USA
FDA Clears First-in-Class Non-Opioid Treatment for Acute Pain
The U.S. Food and Drug Administration (FDA) has granted approval to Journavx (suzetrigine) 50 mg oral tablets for the management of moderate to severe acute pain in adults. This first-in-class, non-opioid analgesic selectively targets sodium channels in the peripheral nervous system, blocking pain transmission before signals reach the brain. The approval represents a significant milestone in the development of alternative pain management therapies amid ongoing concerns about opioid use.
CANADA
Federal–Ontario Partnership Expands Access to Rare Disease Therapies
Rare diseases affect approximately one in twelve Canadians, and many patients encounter substantial financial obstacles to obtaining treatment. To address these challenges, the Honourable Mark Holland, Canada’s Minister of Health, and the Honourable Sylvia Jones, Ontario’s Minister of Health, announced a bilateral funding agreement exceeding $535 million. The initiative will broaden access to selected new rare disease therapies, improve availability of existing treatments, and enhance early detection and screening programs.
EUROPE
Clinical Trials Regulation Now Fully Operational Across the EU
The European Union’s Clinical Trials Regulation (CTR) has become fully applicable, officially replacing the former Clinical Trials Directive (CTD). All clinical trials conducted in the EU—including those previously authorized under the CTD—are now governed by the CTR framework. The transition concludes a three-year migration period during which more than 5,000 trials were transferred to the Clinical Trials Information System (CTIS), the centralized EU platform for clinical trial submission and evaluation.
CHMP Issues Positive Opinion on Combination Therapy for Parasitic Worm Infections
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion for a fixed-dose combination of ivermectin and albendazole. The therapy is intended for adults, adolescents, and children aged five years and older for the treatment of soil-transmitted helminth infections and lymphatic filariasis. Targeted pathogens include hookworms (Ancylostoma duodenale, Necator americanus), roundworms (Ascaris lumbricoides), whipworms (Trichuris trichiura), and Strongyloides stercoralis—parasitic infections frequently associated with inadequate sanitation and contaminated soil exposure.
One Health Report Highlights Growing Azole Resistance in Aspergillus
Five EU health and environmental agencies, working alongside the European Commission’s Joint Research Centre (JRC), have published findings linking the widespread agricultural use of azole fungicides to increasing azole resistance in Aspergillus species. Applying a One Health framework, the report calls for coordinated efforts across human, animal, and environmental health sectors to mitigate antifungal resistance risks.
UNITED KINGDOM
MHRA Authorizes Seladelpar for Primary Biliary Cholangitis
On 16 January 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) approved seladelpar (Livdelzi) for adult patients with Primary Biliary Cholangitis (PBC), including those experiencing associated pruritus. Seladelpar is a peroxisome proliferator-activated receptor delta (PPAR-δ) agonist that helps reduce liver inflammation and improve disease management. It is indicated for use alongside ursodeoxycholic acid (UDCA) in patients who have shown inadequate response to UDCA, or as monotherapy for individuals unable to tolerate UDCA.
Enhanced Innovative Licensing and Access Pathway (ILAP) Launched
The United Kingdom has introduced an updated 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)—as well as the NHS. The enhanced pathway is designed to streamline regulatory and reimbursement processes, facilitating faster patient access to innovative and transformative therapies.
ASIA
INDONESIA
Scientific Address Emphasizes Urgency of Combating Antimicrobial Resistance
Taruna Ikrar, Head of Indonesia’s National Agency of Drug and Food Control (BPOM RI), delivered a scientific lecture titled “The Threat of a Silent Pandemic Due to Antimicrobial Resistance.” The address was presented at Universitas Prima Indonesia in Medan, North Sumatra, during a ceremony honoring distinguished scientists. The speech highlighted the escalating global challenge posed by antimicrobial resistance and the need for strengthened policy and scientific action.
JAPAN
Electronic Package Inserts Fully Integrated into Regulatory Practice
Following revisions to Japan’s Pharmaceuticals and Medical Devices Act, paper-based package inserts have largely been phased out since August 2021. Product information is now primarily disseminated through electronic package inserts. Authorities have issued detailed guidance outlining access methods and system specifications for healthcare professionals and patients. The framework remains subject to future refinements as implementation evolves.
Clinical Evaluation Framework for Palmoplantar Pustulosis Therapies
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has released its current considerations for assessing clinical efficacy in treatments targeting palmoplantar pustulosis (PPP). These perspectives were discussed with academic and industry representatives at the March 2024 annual meeting of the Japan Society of Clinical Trials and Research (JSCTR). A summary of the discussions has been published in The Japanese Pharmacology & Therapeutics.
PHILIPPINES
Updated Contact Information for CFRR Licensing and Registration Division
The Food and Drug Administration 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), strengthening communication channels with regulated stakeholders.
THAILAND
Advancing Harmonized Nationwide Health Product Regulation
Thailand’s Food and Drug Administration is working in collaboration with provincial public health offices to develop a standardized operating manual covering both pre-market and post-market regulation of health products. The initiative aims to harmonize regulatory oversight across provinces and improve administrative efficiency. A workshop to review the draft manual took place from 6–8 January 2025 at the Centara Life Government Complex Hotel & Convention Center in Bangkok, bringing together provincial representatives and FDA officials.
