Pharma – Asia, S America, MENA, ROW Regulatory News – Sept 2025

AUSTRALIA

TGA Updates Permissible Ingredients for Listed Medicines

Australia’s Therapeutic Goods Administration (TGA) has released Determination No. 3 of 2025, effective 19 September. This update replaces Determination No. 2 and includes changes to 53 listed medicine ingredients. New additions include Crithmum Maritimum, Pediococcus Pentosaceus, and Urolithin A. One ingredient Crithmum Maritimum Whole Plant Extract has been removed. Multiple substances were revised, including Glucosamine Sulfate, Benzyl Benzoate, and Curcuma species.

TGA Clarifies POTAS1 Label Warning for Potassium Ingredients

The TGA has corrected discrepancies in the Code Tables for potassium-related label warnings. Medicines with potassium chloride or glucosamine sulfate potassium chloride now require the ‘POTAS1’ code. The updated warning aligns with TGO 92 and excludes the outdated “Contains potassium” statement. A second warning, ‘POTAS2’, addresses health risks for patients with kidney or heart conditions. Sponsors must review ARTG entries and ensure label compliance with current standards. Corrections can be submitted anytime via the General Listed application on TGA Business Services.

TGA Reaffirms Safety of Paracetamol Use in Pregnancy

Australia’s TGA and Chief Medical Officer reject claims linking paracetamol use in pregnancy to ADHD or autism. Robust studies show no causal link, supporting paracetamol as the recommended treatment for pain and fever. Untreated symptoms may pose risks to unborn babies, reinforcing the need for safe symptom management. Paracetamol remains a Category A medicine—safe when used as directed during pregnancy. TGA continues rigorous safety monitoring and collaborates with global regulators on emerging evidence. Pregnant individuals should consult healthcare professionals before taking any medication.

TGA Issues Advertising Direction to Cholrem Pty Ltd

The TGA has directed Cholrem Pty Ltd and Mr. Kyle Hodgetts to cease misleading advertising of unregistered medicines. Promotional claims for Cavadex and Remchol violated multiple sections of the Therapeutic Goods Act 1989. The products were falsely represented as approved by government authorities and linked to serious conditions. All related audiovisual content and websites must be taken down immediately. Cavadex is not registered in the ARTG and has never been assessed for safety or efficacy by the TGA. Consumers are urged to seek medical advice and avoid unverified therapeutic claims.

BRAZIL

NDS Web System Update Scheduled by Anvisa

Anvisa announces a new version of the NDS Web application for controlled product authorizations. The system will be unavailable on Tuesday, September 23, from 8:00 AM to 6:00 PM. Import and export petitions, including quota codes, will be paused during integration. The update enhances tracking of psychoactive drugs and chemical precursors. NDS was developed by UNODC to support national and international drug control. Access the updated system manual.

CHINA

China and Singapore Strengthen Regulatory Ties in Drug and Medical Device Oversight

On September 10, Li Li, Commissioner of China’s National Medical Products Administration (NMPA), met with Raymond Chua Swee Boon, CEO of Singapore’s Health Sciences Authority (HSA), to advance bilateral cooperation in pharmaceutical and medical device regulation. The meeting highlighted China’s ongoing reforms to enhance drug safety, review systems, and regulatory capacity, while Singapore shared its global harmonization efforts and reliance mechanisms. Both sides discussed mutual recognition strategies and traditional Chinese medicine oversight. The dialogue concluded with a commitment to deepen collaboration and improve regulatory quality for public health benefit.

Mainland-Hong Kong Deepen Drug Regulatory Cooperation

On September 4, NMPA Commissioner Li Li met with Hong Kong’s Secretary for Health Lo Chung-mau and senior health officials in Beijing to strengthen collaboration in pharmaceutical regulation. The meeting reaffirmed support for Hong Kong’s integration into national development, including the Greater Bay Area and the advancement of traditional Chinese medicine. Both sides committed to enhancing technical exchange, regulatory alignment, and innovation in drug review and evaluation. The dialogue builds on the Cooperation Agreement signed last year and reflects a shared vision for elevating public health standards across regions.

EGYPT

EDA Achieves ISO 17034:2016 Accreditation for Reference Materials

The Egyptian Drug Authority (EDA) successfully passed EGAC’s surveillance audit for ISO 17034:2016 compliance. This confirms EDA’s competence in producing certified reference materials for pharmaceutical quality control. The visit aligned with AFRAC and ARAC peer evaluations to expand EGAC’s international recognition. Technical and administrative processes were thoroughly reviewed, affirming EDA’s commitment to global standards. This milestone strengthens Egypt’s pharmaceutical credibility and boosts export potential. It also supports local industry with high-quality materials for regulatory and lab use.

INDIA

RTI Compliance Reminder on Internal Timelines & Procedures

To ensure timely disposal of RTI applications and appeals in line with the RTI Act, 2005, the First Appellate Authority (FAA) has issued strict procedural timelines following a review meeting held on August 28, 2025. All CDSCO divisions and officers must adhere to defined response windows ranging from 2 to 15 days based on the nature and scope of the RTI query or appeal. Delays in cases such as CDSCO/A/E/00036, 00040, and 00047 highlight the urgency of compliance. Weekly updates under Sue-Muto must be maintained on the CDSCO website. Non-compliance may attract penalties from the CIC, with accountability resting on the concerned DPIO or Division Head.

IBSC Approval Accepted for CT-10 Applications

As per the recommendation of the 314th RCGM meeting held on July 9, 2025, the Drug Regulatory Authority has accepted Institutional Biosafety Committee (IBSC) approval as valid for seeking permission to manufacture test items for examination, testing, and analysis via Form CT-10. This decision aligns with the communication from the Department of Biotechnology (Letter No. PID-15011(11)/3112021-PPB-DBT, dated July 21, 2015). Stakeholders are advised to take note and proceed accordingly.

INDONESIA

Indonesia Launches Joint Action to Combat Hazardous Materials in Drugs and Food

On September 15, 2025, the Indonesian Food and Drug Authority (BPOM) launched a joint initiative to tackle the supply chain of hazardous materials used in pharmaceuticals and processed foods. This multi-agency effort, involving seven ministries and five industry associations, aims to strengthen supervision from raw materials to finished products. BPOM reported a rise in drug and food-related crimes, with cases involving dangerous substances like formaldehyde, mercury, and tramadol. BPOM Head emphasized the need for cross-sector collaboration to protect public health and ensure product safety, especially as the market for medicines and food is projected to reach IDR 4,674 trillion. The initiative includes data sharing, joint operations, and a task force to curb misuse and promote a fair business environment.

BPOM and Barantin Strengthen Border Oversight of Pharmaceuticals and Food

BPOM and Barantin signed an MoU on September 12, 2025, to strengthen border supervision of pharmaceuticals and food products. The collaboration enhances oversight at ports, airports, and land borders, and includes joint efforts in regulation, lab testing, data sharing, and capacity building. This move supports public health and boosts domestic product competitiveness.

JAPAN

PMDA Alert on Promoting Safe Use of Drugs

The PMDA Alert for Proper Use of Drugs highlights pharmaceutical products linked to repeated adverse reactions or relief benefit claims, despite existing safety warnings. Issued by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), this resource uses clear language and graphic illustrations to help healthcare professionals better understand and apply safety precautions. The goal is to reinforce proper drug usage and prevent avoidable harm through enhanced awareness and vigilance.

PMDA-ATC MRCT/GCP Inspection Seminar 2026 on Advancing Global Clinical Trial Standards

The Pharmaceuticals and Medical Devices Agency (PMDA) will host the PMDA-ATC Multi-Regional Clinical Trial (MRCT)/Good Clinical Practice (GCP) Inspection Seminar 2026 in Tokyo from January 27–30, 2026. Organized under the APEC RHSC Center of Excellence, this in-person seminar is tailored for intermediate-level regulators with at least three years of hands-on experience in clinical trial review or GCP inspection. The program will focus on enhancing international harmonization of MRCTs and GCP inspections, sharing Japan’s expertise in protocol design and clinical data evaluation, and promoting MRCT development across Asia. With a participant cap of 30, registration closes on October 31, 2025. There is no registration fee, and materials will be provided electronically. Participants are advised to bring personal laptops and arrange their own travel insurance.

PMDA’s Fifth Mid-term Plan: Supporting Innovation Through Early Consideration

Under its Fifth Mid-term Plan (FY2024–FY2028), the Pharmaceuticals and Medical Devices Agency (PMDA) will strengthen consultation services and regulatory reviews to better support pharmaceutical innovation. A key initiative includes the issuance of Early Consideration documents reference materials that reflect current perspectives on the practical application of emerging technologies and the development of innovative drugs. These are based on evolving scientific knowledge and are subject to future updates. PMDA will also publish clinical evaluation guidelines and related resources to guide stakeholders. English translations are provided for convenience, but the Japanese originals remain authoritative.

JORDAN

JFDA Joins Launch of Foreign Trade & Logistics Portal

The Jordan Food and Drug Administration (JFDA) participated in launching a new digital portal to enhance trade efficiency. Led by Prof. Rana Obeidat, the event was hosted by the Customs Department with support from global partners. The portal provides real-time data on trade and logistics, helping reduce delays and improve border operations. It supports transparency, competitiveness, and reform efforts in Jordan’s business environment. The initiative is part of a broader SME-focused trade facilitation project backed by GIZ and international donors. JFDA’s involvement highlights its commitment to regulatory modernization and global cooperation.

NEW ZEALAND

Safety Reminder: Systemic Fluoroquinolones

MARC has updated safety guidance for ciprofloxacin, moxifloxacin, and norfloxacin. These antibiotics should be used only when first-line options are unsuitable. They may cause serious, potentially irreversible reactions tendon rupture, neuropathy, psychiatric effects, and liver failure. Adverse effects can occur in any patient, even months after treatment. Prescribers should follow local guidelines and advise patients to report symptoms promptly.

NIGERIA

NAFDAC Issues Alert on Falsified CIPROFIT 500 Tablets

NAFDAC warns the public about confirmed falsified CIPROFIT 500 (Ciprofloxacin 500mg) circulating in Nigeria. Lab tests revealed only 5.7% of the active ingredient, far below the required 90–110% range. The product falsely claims to be manufactured by Impact Pharmaceutical Ltd in Enugu State. All batches are affected and pose serious risks including treatment failure and antimicrobial resistance. This alert is part of NAFDAC’s ongoing safety monitoring and product recall efforts.

NAFDAC Warns Against Substandard ARTEMETRIN DS Tablets

NAFDAC has issued Public Alert No. 030A/2025 on confirmed substandard ARTEMETRIN DS (80mg/480mg). Lab tests revealed only 59.2% Artemether and 71.2% Lumefantrine far below acceptable limits. The product, labeled as manufactured by A.C. DRUGS Ltd, violates NAFDAC’s safety standards. Used to treat malaria, poor-quality tablets pose risks of treatment failure and resistance. Batch Q011G (MFG 07/23, EXP 06/25) is affected and should be avoided. This alert is part of NAFDAC’s ongoing effort to protect public health.

NAFDAC Publishes List of Withdrawn, Suspended & Cancelled Products

NAFDAC has released an official list of products no longer authorized for use in Nigeria. These items are banned from manufacture, import, export, distribution, sale, and advertisement. Withdrawals are initiated by Market Authorization Holders; suspensions reflect unmet license conditions. Cancellations occur when NAFDAC revokes a product’s registration due to regulatory violations. This action supports public health and ensures compliance with national drug safety standards. Full details are available in the September 19, 2025 update on NAFDAC’s website.

PERU

DIGEMID Issues Voluntary Recall of Injectable Medicines

Peru’s DIGEMID has announced a voluntary market withdrawal of select injectable products due to visible foreign particles. Affected products include Ketorolaco (30 mg/1 mL and 60 mg/2 mL), Bupivacaína 0.5%, and Cloruro de Sodio 0.9%. The recall involves multiple batches manufactured by Laboratorios Unidos S.A. and distributed by Dany S.A.C. DIGEMID has ordered a temporary shutdown of the sterile liquid production area for non-betalactamic drugs.

DIGEMID Reinforces Safety Measures for Paracetamol Combinations

Peru’s DIGEMID has reaffirmed limits on paracetamol dosage in combination medicines, especially with opioids. Products must not exceed 325 mg of paracetamol per dose and require reformulation if they do. Reformulated products may retain their original name with the suffix “NF” if efficacy and safety are supported. Label updates are mandated for adverse reactions, warnings, and contraindications in paracetamol and tramadol combos. These measures aim to reduce risks of liver toxicity and improve patient safety.

PHILIPPINES

FDA Philippines Issues Feedback on ASEAN Bioequivalence MRA

The Center for Drug Regulation and Research (CDRR) has released feedback on stakeholder comments regarding the proposed ASEAN Mutual Recognition Arrangement (MRA). The MRA covers bioequivalence study reports for generic medicinal products across ASEAN member states. This follows a public consultation aimed at harmonizing regulatory standards and facilitating regional market access. Stakeholders are encouraged to review the feedback and guidance provided in the official document.

SINGAPORE

Singapore HSA Launches eCTD Portal for Test Submissions

Singapore’s Health Sciences Authority (HSA) has launched its eCTD Portal for test submissions starting 30 September 2025. This six-month trial period, ending 27 March 2026, allows companies to familiarize themselves with the system before official dossier submissions begin on 1 April 2026. Submissions during the test phase will not undergo regulatory review and will be removed after the trial. HSA has provided training materials and a user manual to support users. Only dummy application numbers should be used during this phase, and actual applications must not be submitted via PRISM.

SOUTH AFRICA

SAHPRA Opens Consultation on Medicine Labelling Guideline

SAHPRA invites public input on its new guideline for labelling of human medicines (Categories A and D). The document aims to standardize label presentation and improve clarity for regulatory evaluation. Stakeholders can submit comments by October 6, 2025, using the official comment form. Submissions should be sent to Aseza.Matolengwe, Dillon.Singh, or Karin.Duxbury via email. This initiative supports consistency and safety in medicine registration and packaging.

SAHPRA Releases Updated General Information Guideline

SAHPRA has published the latest version of its General Information Guideline for human medicines. The document outlines regulatory expectations for safety, quality, and efficacy in medicine registration. It applies to biological and complementary medicines, excluding veterinary and device products. Version 13 reflects updates aligned with new processes and harmonized standards. Applicants must follow administrative requirements to avoid delays in evaluation.

VIETNAM

Vietnam MOH Issues New Administrative Procedures for Pharmaceutical Practices

The Ministry of Health (MOH) of Vietnam has officially issued a decision in 2025 to announce two newly established administrative procedures in the pharmaceutical sector. These procedures are based on updates to existing regulations governing Good Practices for retail pharmacies, drug distribution, and drug storage, as outlined in Circulars 02/2018/TT-BYT, 03/2018/TT-BYT, 36/2018/TT-BYT, and the newly amended Circular 11/2025/TT-BYT.

This decision, effective immediately upon signing, aims to streamline regulatory oversight and improve compliance across pharmaceutical operations. It reinforces Vietnam’s commitment to enhancing drug safety, distribution integrity, and retail standards nationwide. Provincial health departments and relevant stakeholders are instructed to implement the new procedures accordingly.

Nationwide Recall of Pyfaclor Kid Due to Quality Violation

Vietnam’s Drug Administration has issued a nationwide recall of Pyfaclor Kid (Cefaclor 125mg), batch number 410923, due to a Level 2 quality violation. Laboratory tests revealed the product failed to meet standards for physical properties and active ingredient content. The manufacturer, Pymepharco JSC, is required to halt distribution, notify stakeholders, and complete the recall within 15 days. Healthcare providers and retailers must stop dispensing the affected batch, while provincial health departments will oversee the recall process. This action reinforces Vietnam’s commitment to drug safety and regulatory compliance under Circular 30/2025/TT-BYT.

Vietnam MOH Clarifies Administrative Procedures for Pharmaceutical Management

The Drug Administration of Vietnam has issued updated guidance to provincial health departments regarding the implementation of key pharmaceutical administrative procedures. These include periodic evaluations of compliance with Good Distribution Practice (GDP) and Good Pharmacy Practice (GPP), revised licensing processes for pharmacists and mobile drug retail activities, and approval protocols for purchasing controlled substances. The updates align with recent decisions and decrees issued by the Ministry of Health, aiming to streamline operations, enhance regulatory oversight, and prevent supply disruptions. Provincial departments are urged to coordinate with local governments to ensure effective execution.