Regulatory Revolution in Japan: The New Pathway for “Specific Use Drugs” in 2026
In 2026, Japan is implementing a structural change in its drug designation process. The new workflow allows companies to apply for the “Drug for Specific Use” classification directly to the PMDA (Pharmaceuticals and Medical Devices Agency), eliminating previous ministerial bureaucratic hurdles and accelerating the arrival of treatments for rare and critical diseases in the Japanese market.
PMDA Modernizes Drug Approvals: The Strategic Rise of Real-World Data (RWD) in Japan
The PMDA’s recent transition to a more agile, data-driven approval model. The focus is on how the integration of ‘real-world’ evidence is redefining access to the Japanese market for global pharmaceutical companies.
Navigating Japan’s New SaMD Regulations: The Dual Frontier of AI and Cybersecurity
This Blog analyses critical PMDA updates for 2026, focusing on artificial intelligence governance and cyber protection for medical software, which are essential for ensuring operational continuity in the Japanese market.
The SAKIGAKE Designation Expansion: Fast-Tracking Breakthrough Innovation in Japan
This post details the strategic expansion of the SAKIGAKE system in 2026, a regulatory accelerator that redefines the market entry timeline for cutting-edge therapies and orphan drugs in Japan.
Brazilian Ministry of Health will train professionals to identify patients with rare diseases
Among the actions the Brazilian Federal Government will offer a free training course on the subject, in addition to the campaign mascot calling attention to diagnosis and information on the subject.
Rare Diseases in China: Approval and Coverage of Orphan Drugs
In December of 2020, the National Security Health Administration has also updated its annual list of drugs that are covered under the Basic Medical Insurance Plan.
US FDA releases COVID-19 vaccine guidance
The United States Food and Drug Administration (USFDA) recently released a guidance for COVID-19 vaccine demonstrating at least 50% effectiveness in a placebo-controlled trial.
EMA waives fees for orphan drug consultations
European Medicines agency (EMA) updates their executive decision for orphan drug development of waiving fees for academic organizations.