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

AUSTRALIA

Australia Adopts 19 International Scientific Guidelines On May 29, 2025

the TGA announced the adoption of 19 international scientific guidelines following public consultation. These guidelines support sponsors in meeting regulatory requirements for medicines in Australia, covering areas such as bioequivalence, pharmacovigilance, vaccines, gene therapies, and real-world data.

Updated GMP Clearance Information for Sponsors May 21, 2025

Updates to GMP clearance resources include guidance on Health Canada inspection reliance, use of Letters of Access, and evidence requirements under Annex 16 of the PIC/S Guide to GMP. The application user guide has also been revised with new e-form instructions.

Updated Guillain-Barre Syndrome Warning for RSV Vaccines Arexvy and Abrysvo May 19, 2025

The RSV vaccines Arexvy and Abrysvo have an updated safety warning to include a rare risk of Guillain-Barré syndrome, a neurological condition causing muscle weakness. The risk is very low, and the benefits of vaccination for older adults and pregnant women remain strong. Health professionals should inform patients about symptoms and monitor for signs of GBS.

BRAZIL

SCMED holds webinar on monitoring the pharmaceutical market- May 06, 2025

On May 5, 2025, SCMED/Anvisa hosted a webinaron pharmaceutical market monitoring, covering drug taxation, CMED price lists, and a new complaint submission system. The training aimed to enhance coordination among health departments and improve regulatory oversight. Questions can be sent to cmed@anvisa.gov.br with the subject “Webinar – monitoring of the pharmaceutical market.”

CHINA

7th Asian Network Meeting on Drug Regulation – May 05, 2025

The 7th Asian Network Meeting took place on April 23, 2025, in a hybrid format, with both in-person and virtual participation. The meeting brought together drug regulatory authorities from nine Asian countries China, India, Indonesia, Japan, South Korea, Malaysia, the Philippines, Singapore, and Thailand to discuss ongoing challenges and foster regional collaboration in pharmaceutical regulation.

Huang Guo, Deputy Commissioner of China’s National Medical Products Administration (NMPA), delivered a keynote speech virtually. He emphasized China’s recent strides in reforming drug and medical device regulations. These reforms are part of the country’s strategy to ensure drug safety and support the high-quality development of its pharmaceutical sector. Huang also expressed hope that the meeting would enhance cooperation and regulatory alignment across Asia.

During the meeting, participating countries shared regulatory updates, and held in-depth discussions on key issues, including:

• Challenges in clinical trials
• Strategies for regulatory reliance
• Enhancing regulatory convergence within the region

Officials from the NMPA and its affiliated institutions were present, underscoring China’s active role in promoting international dialogue and cooperation in drug regulation.

INDIA

Suspected Spurious Batch of Nandrolone Decanoate Injection Identified

In the Drug Alert for April 2025, a batch of Nandrolone Decanoate Injection IP 50 mg/ml (Decadurabolin 50 Inj.), bearing batch number G303123 and dated November 2023 (expiry: October 2027), has been flagged as potentially spurious. The sample was drawn by the Drugs Inspector in Bihar, and the failure was reported based on issues with the identification and assay of Nandrolone Decanoate. The company named on the label has denied manufacturing this batch, indicating it may be falsely attributed and thus spurious. While it is purported to be a spurious drug, the final determination awaits the outcome of a detailed investigation.

Alert on Substandard Drug Batches by CDSCO/Central Laboratories

In April 2025, the CDSCO/Central Laboratories issued a Not of Standard Quality (NSQ) alert highlighting various drug batches found substandard through continuous regulatory surveillance. Notable NSQ drugs include Carboxymethyl Cellulose Sodium Eye Drops (batches MO24H21, MO24H22, MO24H27) by M/s. Martin & Brown Biosciences Pvt. Ltd., failing pH, sterility, and assay tests; Bupivacaine Hydrochloride Injection by Themis Medicare Limited, showing particulate matter issues; Ceftriaxone and Sulbactam for Injection by MMG Healthcare, with bacterial endotoxin concerns; and Pantoprazole Gastro-Resistant Tablets by Mancare Laboratories, failing dissolution tests. Multiple batches of Calcium Carbonate 500 mg + Vitamin D3 tablets by Gidsha Pharmaceuticals failed dissolution tests for calcium. Other drugs flagged include Amikacin Sulphate Injection by SAI Parenterals Limited with particulate matter issues, Sucralfate & Oxetacaine Suspension by Tidal Laboratories failing identification and assay tests, and several batches of Iron Sucrose Injection by SAI Parenterals with pH and alkalinity failures. Additionally, various injectable and oral drugs such as Compound Sodium Lactate Injection by Aculife Healthcare, Rifampicin, Isoniazid & Ethambutol Tablets by Centurion Remedies, and several batches of Sulbactam Sodium Sterile imported by Shah TC Distribution LLP were found to have issues related to sterility, assay, identification, and related substances. Other drugs flagged include Ciprofloxacin Tablets by Cadila Pharmaceuticals and Nestor Pharmaceuticals for dissolution failures, and several veterinary, dermatological, and combination tablets with dissolution, assay, or particulate issues reported by respective manufacturers. This alert serves to inform stakeholders of these NSQ batches to ensure drug safety and efficacy in the market.

INDONESIA

BPOM Dismantles Illegal Drug and OBA Production Network in Central Java, Protects Public from Health Threats May 27, 2025

The BPOM, in collaboration with the Central Java Regional Police, raided five illegal drug and natural medicine production sites in Klaten on May 7–8, 2025. Authorities confiscated over 117,000 illegal products, including counterfeit medications containing dexamethasone, paracetamol, and tadalafil. The estimated economic value of the seized items reached 2.84 billion rupiah.

A similar enforcement action occurred in Kudus on April 15, 2025, where 97 types of illegal drugs were seized. BPOM confirmed that these products were being distributed nationwide, posing serious health risks. One suspect has been arrested in connection with the Klaten case, and violators face up to 12 years in prison or fines of 5 billion rupiah under health laws. BPOM urges consumers to remain cautious and report suspicious products to authorities.

BPOM Launches 3 Innovative Programs to Promote National Drug Independence May 19, 2025

BPOM has launched three innovative programs to strengthen Indonesia’s pharmaceutical sector and accelerate drug independence. The programs were unveiled by BPOM Head Taruna Ikrar on May 19, 2025, in Jakarta.

1. Joint Supplier Audit Program – A collaboration with GPFI, allowing collective audits of raw material suppliers, verified by BPOM to ensure quality and efficiency.
2. SIGAP KLINIK – A fast-track clinical trial licensing program to streamline approval within 20 days, coupled with free online training on good clinical trial practices.
3. Pharmacist Competency Development – A partnership with IAI to enhance pharmacist expertise in drug registration, production, and distribution.

BPOM emphasized cross-sector collaboration as key to overcoming import dependency, technology adaptation, and global challenges. The initiative aims to build a competitive, independent national pharmaceutical system, ensuring safe and affordable medicines for Indonesian citizens.

BPOM Approves Phase 3 Clinical Trials of Tuberculosis Vaccine in Indonesia May 15, 2025

The BPOM has approved the phase 3 clinical trial of the M72 tuberculosis vaccine, developed by GSK, in Indonesia. The announcement was made during a Gates Foundation visit on May 15, 2025. The trial is part of a multinational study across seven countries, aiming to recruit 2,095 Indonesian subjects at five clinical trial centers.

BPOM’s approval follows a rigorous review ensuring ethical, scientific, and safety standards. Given Indonesia’s high TB burden, the trial is expected to enhance treatment availability. BPOM also seeks collaboration with the Gates Foundation to strengthen vaccine research, regulation, and testing.

Head of BPOM Reviews Cakung Health Center Pharmacy Installation, Ensures Good Drug Management  May 02, 2025

BPOM Head Taruna Ikrar visited Cakung Community Health Center (Puskesmas) on May 2, 2025, to oversee pharmaceutical installations and ensure proper drug management in health facilities. He emphasized the critical role of pharmacies in healthcare and BPOM’s authority to supervise drug safety, efficacy, and quality.

BPOM also encouraged active control of antimicrobial resistance and participation in the Free Nutritious Meals (MBG) program to support public health. The visit included inspections, staff discussions, and patient dialogues, with BPOM reaffirming its commitment to quality healthcare and stronger pharmaceutical oversight.

LEBANON

Pharmaceutical Products Recalled from the Lebanese Market according to Minister’s Decision No. 753/1, May 13 2025

Lebanese Ministry of Public Health bans the import and circulation of counterfeit medical products.

• Product: HEALMOXY Capsules 500 mg (Amoxicillin)
• Manufacturer: MAXHEAL Pharmaceuticals (India)
• Affected Batches: 023011, H02605, H026051 (Expiry: 2025–2027)
• Identified in: African Region
• Enforcement: Pharmaceutical Inspection Department

This decision follows a WHO warning on counterfeit medical products to safeguard public health. Notifications have been sent to health authorities, medical syndicates, and importers002E

MALAYSIA

List of Unregistered/Registered But Not Marketed Products with the Highest Number of Special Approval (UKK) Drug Applications for the Year 2024 ,May 5, 2025

The National Pharmaceutical Regulatory Division (NPRA) has released a list of 50 unregistered or registered but non-marketed products with the highest number of Special Approval (UKK) drug applications in 2024. Under Regulation 15(6) of the Drug Control and Cosmetics Regulations 1984, health facilities can apply for UKK exemptions to use unregistered drugs for life-threatening diseases.

The NPRA urges Product Registration Holders (PRH) and industry associations to register and market these products to ensure patients have access to necessary treatments. Registration applications must comply with PSKD requirements and be complete in documentation.

NIGERIA

Update on the Ongoing Enforcement Operation on the Open Drug Markets in Nigeria ,May 30, 2025

NAFDAC conducted a major enforcement operation from February 9 to March 27, 2025, in Open Drug Markets (Idumota, Aba, and Onitsha), seizing over a trillion Naira worth of banned, expired, and falsified narcotics.

• Shops & warehouses lacked proper storage standards and PCN registration.
• Perpetrators faced investigative charges (N5M for unregistered products, N2M for storage violations, later reduced).
• Bridge Head Market reopened on March 9, 2025, with 2,500 traders resuming operations after regulatory compliance.
• NAFDAC remains committed to ensuring safe, high-quality medicines and protecting public health.

Pharmaceutical Alert: Market Recall, May 19, 2025

Product: CS PISA Injectable Solution 0.9% (Sodium Chloride) Batch: P23N838 | Expiration: 11/2025 Recall Date: May 19, 2025 | Recall Type: Instructed Issue: Presence of a foreign body inside a sealed container Manufacturer: Laboratories PISA de C.V., Mexico Sanitary Registration Holder: PISA Farmaceutica de Chile S.P.A.

Healthcare providers should immediately stop distribution and return affected stocks. Stay updated for further recall instructions.

Information Note on The Abrysvo® And Arexvy® Vaccines for Respiratory Syncytial Virus in People Over 60 Years of Age and Their Possible Association with Guillain-Barré Syndrome, May 19, 2025

The FDA has published safety information regarding the RSV vaccines Abrysvo® and Arexvy®, highlighting their possible association with Guillain-Barré Syndrome (GBS) in adults 60+ years old.

• Chile offers free monoclonal antibody nirsevimab (Beyfortus®) for infants, showing positive results in reducing RSV-related deaths.
• RSV is highly contagious, affecting infants, older adults, and immunocompromised individuals.
• The Institute of Public Health has issued recommendations for vaccine administration in light of potential GBS risks.

Pharmacovigilance Information Noterisks and Precautions for the Use of Ibuprofen: Important Information for Health Professionals and Patients May 9, 2025

Pharmacovigilance Alert: Ibuprofen Risks

The Public Health Institute warns of serious adverse reactions associated with ibuprofen, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and Kounis syndrome (cardiovascular risk). Contraindicated in third-trimester pregnancy due to fetal toxicity risks.

• NSAID for pain relief & fever—use with caution, especially high doses requiring prescription.
• EMA & health agencies recommend updates to marketing authorization conditions.
• Report adverse reactions via the Integrated Surveillance System.

PHILIPPINES

FDA Press Statement || FDA Director General Urges Suspension of New Regulatory Fees  May 26, 2025,

The Food and Drug Administration (FDA) has urged the Department of Health to suspend Administrative Order No. 2024-0016, which increases registration fees for health products. The suspension, if approved, will be effective for 60 days starting seven days after approval.

FDA Director General Paolo S. Teston emphasized fair and transparent policy reforms during a May 26, 2025, House briefing, highlighting the need for service improvements before fee increases. The FDA is committed to modernizing regulatory services, enhancing employee welfare, and ensuring access to safe health products.

SINGAPORE

Mean applicant screening response time May 28, 2025

HSA’s target screening turn-around-time from the date of receipt of the application dossier to the date of acceptance or non-acceptance/withdrawal of the application (excluding applicant’s response time) is 50 working days (WD)

For the new and major variation applications accepted within the period of 01 Oct 2024 to 31 Mar 2025, the mean screening time taken by HSA was 33.0 WD for NDA, 34.3 WD for GDA and 24.0 WD for MAV applications respectively.

New drug indication approval May 15, 2025

The recently approved pharmaceutical products (April 2025):

• BOTOX® (AbbVie PTE. LTD.) – Approved April 10, 2025, for benign masseter muscle hypertrophy in bruxism.
• BLINCYTO (Amgen Biotechnology Singapore PTE LTD) – Approved April 28, 2025, for CD-19-positive B-cell precursor ALL in adults & children.
• FASENRA (AstraZeneca Singapore PTE LTD) – Approved April 21, 2025, as add-on therapy for eosinophilic granulomatosis with polyangiitis.
• OLUMIANT (DKSH Singapore PTE. LTD.) – Approved April 9, 2025, for juvenile idiopathic arthritis & atopic dermatitis in patients 2+ years.
• JEMPERLI (GlaxoSmithKline PTE LTD) – Approved April 15, 2025, for advanced or recurrent endometrial cancer with carboplatin & paclitaxel.
• TRIMBOW (Orient Europharma PTE LTD) – Approved April 30, 2025, for moderate-to-severe COPD & asthma maintenance treatment.

HSA Alert: “Curalin Advanced Glucose Support” Recalled Due to Detection Of Prescription-Only Medicines For Diabetes May 5, 2025

HSA warns against consuming “CuraLin advanced glucose support” due to undisclosed prescription-only drugs (glibenclamide, metformin). Sales and two batches (2023-19650, 2023-19651) are being recalled. Health risks include low blood sugar, seizures, and overdose effects.

Consumers should stop use immediately and consult a doctor if unwell. Sellers must halt sales or face penalties. Report violations to HSA Enforcement (6866-3485, hsa_is@hsa.gov.sg).

Recall of Nutriflex Omega Special Emulsion For Infusion May 02, 2025

Retail-level recall issued for Nutriflex Omega Special Emulsion For Infusion (Batch 240678051) on April 29, 2025, due to out-of-specification particles.

• Product: Parenteral nutrition solution
• Recall Level: Retail (hospitals, pharmacies, clinics)
• Local Company: B. Braun Singapore Pte Ltd
• Action: Stop supply & return remaining stocks

The Health Sciences Authority (HSA) ensures recalls maintain quality, safety, and efficacy. Class 2 recalls indicate low health risk, but quality standards must be met.

SOUTH KOREA

Ministry of Food and Drug Safety approves rare small cell lung cancer treatment May 30, 2025

The Ministry of Food and Drug Safety (MFDS) has approved Imdeltraju (Talatamab) 1mg/10mg on May 30, 2025, for treating relapsed or refractory small cell lung cancer (SCLC) in adult patients who have undergone platinum-based chemotherapy and at least two prior treatments. As a bispecific antibody, the drug activates T-cells to target DLL3 protein, leading to cancer cell destruction.

The approval was expedited under the Global Innovation Product Rapid Review Support System (GIFT) to ensure quick access to innovative therapies. MFDS reaffirmed its commitment to enhancing treatment availability for rare and incurable diseases, supporting swift drug approvals in the domestic medical field.

Increasing predictability of pharmaceutical supply shortages- May 26, 2025

The Ministry of Food and Drug Safety (MFDS) has revised the Drug Reporting Regulations on May 26, 2025, to enhance predictability of pharmaceutical shortages. The updated notice requires mandatory reporting of supply interruptions 180 days in advance (previously 60 days) and outlines criteria for reporting obligations, exceptions, and detailed procedures. Companies must report production/import suspensions exceeding 3 months or market supply halts exceeding 1 month. The revision aims to strengthen regulatory oversight and ensure a stable pharmaceutical market. More details are available on the MFDS website (www.mfds.go.kr).

Ministry of Food and Drug Safety conducts education on ’25-year pharmaceutical approval patent linkage system’ May 28, 2025

The Ministry of Food and Drug Safety (MFDS) will conduct pharmaceutical approval patent linkage system training from June 16–18, 2025, at COEX, Seoul. The training includes institutional education (June 16–17) on policy direction, litigation trends, and overseas systems, followed by practical training (June 18) on patent information searches. Participants must bring laptops for hands-on learning. Registration is open May 28–June 8 via the Korea Intellectual Property Protection Agency website (koipa.re.kr) or by phone (02-6196-2067, 2071). MFDS aims to strengthen pharmaceutical patent expertise and support industry innovation through this training.

Approval of over-the-counter tick repellents → Relaxation of reporting system May 21, 2025

The Ministry of Food and Drug Safety (MFDS) announced a revision to the Standard Manufacturing Standards for Non-Pharmaceutical Products on May 21, 2025, expanding criteria for repellents. The update broadens Diethyltoluamide-based repellents to cover mosquitoes and ticks and simplifies reporting procedures for manufacturers. The revision aims to reduce industry burdens, speed up productization, and offer consumers more repellent options. Public comments are open until June 10, 2025 via the MFDS website (www.mfds.go.kr).