USA
Content and Format of Composition Statements in NDAs and ANDAs
FDA issued draft guidance explaining how applicants preparing NDAs and ANDAs should develop composition statements and ensure that ingredient details are accurately reflected in product labeling.
Electronic Submission of Expedited Safety Reports for IND-Exempt BA/BE Studies
FDA published guidance outlining the electronic submission process for expedited Individual Case Safety Reports (ICSRs) from IND-exempt bioavailability (BA) and bioequivalence (BE) studies supporting ANDA applications through FAERS.
Regional Implementation Guide for E2B(R3) ICSRs
FDA released a Regional Implementation Guide describing technical requirements for electronic transmission of ICSRs and related attachments to CDER and CBER, including FDA-specific terminology and FAERS regional data elements beyond the ICH E2B(R3) guideline.
CDER Demonstration Program for Innovative Clinical Trials
FDA’s Center for Drug Evaluation and Research (CDER), through the newly established Center for Clinical Trial Innovation (C3TI), invited sponsors with eligible pre-IND or IND clinical studies to participate in a demonstration program. Up to nine projects will be selected to showcase innovative clinical trial designs and encourage broader adoption across therapeutic areas.
Evaluation of REMS Outcomes
Draft FDA guidance recommends that REMS included in NDAs, ANDAs, and BLAs establish well-defined objectives, measurable goals, and assessment methods to support effective implementation and future improvements.
Clinical Pharmacology Programs
FDA’s Office of Clinical Pharmacology (OCP) requested public feedback on policy areas that could strengthen clinical pharmacology programs supporting drug development.
Revised Draft Guidance on Biologics Promotion
FDA updated its draft guidance addressing labeling, advertising, and promotional communications for prescription biologics, including reference biologics, biosimilars, and interchangeable biosimilars.
Healthcare Competition Reporting Portal
The U.S. DOJ, HHS, and FTC introduced a public reporting portal that enables individuals to report suspected anticompetitive practices within the healthcare industry.
One-Page Prescription Drug Information
FDA confirmed that future patient prescription drug information is expected to be presented in a concise one-page format to improve understanding and reduce confusion.
Remote Regulatory Assessments (RRAs)
FDA provided additional clarification on the RRA process through revised draft guidance and stakeholder feedback.
Canada
Canadian Module 1 Guidance
Health Canada revised its guidance on the organization and placement of documents within Canadian Module 1, providing a structured format to help sponsors prepare regulatory submissions correctly.
EUROPE
Real-World Evidence
EMA published guidance describing the use of Real-World Evidence (RWE) in regulatory decision-making, including the use of real-world data and procedures for requesting related studies.
MAA Dossier Confidentiality
EMA issued guidance on identifying personal data and commercially confidential information in Marketing Authorization Application (MAA) dossiers submitted through national, decentralized, mutual recognition, and centralized procedures.
IRIS Guide for Applicants
EMA updated the IRIS Guide, explaining how applicants can prepare, submit, and manage scientific, regulatory, and lifecycle management applications through the IRIS platform.
GMP/GDP Questions and Answers
EMA revised its GMP and GDP Q&A guidance, including updates to Annex 8 on sampling requirements and considerations for excipients with potential DEG/EG contamination risks.
ICH Q3C (R9) Residual Solvents
EMA adopted a minor revision to ICH Q3C (R9), updating Section 3.4 with revised guidance on solvent volatility considerations in analytical methods.
Austria
Electronic Submission Regulation:
BASG released guidance explaining electronic submission requirements for human and veterinary medicinal product applications under national and MR/DC procedures.
France
Clinical Trial Authorization:
ANSM instructed sponsors of ongoing clinical trials authorized under Directive 2001/20/EC to complete the required transition process. Trials continuing beyond January 31, 2025 must be transferred to the CTIS platform in accordance with Regulation (EU) No. 536/2014.
Switzerland
GMP Compliance for Foreign Manufacturers
Swissmedic issued guidance clarifying GMP documentation requirements for foreign manufacturers submitting new marketing authorization applications and various post-approval changes.
ASIA
Malaysia
Malaysia – CTIL/CTX Guideline
NPRA updated the Malaysian CTIL and CTX guidance to incorporate revised safety reporting requirements and improve application and variation procedures.
Pakistan
Post Registration Variations
DRAP released the second edition of its Post Registration Variation Guidelines, detailing minor and major variation categories along with documentation requirements and review timelines.
Pakistan Single Window (PSW)
DRAP implemented the Pakistan Single Window system for processing Drug Import License applications and import release requests for donated medicines, enabling electronic submissions by license holders.
Saudi Arabia
Priority Review
SFDA updated Version 5.3 of its Priority Review Guidance by removing the first generic product criterion, revising the application form, and retaining the overall priority review framework.
