopting 11 international scientific guidelines for use in Australia.
TGA has already adopted about 370 international scientific guidelines as part of its policy of aligning its regulatory approaches to those of comparable international counterparts wherever possible. The library includes 23 international guidelines that TGA adopted last month based on the outcome of a consultation it ran between November 2025 and February 2026.
The latest batch of documents proposed for adoption includes the European Medicines Agency’s (EMA) recent reflection paper on biosimilar development. Through the paper, which EMA adopted in March, European regulators created a process for bringing biosimilars to market without running comparative efficacy studies. Showing comparability at an analytical level, with a limited clinical data package offering supporting evidence, could streamline biosimilar development without compromising efficacy or safety.
The reflection paper is one of nine EMA documents in the batch of international documents under consideration at TGA. Many of the other EMA documents address specific therapeutic areas and product classes.
TGA is considering adopting guidelines on developing drugs for diabetes and ulcerative colitis, as well as on clinical trials of recombinant and human plasma-derived factor VIII products used to treat hemophilia A. Another EMA guideline addresses how to show therapeutic equivalence for inhaled treatments of asthma and chronic obstructive pulmonary disease.
The remaining EMA guidelines cover flu vaccine submissions, the quality of inhaled and nasal medicines, assessing the immunogenicity of therapeutic proteins, and process validation for finished products.
TGA is also considering adopting two International Council for Harmonisation (ICH) documents. The ICH texts are harmonized guidelines on selective safety data collection in specific late-stage pre-approval or post-approval clinical trials and on technical specifications for clinical trial protocols.
The consultation closes on 11 September.
CDSCO cancels registration of 7 Indian ethics committees over failed inspections
The Central Drugs Standard Control Organization (CDSCO) has canceled the registration certificates of seven Indian ethics committees after performing risk-based inspections.
CDSCO inspects ethics committees to assess compliance with regulatory requirements and good clinical practice guidelines, as well as to evaluate the effectiveness of their quality management systems (QMS). The inspections are part of CDSCO’s efforts to ensure the protection of clinical trial participants’ rights, safety, well-being, and dignity.
Inspectors found “significant deficiencies and major non-compliances” with provisions of India’s New Drugs and Clinical Trials Rules, 2019, CDSCO said. Responding to the findings, CDSCO issued inspection reports and evaluated the ethics committees’ corrective and preventive action responses.
CDSCO gave the ethics committees opportunities to argue against further enforcement actions. Yet the agency concluded that the registration certificates needed canceling in light of inspection findings that negatively affected the ethics committees’ ability to meet responsibilities set by Indian legislation and guidelines. CDSCO cancelled the certificates between July 2025 and May 2026.
The agency advised all registered ethics committees to ensure strict compliance with the rules. CDSCO urged ethics committees to put particular emphasis on establishing and maintaining a robust QMS and ensuring their reviews are independent and transparent. Ethics committees must maintain complete and accurate records and effectively identify and manage conflicts of interest, CDSCO said.
NPRA updates guidance on drug manufacturing license applications in Malaysia
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated its guideline on applying for licenses to manufacture, import, and wholesale registered products.
The fourth edition of the guideline replaces a version published in March 2025. Changes in the updated guideline include a longer timeline for approving license applications. Previously, NPRA committed to approving applications within four working days. The new guideline gives NPRA 15 working days to issue licenses and stipulates that applicants must comply with good manufacturing and distribution practices.
Other changes include a revision of the circumstances in which companies must apply for a new license. The updated list of triggers for new license applications includes the relocation of a company’s premises. In that situation, the company must update their address in NPRA’s online QUEST System.
NPRA also added a line clarifying that it will not impose processing fees when government agencies apply for licenses. The agency’s fees for non-governmental manufacturers, importers, and wholesalers are unchanged from the earlier version of the guideline.
Indian committee again pushes back against jumps in GLP-1 dose escalation
An Indian expert committee has questioned the dose-escalation regimen in a late-phase trial of Eli Lilly’s oral GLP-1 drug.
Lilly met the committee to discuss a phase 3 protocol. The protocol number corresponds to a pediatric trial that is scheduled to start next month. The study will compare orforglipron, the oral GLP-1 medicine that Lilly sells as Foundayo, to dulaglutide in children with Type 2 diabetes. Lilly is working with eight trial sites in India, according to the ClinicalTrials.gov listing for the study.
The expert committee challenged aspects of Lilly’s protocol. Concerns included Lilly’s alleged failure to properly justify the rationale for raising the dose from 12 mg to 36 mg without an intermediate step, such as a 24-mg dose. The committee also asked Lilly to justify the use of dulaglutide as the comparator and to provide clinical data on changes in lean muscle mass and body composition.
Lilly received the feedback one week after the same committee questioned the dose-escalation rate for Novo Nordisk’s injectable GLP-1 drug semaglutide. Novo requested Indian approval of a 7.2-mg dose of the drug, which it sells in obesity as Wegovy. The committee requested more evidence, including data to justify the omission of intermediate doses between 2.4 mg and 7.2 mg.
TGA fines Cellife over alleged breach of child‑resistant packaging requirements
TGA has fined Cellife Health Care AU$19,800 ($13,900) for allegedly supplying a medicine without the required child-resistant packaging.
Australia’s therapeutic goods regulatory framework requires sponsors to provide certain classes of drugs, as well as some individual substances, in child-resistant packaging. The list of substances covered by the requirement reflects factors such as the toxicity of the compound and risk of harm if accidentally ingested by a child.
Cellife was fined over a medicine that contained a level of iron over the threshold at which child-resistant packaging is required. A lack of child-resistant packaging for medicines containing higher levels of iron raises the risk of serious harm, TGA said. Cellife paid TGA’s AU$19,800 infringement notice last month.
The shipment of iron-containing products without child-resistant packaging is an international concern. In April, Vitaquest recalled more than 350,000 units of iron-containing dietary supplements produced in the US over the absence of child-resistant packaging.
Other News:
TGA is seeking feedback on proposed changes to the Required Advisory Statements for Medicine Labels (RASML). Under the RASML, manufacturers must include advisory statements on the labels of some over-the-counter drugs and registered complementary medicines. TGA has proposed adding celecoxib, methenamine, and naratriptan to the RASML. The consultation closes on 4 September. TGA Notice
An Indian government agency has signed a memorandum of understanding with the Asia Pacific Medical Technology Association. The agreement provides a framework for collaborating on topics including regulatory and policy engagement. Indian officials framed the agreement as part of efforts to strengthen domestic manufacturing of medical devices. Press Release