ASIA
Pakistan
DRAP has advised users of the Med Safety App to install the latest update, which introduces new features and fixes and enables Pakistan’s National Pharmacovigilance Centre to request additional case‑specific information. DRAP also notified pharmaceutical and biological manufacturers and importers that all registration holders must update finished product specifications and validated testing procedures in PIRIMS within 30 days of notice publication.
Malaysia
NPRA has introduced a standardized template in its QUEST system for declaring the worldwide registration status of generic medicines. The template applies to all new applications for prescription generic products and supports multiple product entries. It follows earlier updates on uploading bioequivalence reports and API information requirements. NPRA also issued forms for Clinical Trial Import License and Clinical Trial Exemption (CTX) applications.
Philippines
The FDA has released guidance on regulatory reliance for clinical trials, allowing developers to use assessments from designated reference regulatory agencies (RDRAs) such as EMA and FDA. Under this pathway, certain multi‑regional clinical trials may be reviewed through an abridged procedure.
Indonesia
Indonesia issued the fourth amendment to Regulation 24/2017, updating requirements and documentation for variation submissions listed in Appendix XVI.
Japan
PMDA published precautions for handling sustained‑release formulations, highlighting risks associated with crushing and the importance of prescribing system safeguards.
Singapore
HSA issued guidance on the special access route for the import and supply of unregistered therapeutic products to address unmet medical needs. Forms for named‑patient and buffer‑stock requests must be completed by authorized healthcare professionals in accordance with the Health Products Act.
EU
EMA Regulatory Science Progress
EMA’s mid‑term review of its Regulatory Science Strategy to 2025 highlights major advances in clinical trial modernization, real‑world data development and the launch of the EU Clinical Trials Information System (CTIS), as well as the Accelerating Clinical Trials initiative.
Fees and Administrative Updates
EMA issued revised rules under the Fee Regulation effective 1 April 2023, covering marketing authorization applications, variations, annual fees and inspections. A corresponding explanatory note outlines inflation‑adjusted fee increases.
Electronic Data in Clinical Trials
EMA finalized guidance on computerized systems and electronic data handling in clinical trials, replacing the earlier reflection paper and providing updated expectations for electronic data capture, integrity and system validation.
Raw Data Pilot Q&A
EMA released a Q&A to support its pilot program for reviewing raw clinical trial data in regulatory submissions to improve scientific assessment and clarify operational requirements.
EU GMP Annex 1 Implementation
With the updated Annex 1 for sterile manufacturing coming into effect, regulators expect manufacturers to demonstrate contamination control strategies and implement integrity testing such as PUPSIT. FDA will not enforce Annex 1 but will inspect for similar principles.
USA
ISO IDMP Standards
FDA finalized guidance on the use of ISO IDMP standards to enhance international alignment in medicinal product data exchange.
ICH S12 for Gene Therapy
ICH published the final S12 guideline outlining nonclinical requirements for gene therapy products.
Accelerated Approval Oncology Trials
FDA issued draft guidance advising that randomized controlled trials (RCTs) should be used rather than single‑arm trials for oncology products seeking accelerated approval. Sponsors may use one RCT for both accelerated approval and confirmatory evidence or conduct parallel studies.
Pediatric Research Review Process
Draft guidance explains how FDA and HHS review pediatric research that IRBs cannot approve under standard criteria, including when elevated risk requires federal evaluation.
DSCSA Definitions Clarified
FDA finalized guidance defining “suspect” and “illegitimate” products under the Drug Supply Chain Security Act to support appropriate supply‑chain actions.
Electronic Systems and Signatures
Draft guidance provides FDA’s expectations for electronic systems, records, and signatures in clinical trials, including validation and data integrity considerations.
FDORA and Records‑Based Inspections
FDA may now rely on records review in place of some on‑site inspections under the Food and Drug Omnibus Reform Act (FDORA), potentially increasing inspection efficiency.
Potency Assays for Antiviral Antibodies
FDA released draft recommendations for developing potency assays across the lifecycle of monoclonal antibodies targeting viral proteins.
Digital Health Technologies for Trials
FDA will release new guidances and hold public meetings on the use of digital health technologies in clinical trials to address reliability, validation, and data quality concerns.
Pharmacogenomic Data Submissions
Draft guidance clarifies expectations for submitting pharmacogenomic data in INDs, NDAs and BLAs, replacing earlier 2005 guidance. Requirements vary depending on biomarker use and associated risks.
Dosage and Administration Labeling
Industry stakeholders requested more clarity on FDA’s expanded draft guidance for developing the Dosage and Administration section of labeling, which now emphasizes detailed instructions needed for safe and effective use.
Long‑Acting Local Anesthetics
FDA draft guidance supports development of long‑acting anesthetic formulations as part of efforts to reduce opioid use. New dosage forms aim to extend analgesia from hours to days.
Macular Degeneration Drug Trials>
FDA issued trial design recommendations for age‑related macular degeneration, encouraging double‑masked, parallel‑group RCTs powered for superiority or non‑inferiority against approved comparators.
