Asia-Pacific Roundup: Singapore’s HSA forges regulatory alliances across Africa, Asia, and Europe
Singapore’s Health Sciences Authority (HSA) has expanded regulatory reliance and cooperation activities with partners in Africa, Asia, and Europe.
HSA unveiled new agreements with the African Medicines Agency (AMA) and the Saudi Food and Drug Authority (SFDA). The memorandum of understanding (MOU) with SFDA supports the exchange of expertise, information, and best practices on pre-market and post-market matters. HSA and its Saudi counterpart will explore facilitative regulatory pathways for conventional and novel products, including those involving biotechnology and artificial intelligence.
The MOU with AMA establishes a framework for exchanging regulatory information, collaborating on regulatory science and practices, capacity building, and technical review. AMA will explore the use of HSA’s approvals and assessments as references.
Efforts to use HSA assessments in reliance programs are more advanced in Malaysia. Starting this month, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) is piloting the use of HSA’s medicine assessments in its reviews. NPRA will assess how regulatory reliance can reduce duplicated assessment work and support more timely access to medicines. If the pilot succeeds, HSA could become a reference agency for NPRA.
“A medicine or medical device should not have to wait because trusted regulators are repeating the same high-quality work,” HSA CEO Raymond Chua said. “By enabling partners to draw on HSA’s assessments, we can reduce duplication, support more timely access to safe and effective health products, and help innovators reach patients across more markets.”
HSA disclosed the partnerships alongside details of deepening collaboration with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). MHRA and HSA reaffirmed their commitment to the Regulatory Innovation Corridor, a program they launched in December to give developers of first-in-class medicines and frontier technologies early, iterative access to both regulators. The initiative is designed to help companies align earlier on evidence expectations, clinical trial design, and regulatory pathways.
Separately, the European Directorate for the Quality of Medicines and HealthCare (EDQM) extended Singapore’s associate membership of the General European Official Medicines Control Laboratory Network (GEON). The revised membership covers HSA’s National Biologics Testing Laboratory. Singapore’s Pharmaceutical Laboratory has participated in GEON since 2014.
EDQM extended the membership after a successful mutual joint audit. The extension recognizes that the laboratory meets the quality requirements and principles of the GEON, positioning Singapore to participate in work on complex biological medicines.
India issues advisory on stem cell therapy regulation in light of court ruling
India’s Ministry of Health and Family Welfare has published an advisory on when stem cell therapy is permitted as standard care in routine clinical practice.
The ministry published the advisory in response to a judgment from India’s Supreme Court. The court ruled that healthcare providers cannot offer stem cell therapy as a routine commercial treatment for autism spectrum disorder (ASD). Stem cell therapies can only be used to treat ASD within the regulatory framework for clinical trials.
Through the advisory, the ministry reiterated the existing framework governing stem cell research and therapy and shared the court’s ASD ruling. Stem cell therapy is permitted as standard care in routine clinical practice in a specified set of indications.
The court ruled that there must be consequences for noncompliance with the stem cell rules. Findings of professional misconduct, cancellations of clinical establishment registration, and penalties were among the consequences proposed by the court. In response, the ministry told state and district regulatory authorities to ensure strict compliance with the framework for stem cell research and therapy.
The ministry published its response to the court ruling shortly after India’s National Medical Commission (NMC) shared an advisory on the topic. NMC’s advisory focused on the implications of the court ruling for healthcare professionals, medical institutions, and state medical councils.
Australia’s TGA tests fake retatrutide after case of ‘uncontrollable vomiting’
Australia’s Therapeutic Goods Administration (TGA) is testing counterfeit retatrutide after a consumer was hospitalized following consumption of a fake product.
Eli Lilly is developing retatrutide but has yet to win approval. The investigational peptide engages three targets, including GLP-1, and has driven deep weight loss in clinical trials. In recent months, regulatory agencies, including TGA and the New Zealand Medicines and Medical Devices Safety Authority, have acted to stop counterfeit retatrutide from reaching patients.
Last week, TGA reported that a person experienced uncontrollable vomiting after consuming counterfeit retatrutide. The vomiting resulted in a torn esophagus and required treatment in hospital.
TGA testing of the counterfeit retatrutide showed the product contained undeclared semaglutide, the GLP-1 receptor agonist that Novo Nordisk sells as Ozempic and Wegovy. The counterfeit contained no retatrutide.
“The biggest risks with unapproved peptide products are not knowing what is in the vial, how much of or even what substance it contains, whether it is sterile, or whether it contains other contaminants or toxins,” Robyn Langham, TGA’s chief medical adviser, said. “These risks are particularly concerning for injectable products.”
Semaglutide levels were about eight times above the amount found in official products registered in Australia. The highest Wegovy dose approved in Australia is 2.4 mg, although a 7.2-mg dose is available in some markets.
Indian board recommends halving timeline for study drug import licenses
India’s Drugs Technical Advisory Board (DTAB) has recommended cutting the timeline for issuing study drug import licenses from 90 to 45 working days.
Minutes published last week show DTAB, which advises the Indian government, discussed the timeline for issuing Form CT-17 licenses at a meeting late last month. The proposed 45-day timeline is in line with the New Drugs and Clinical Trials (Amendment) Rules, 2026, which India’s Ministry of Health and Family Welfare published in January.
DTAB discussed Form CT-17 timelines while assessing a proposal to expand use of the “prior intimation” pathway. The pathway, which officials created in January, allows applicants to start making study drugs once they receive an acknowledgment, rather than waiting for full permission.
If DTAB’s interpretation takes effect, the pathway will apply to imports of new drugs for analytical and non-clinical testing, with exceptions for modalities including cell and gene therapies. DTAB debated whether to apply the pathway to imports of drugs for clinical trials and bioavailability or bioequivalence studies.
The rulings on prior intimation and CT-17 timelines were some of many positions DTAB reached at the meeting. The board also addressed oversight of sterile injectables and good manufacturing practices for study drugs. Other rulings related to the medtech industry. DTAB proposed a definition of “in vitro diagnostic” while addressing test license exemptions and post-marketing clinical investigations.
Malaysia strengthens drug, device cooperation partnership with UK MHRA
Malaysia’s Ministry of Health and the UK MHRA have agreed on practical next steps for advancing their regulatory partnership.
Further engagement between experts and opportunities for teams to work together are planned as the two sides work to tighten their ties. Leaders from Malaysia and the UK outlined the next steps after a recent meeting, at which they discussed opportunities to work more closely on medicines, medical devices, and clinical trials.
“Areas of potential collaboration include greater expert exchange, sharing regulatory knowledge and best practices, advancing work on emerging technologies, and exploring more efficient development and approval pathways while maintaining high standards of safety, quality, and effectiveness,” MHRA said.
