Strengthening Innovation and Compliance Across Pharma, Medical China Regulatory and Cosmetics
China continues to advance its life sciences regulatory framework with a strong emphasis on balancing innovation and regulatory oversight. Recent updates issued by the National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE) introduce new clinical evaluation guidance for pharmaceuticals and enhanced technical standards for cosmetic ingredients. These measures signal a continued shift toward life cycle-based regulation, scientific consistency, and higher quality standards across regulated products.
Strengthening Innovation and Compliance Across Pharma, Medical China Regulatory and Cosmetics
China’s National Medical Products Administration (NMPA) has introduced major regulatory updates across pharmaceuticals, medical devices, and cosmetics, emphasizing innovation, lifecycle supervision, and strengthened technical standards. These changes reflect China’s push toward a more predictable, science‑driven regulatory environment that supports development while reinforcing compliance.
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.
China’s CMDE Drafts Guidelines for the Registration of Implantable Medical Devices
On January 2023, the CMDE issued Chinese regulators issue regulations for enterprises’ management of medical device safety, plus draft guidelines for the registration and review of implantable medical device batteries.
China’s NMPA issues more Technical Guidelines for Bioequivalence Studies
China’s NMPA issues four technical guidelines for bioequivalence studies of specific varieties
China’s NMPA Announces Good Practices for Review Timelines During the Drug Evaluation Process
China’s NMPA Announces Good Practice for Timing Termination and Restoration of Review in the Process of Drug Evaluation
China’s NMPA issues Notice on Technical Guidelines for Change Studies of Marketed Chemical Drugs
On November 8, 2022, the CDE issued a notice on “Questions and Answers for Dissolution Profile Studies ⟨Technical Guidelines for Pharmaceutical Change Studies of Marketed Chemical Drugs (Trial) ⟩”
CHINA’S NMPA NEW REQUIREMENTS FOR SODIUM HYALURONATE
On November, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.
China’s NMPA Announces Electronic versions of Drug & API Export Certificates (2022)
On December 2022, a new template Drug Export Sales Certificate has been launched, which conforms to the format recommended by the World Health Organization (WHO). Electronic certificates have the same effect as paper certificates.