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

USA

FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

The U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain.

EUROPE

Clinical Trials Regulation becomes fully applicable

All clinical trials in the European Union (EU), including ongoing trials that were approved under the previous legal framework, the Clinical Trials Directive (CTD), are governed by the Clinical Trials Regulation (CTR). This marks the end of a three-year transition period, during which more than 5,000 clinical trials were transitioned to the CTR through submission to the Clinical Trials Information System (CTIS), the single-entry point for sponsors and regulators for the submission and assessment of applications for clinical trials in the EU.

New combination of medicines to treat parasitic worm infections

EMA’s human medicines committee (CHMP) has adopted a positive scientific opinion for Ivermectin/Albendazole for the treatment of infections caused by several types of worm parasites including lymphatic filariasis, a neglected tropical disease.

Ivermectin/Albendazole is indicated for use in adults, adolescents and children 5 years or older, for the treatment of soil-transmitted helminth infections (STH), caused by different types of intestinal parasitic worms, which are spread through soil contaminated by human faeces in areas with poor sanitation. Among the worms responsible for these diseases are hookworms (Ancylostoma duodenale, Necator americanus), roundworms (Ascaris lumbricoides), whipworms (Trichuris trichiura) and a roundworm called Strongyloides stercoralis.

One Health: EU agencies unite to tackle azole fungicide resistance in Aspergillus fungi

The extensive use of azole fungicides (azoles), particularly in some agricultural and horticultural practices, can increase the risk of Aspergillus fungi developing resistance to essential antifungal treatments. This significant finding is highlighted in a report by the five EU health and environment agencies, with support from the European Commission’s Joint Research Centre (JRC). The Agencies collaborated under a One Health approach to address this growing threat.

AUSTRALIA

Don’t risk using tanning products containing melanotan

Australians who use tanning products containing ‘melanotan’ are at risk of serious health problems.

These products include nasal sprays and other injectable and ingestible tanning products, and are being illegally promoted and sold online.

Melanotans are synthetic peptides that increase melanin production in the skin to give it a tanned appearance. They are often listed on the label as Melanotan I or Melanotan II.

CANADA

Government of Canada signs bilateral agreement with Ontario for Drugs for Rare Diseases

In Canada, 1 in 12 people live with a rare disease, and for most people affected, the cost of treatment is unaffordable.  Canadians deserve a health care system that provides timely access to quality health services and medications, including effective drugs for rare diseases, regardless of where they live or their ability to pay.

The Honourable Mark Holland, Canada’s Minister of Health, and the Honourable Sylvia Jones, Ontario’s Minister of Health, announced a bilateral agreement  investing over $535 million to improve  access to selected new drugs for rare diseases, and to support enhanced access to existing drugs, early diagnosis, and screening.

INDONESIA

Cadets Pledge Remind of Threat of Silent Pandemic Due to Antimicrobial Resistance

Head of BPOM RI Taruna Ikrar delivered a scientific oration themed The Threat of Silent Pandemic Due to Antimicrobial Resistance. This scientific oration was presented by Taruna in a series of activities   for the awarding of influential scientist titles in Indonesia from Unpri Medan Head of BPOM RI Taruna Ikrar at the Ballroom of Universitas Prima Indonesia (Unpri) Medan, North Sumatra

JAPAN

Information regarding newly introduced electronic package inserts

Following the amendment of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Pharmaceuticals and Medical Devices Act), paper-based package inserts that used to be enclosed with products are abolished in principle from August 2021 Note). Basically, package inserts should be browsed electronically. This page introduces how the electronic package inserts are browsed, and their detailed systems and specifications. The information on this page is current as of 2021 and will be updated in the future.

Points to Consider for Clinical Efficacy Evaluation of Drugs for Palmoplantar Pustulosis

The Pharmaceuticals and Medical Devices Agency (PMDA) had explained the reviewer’s current thinking about clinical efficacy assessment of drugs for treatment of palmoplantar pustulosis (PPP) and exchanged views with relevant parties including academia and industry at the annual meeting of the Japan Society of Clinical Trials and Research (JSCTR) in March 2024. The summary of the discussion was published in an article in The Japanese Pharmacology & Therapeutics.

PHILIPPINES

Announcement of the newly created Center for Food Regulation and Research (CFRR) Licensing and Registration Division (LRD) email addresses.

We are pleased to announce that the Licensing and Registration Division (LRD) of the Center for Food Regulation and Research (CFRR), Food and Drug Administration (FDA) has the following NEW official email addresses.

THAILAND

FDA Proactive Approach Improving the Health Product Regulatory System to Align Nationwide

The FDA cooperates with the provincial public health offices across the country to develop a standard operating manual for regulating health products before and after they enter the market, ensuring unified nationwide procedures. This initiative aims to align operations, link networks together, and ensure efficient coverage.

The Food and Drug Administration (FDA), opened a workshop seminar to review the draft manual for standard operating procedures for regulating health products. This seminar was organized from 6-8 January 2025 at Centara Life Government Complex Hotel & Convention Center Chaeng Watthana, Bangkok. Officials from provincial public health offices nationwide, as well as FDA staff, participated in the meeting.

UK

Seladelpar approved to treat adult patients in the UK with liver illness

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 16 January 2025, approved the medicine seladelpar (Livdelzi) in adults for the treatment of a liver illness called Primary Biliary Cholangitis (PBC), including pruritus. It works by controlling liver problems in the body and making the liver less inflamed. Seladelpar belongs to a group of medicines called peroxisome proliferator-activated receptor delta agonists. The medicine can only be prescribed to adult patients with PBC, including pruritus, in combination with ursodeoxycholic acid (UDCA) who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. 

UK patients enabled access to transformative new medicines in shortest time possible via new, integrated Innovative Licensing and Access Pathway

The new ILAP has been launched by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Technology Appraisal Bodies (the All Wales Therapeutics and Toxicology Centre (AWTTC), the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC)) and the NHS.