USA
FDA Authorizes First-in-Class Non-Opioid Therapy for Acute Pain
The U.S. Food and Drug Administration (FDA) has approved Journavx (suzetrigine) 50 mg oral tablets, a novel non-opioid treatment indicated for moderate to severe acute pain in adults. As a first-in-class analgesic, Journavx works by selectively targeting sodium channels within the peripheral nervous system, interrupting pain signaling before it reaching the brain.
CANADA
Federal–Ontario Agreement to Expand Access to Drugs for Rare Diseases
Approximately one in twelve Canadians is affected by a rare disease, with many patients facing significant financial barriers to treatment. To improve access, the Honourable Mark Holland, Canada’s Minister of Health, and the Honourable Sylvia Jones, Ontario’s Minister of Health, announced a bilateral agreement providing more than $535 million in funding. The investment will support access to selected new therapies for rare diseases, enhance availability of existing treatments, and strengthen early diagnosis and screening initiatives.
EUROPE
Clinical Trials Regulation Fully Implemented
The Clinical Trials Regulation (CTR) is now fully applicable across the European Union, replacing the former Clinical Trials Directive (CTD). All clinical trials, including those previously authorized under the CTD, are now governed by the CTR. This concludes a three-year transition period during which over 5,000 trials were migrated to the new framework via the Clinical Trials Information System (CTIS), the centralized EU portal for clinical trial submissions and assessments.
Positive Opinion for Combination Therapy Against Parasitic Worm Infections
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for the combination of ivermectin and albendazole. The therapy is indicated for adults, adolescents, and children aged five years and older for the treatment of soil-transmitted helminth infections and lymphatic filariasis. Targeted parasites include hookworms (Ancylostoma duodenale, Necator americanus), roundworms (Ascaris lumbricoides), whipworms (Trichuris trichiura), and Strongyloides stercoralis. These infections are commonly associated with poor sanitation and contaminated soil.
One Health Initiative Addresses Azole Resistance in Aspergillus
Five EU health and environmental agencies, in collaboration with the European Commission’s Joint Research Centre (JRC), have released a report highlighting the link between widespread agricultural use of azole fungicides and the emergence of azole-resistant Aspergillus fungi. Using a One Health approach, the agencies emphasize coordinated action across human, animal, and environmental health sectors to mitigate the growing risk of antifungal resistance.
UNITED KINGDOM
MHRA Approves Seladelpar for Primary Biliary Cholangitis
On 16 January 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) approved seladelpar (Livdelzi) for the treatment of adults with Primary Biliary Cholangitis (PBC), including associated pruritus. Seladelpar, a peroxisome proliferator-activated receptor delta (PPAR-δ) agonist, reduces liver inflammation and improves disease control. It is indicated for use in combination with ursodeoxycholic acid (UDCA) in patients with an inadequate response to UDCA, or as monotherapy in those who cannot tolerate UDCA.
Launch of the Enhanced Innovative Licensing and Access Pathway (ILAP)
The UK has introduced a revamped Innovative Licensing and Access Pathway (ILAP), developed collaboratively by the MHRA, Health Technology Assessment bodies—including the All Wales Therapeutics and Toxicology Centre (AWTTC), the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC)—and the NHS. The integrated pathway aims to accelerate patient access to transformative medicines through improved coordination across regulatory and reimbursement processes.
ASIA
INDONESIA
Scientific Address Highlights Antimicrobial Resistance Threat
The Head of Indonesia’s National Agency of Drug and Food Control (BPOM RI), Taruna Ikrar, delivered a scientific oration entitled “The Threat of a Silent Pandemic Due to Antimicrobial Resistance.” The address was presented during a ceremony recognizing influential scientists at Universitas Prima Indonesia in Medan, North Sumatra. The speech underscored the growing global risk posed by antimicrobial resistance.
JAPAN
Electronic Package Inserts Now Standard Practice
Following amendments to the Pharmaceuticals and Medical Devices Act, paper package inserts have largely been discontinued since August 2021. Product information is now primarily provided through electronic package inserts. Authorities have issued guidance outlining how healthcare professionals and patients can access these digital inserts, along with details regarding system specifications. The information remains subject to future updates.
Considerations for Clinical Evaluation of Treatments for Palmoplantar Pustulosis
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has outlined its current perspective on evaluating clinical efficacy for therapies targeting palmoplantar pustulosis (PPP). Discussions were held with academic and industry stakeholders at the March 2024 annual meeting of the Japan Society of Clinical Trials and Research (JSCTR). A summary of these deliberations has been published in The Japanese Pharmacology & Therapeutics.
PHILIPPINES
New Contact Details for CFRR Licensing and Registration Division
The Food and Drug Administration (FDA) of the Philippines has announced new official email addresses for the Licensing and Registration Division (LRD) under the Center for Food Regulation and Research (CFRR), enhancing communication channels for stakeholders.
THAILAND
Strengthening Nationwide Health Product Regulation
Thailand’s Food and Drug Administration is collaborating with provincial public health offices to develop a standardized operating manual governing pre- and post-market regulation of health products. This initiative aims to harmonize regulatory practices nationwide and improve operational efficiency. A workshop to review the draft manual was held from 6–8 January 2025 at the Centara Life Government Complex Hotel & Convention Center in Bangkok, with participation from provincial officials and FDA representatives.
