USA
FDA Issues New Development Program Guidances
The FDA has released several guidance documents to support drug and device developers. These include recommendations for conducting drug–drug interaction studies involving therapeutic proteins, developing therapies for bladder pain syndrome, assessing immunotoxicity, and navigating interactions through the Q‑Submission program.
Draft Guidance Published on Preventive Migraine Therapies
A newly issued draft guidance expands the FDA’s recommendations for developing preventive migraine treatments and complements existing guidance focused on acute migraine therapies.
OSE 2022 Annual Report Shows Slight Increase in Adverse Events
CDER’s Office of Surveillance and Epidemiology reported a small rise in adverse event submissions—from 2.23 million in 2021 to 2.34 million in 2022. Reports included patient reactions, medication errors, and quality concerns.
Industry Reaction to Draft Decentralized Clinical Trials (DCT) Guidance
Stakeholders have responded to the FDA’s draft DCT guidance, acknowledging its strengths while raising questions about oversight of remote and in‑home trial activities.
FDA Proposes Replacing Medication Guides With PMI Sheets
The FDA has proposed requiring sponsors to develop a one‑page Prescription Medication Information (PMI) sheet written in clear, easily understandable language describing drug use, risks, and benefits.
Guidance on Using Generally Accepted Scientific Knowledge (GASK)
The FDA has clarified circumstances under which established scientific knowledge may be used to support parts of drug or biologic applications.
ICH Releases Draft Update to Good Clinical Practice (GCP)
The International Council for Harmonisation has issued a draft revision to its GCP guideline aimed at enhancing global acceptance of clinical trial data.
Renewed Efforts Toward Reciprocal Regulatory Approvals
U.S. lawmakers are revisiting proposals that would enable automatic U.S. approval of products already cleared by trusted foreign regulators.
FDA Publishes New and Updated Product‑Specific Guidances
The FDA has issued 25 new product‑specific guidances and updated 21 others to help generic drug developers demonstrate therapeutic equivalence in ANDA submissions.
Draft Guidances Released to Support Pediatric Drug Development
Two new draft guidances are intended to reduce delays between adult and pediatric approvals by clarifying expectations for pediatric development pathways.
Updated Labeling Required for ADHD Stimulants
Manufacturers of amphetamine and methylphenidate products must update labels to better communicate the risks of misuse, abuse, and other safety concerns.
FDA Requests Feedback on AI/ML in Drug Development
A discussion paper invites feedback on appropriate applications of AI and machine learning in drug development and combination products.
MDSAP Publishes Quality Management System Implementation Plan
A new document outlines how the Medical Device Single Audit Program will implement updates to its QMS guidance to strengthen overall quality practices.
Final Guidance Released on PDUFA VII Fee Program
The FDA has finalized guidance outlining updates to the Prescription Drug User Fee Act (PDUFA VII), including details on fee structures and program changes.
FDA Updates Manual on Bioequivalence Studies Using Clinical Endpoints
The agency has revised its MAPP to reflect current processes related to bioequivalence studies requiring clinical endpoints.
FDA Adopts Updated ICH Guideline on Quality Risk Management
The FDA has adopted the revised ICH quality risk‑management guideline, offering expanded recommendations for decision‑making and improving consistency.
Draft Guidance on Decentralized Clinical Trials
The FDA’s long‑awaited draft guidance provides clarity on conducting clinical trials that take place partly or entirely outside traditional trial sites.
EUROPE
EU Pilots Real‑Time Electronic Product Information (ePI)
The EMA and three national regulators have launched a one‑year pilot to test real‑time electronic product information for human medicines.
EMA Issues 10‑Point Drug Shortage Prevention Plan
The EMA has released guidance requiring MAHs, manufacturers, distributors, and wholesalers to implement shortage‑prevention plans tailored to their supply‑chain role.
EMA Invites Public Comment on Updated Transparency Framework
The EMA has opened consultation on proposed updates to rules governing clinical data transparency, including safeguards for confidential and personal information.
MHRA to Recognize Approvals from Seven Trusted Regulators
Beginning Q1 2024, the MHRA will implement an international recognition framework to streamline approvals for products already authorized by selected global regulators.
EMA Clarifies Diagnostic Certification Requirements for Combination Products
EMA officials clarified that drug approvals will not be delayed even if the associated diagnostic has not yet received CE certification.
ASIA
India
Mandatory Testing for Exported Cough Syrups
India now requires a Certificate of Analysis for all cough syrups intended for export, following global safety incidents involving EG and DEG contamination.
Pakistan
Guidance for Registering Products with Multiple Strengths and Volumes
DRAP has released guidance for submitting applications using Form 5F for products marketed in various strengths and fill volumes.
Updated Requirements for Contract Manufacturing Permission Extensions
DRAP has revised documentation requirements for extensions of contract manufacturing permissions when CTD dossiers have already been approved.
Draft Guidelines for Post‑Registration Variations
DRAP has invited stakeholder feedback on updated guidance describing variation categories, required documentation, and processing steps.
Philippines
Updated LTO Application Procedures for Health Product Establishments
The Philippine FDA is modernizing its online licensing systems and seeking stakeholder input through public consultations.
Sri Lanka
NME Pathway Requirement for New Molecular Entity Formulations
Local manufacturers must first secure approval through the NME Part 1 Pathway before submitting applications involving new molecular entities.
Singapore
Updated Guidance on Therapeutic Product Registration
HSA has issued updated guidance outlining submission, variation, and processing requirements for registering therapeutic products.
Updated CTD/ACTD Checklists and MIV Requirements
Revised checklists for NDA, GDA, MAV, and MIV submissions now include self‑assessment tools to support appropriate variation selection.
Updated PRISM Submission Guidance
Updates to Appendix 17 clarify processes for new product submissions, variation applications, responding to HSA queries, and withdrawing pending applications.
