Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Jan 2025

USA

FDA Approves a New Non-Opioid Therapy for Acute Pain

The U.S. Food and Drug Administration has officially approved for Journavx (suzetrigine) 50 mg oral tablets, marking the introduction of a novel non-opioid pain medication for adults experiencing moderate to severe acute pain. The drug works by blocking specific sodium channels involved in pain signaling within the peripheral nervous system, reducing pain before signals reach the brain.

EUROPE

Full Implementation of the Clinical Trials Regulation

All clinical trials in the European Union are now governed under the Clinical Trials Regulation (CTR), concluding the three-year transition from the previous Clinical Trials Directive (CTD). More than 5,000 trials have been successfully transitioned through the Clinical Trials Information System (CTIS), the centralized platform for clinical trial submissions and regulatory review across the EU.

New Combination Treatment for Parasitic Worm Infections

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has provided a favorable recommendation for Ivermectin/Albendazole to treat a range of parasitic worm infections, including lymphatic filariasis. The treatment is intended for adults and children aged 5 years and older for soil-transmitted helminth infections, commonly found in regions with inadequate sanitation.

One Health Initiative to Combat Antifungal Resistance

EU health and environmental agencies, with support from the European Commission’s Joint Research Centre, have emphasized growing resistance to antifungal treatments caused by extensive agricultural use of azole fungicides. Collaborative action under the One Health framework aims to reduce the risk and improve monitoring strategies.

AUSTRALIA

Warning Against Tanning Products Containing Melanotan

The Australian government has issued a warning against the use of products containing melanotan—often sold online as nasal sprays, injectable solutions, or ingestible tanning aids. These synthetic peptides artificially increase melanin levels and may lead to serious health risks. The sale and promotion of melanotan products in Australia is illegal.

CANADA

Federal and Ontario Governments Partner to Improve Access to Rare Disease Medicines

To expand access to affordable treatments for rare diseases, the Government of Canada and the Province of Ontario have entered into a joint agreement to establish a bilateral agreement committing over $535 million. The initiative aims to improve availability of new and existing therapies, enhance early diagnosis, and support patient care across the province.

INDONESIA

Highlighting the Growing Threat of Antimicrobial Resistance

In a scientific address, the Head of BPOM RI, Taruna Ikrar, highlighted the escalating worldwide threat posed by antimicrobial resistance (AMR), referring to it as a potential “silent pandemic.” The message was delivered during an academic recognition ceremony at Universitas Prima Indonesia in Medan, reinforcing the need for stronger surveillance and responsible antibiotic use.

JAPAN

Shift to Electronic Access for Package Inserts

Following updates to pharmaceutical legislation, Japan has transitioned away from paper-based package inserts since August 2021. Product information is now primarily accessed electronically. Updated guidance explains how to access and interpret digital package insert systems, with future updates anticipated.

Guidance on Evaluating Therapies for Palmoplantar Pustulosis

The PMDA shared current regulatory perspectives on evaluating the clinical efficacy of treatments for palmoplantar pustulosis (PPP) during the 2024 JSCTR meeting. A published summary outlines key discussion outcomes aimed at aligning research methods and regulatory expectations.

PHILIPPINES

New Official Email Addresses for the CFRR Licensing and Registration Division

The Philippine FDA has released updated official email addresses for the Licensing and Registration Division of the Center for Food Regulation and Research (CFRR) to streamline communications and regulatory submissions.

THAILAND

Strengthened National Coordination for Health Product Regulation

The Thai FDA has partnered with provincial health authorities to standardize nationwide procedures for regulating health products before and after market entry. A January 2025 workshop convened regulators to review and finalize operational guidelines to ensure consistency across regions.

UK

Approval of Seladelpar for Primary Biliary Cholangitis

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for seladelpar (Livdelzi) for the treatment of Primary Biliary Cholangitis (PBC) in adults, including those experiencing pruritus. The medicine may be used alongside ursodeoxycholic acid (UDCA) or as a standalone option for patients unable to tolerate UDCA.

Launch of the Innovative Licensing and Access Pathway (ILAP)

The MHRA, in collaboration with national health technology assessment bodies and the NHS, has launched the Innovative Licensing and Access Pathway (ILAP) to accelerate patient access to groundbreaking medications in the UK.