Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – March 2024

USA

FDA Final Guidance on Electronic Safety Report Submissions

The FDA has released three final guidance documents addressing electronic submissions for adverse event reporting. These cover IND safety reports, electronic Individual Case Safety Reports (ICSRs), and ICSR attachments submitted to the FAERS database, including expedited ICSRs from certain IND‑exempt studies.

OMUFA Facility Fees Increase by 23%

For FY 2024, the FDA announced a 23% increase in facility fees under the OTC Monograph Drug User Fee Program (OMUFA).

Guidance on Handling BA and BE Testing Samples

New FDA guidance clarifies retention requirements for bioavailability (BA) and bioequivalence (BE) testing samples by NDA applicants and CROs, addressing both test articles and reference standards.

Draft Guidance on Using RWD for Non‑Interventional Studies

The FDA has issued draft guidance on designing and analyzing non‑interventional studies using real‑world data (RWD) to support evaluations of safety and effectiveness for drugs and biologics.

Proposed Rule on “Demonstrably Difficult” Compounded Drugs

A new proposed rule outlines criteria for identifying drug products or product categories that present demonstrable difficulties for compounding. It also proposes three such categories for inclusion on the DDC lists.

Final Guidance on Controlled Correspondence for Generics

The FDA’s final guidance describes how generic drug manufacturers may submit controlled correspondence, how the FDA reviews and responds, and how to request clarification when needed.

Stakeholder Feedback on Advanced Manufacturing Guidance

Stakeholder comments on the FDA’s draft guidance for the Advanced Manufacturing Technologies (AMT) program highlight the need for more detailed information before industry fully adopts these approaches.

Updated Standards for Post‑Approval Safety Data

The FDA has adopted updated ICH guidance clarifying the use of new data sources—such as social media and patient support program data—in post‑approval safety reporting.

Updated Requirements for Exporting Investigational Drugs

The FDA has updated requirements for exporting investigational drugs. Exports must comply with the importing country’s laws and the FD&C Act section 802(f). Exporters must maintain records of all exported drugs and destinations.

FDA Endorses ICH Guidelines on Analytical Procedures

The FDA has endorsed two final ICH guidelines covering analytical procedure development and validation. ICH also announced revisions to guidance on residual solvents used in analytical methods.

Draft Guidance on Modernized Informed Consent

The FDA has issued draft guidance aligning informed consent recommendations with the 2017 revisions to the Common Rule, emphasizing the clear communication of essential trial information.

EUROPE

Proposed EU Legislation Shortens Data Protection by Six Months

The ENVI Committee supports new legislation granting up to 7.5 years of regulatory data protection for innovative medicines—six months less than the current eight‑year period for some products.

Guidance on Transitioning Clinical Trials to the CTR

Version 3 of the guidance document clarifies the process for transitioning clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation (EU) 536/2014. Starting 31 January 2025, only the CTR and its Delegated Acts will apply.

EMA Updates Explanatory Note on Fees

The EMA has updated its explanatory note on general fees, applying a 3.4% inflation adjustment to administrative and non‑administrative fees, rounded as applicable.

Updated Checklist for Type IA/IB Variations

EMA has revised the checklist for submitting full product information annexes for Type IA and IB variations (without linguistic review), confirming applicant responsibilities for SmPCs, labelling, PLs, and Annex A when applicable.

Updated Pharmacovigilance Assessment Sharing Template

EMA has released an updated template for assessors to communicate pharmacovigilance findings identified during marketing authorization or other lifecycle assessments.

AUSTRALIA

Guidance on Advertising Health Services Involving Therapeutic Goods

TGA’s revised guidance explains when health service advertisements may also be considered therapeutic goods advertisements and must comply with associated legislative requirements.

Updated CTN Form User Guide

TGA published version 1.3 of the CTN form user guide. All Australian clinical trials must have an Australian sponsor, which may be an individual, company, institution, or organization.

CROATIA

Updated Price List for Agency Services

HALMED has published a new price list for services such as registration and renewal, effective March 9, 2024.

DENMARK

New Side‑Effect Reporting Standard Implemented

With the EU’s E2B(R3) standard now in force, Denmark has launched a streamlined adverse event reporting platform that adapts based on user responses.

EGYPT

Draft Guidelines on Naming Human Pharmaceutical Products

Egypt has released draft guidelines replacing older letter‑count methods with advanced phonetic and orthographic similarity scoring using the EDA 4 Naming Checker Tool. The guidance aims to prevent look‑alike/sound‑alike naming risks.

IRELAND

Updated Guidance on Marketing Authorization Renewals

HPRA has published version 7 of its guidance on applying for renewal of national or mutual recognition procedure marketing authorizations, requiring use of the EU renewal application form.

MALAYSIA

Guideline for CTIL/CTX Applications

NPRA has issued updated guidance for applying for clinical trial import licenses (CTIL) and clinical trial exemptions (CTX), aligned with the CDCR 1984 and related legislation.

NEW ZEALAND

Updated Therapeutic Products Regulation Guideline

Medsafe’s updated pharmacovigilance guideline details sponsor responsibilities for monitoring medicine safety in New Zealand and includes best practice recommendations not currently mandated by law.

PAKISTAN

Guidelines on Labeling and Packaging of Pharmaceuticals

DRA has published guidance clarifying how mandatory information must appear on primary and secondary packaging under the Drug Labeling & Packing Rules 1976.

Guidelines on Patient Information Leaflets

New guidelines support the preparation of patient information leaflets (PILs) for new, generic, and biosimilar products, emphasizing clear, consistent, and patient‑friendly communication.

SINGAPORE

Points to Consider for Singapore Labelling

HSA has published updated labelling requirements. Labels must be in English, and any non‑English text must be certified as complete and accurate relative to the English version.

SOUTH AFRICA

Updated Guideline on Professional Information

SAHPRA has updated its guideline for professional information (PI) for human medicines, incorporating CHMP recommendations on reproductive and lactation risk.

Progress Reporting for Use of Unregistered Products

SAHPRA has released revision 3 of its progress report form for documenting patient use of unregistered medicines.