May 17, 2024 BioPharma - Regulatory


Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling.”  This guidance is intended to assist new drug application (NDA) and abbreviated new drug application (ANDA) applicants in submitting an accurate and complete composition statement in their applications and corresponding statement of ingredients in the labeling, when applicable.

Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies

This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies conducted to support abbreviated new drug applications (ANDAs)2 to FDA Adverse Event Reporting System (FAERS).

Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products

This technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA or Agency). This document describes FDA’s technical approach for submitting ICSRs, for incorporating its regionally controlled terminology, and for adding FDA Adverse Event Reporting System (FAERS) regional data elements that are not addressed in the International Conference on Harmonisation’s (ICH) E2B (R3) Implementation Guideline (IG).

CDER Seeks Innovative Clinical Trial Designs for Demo Project

A new CDER sub-center is looking for drug developers with specific in-process studies for a demonstration program intended to boost innovation in clinical trial design. The Center for Clinical Trial Innovation (C3TI), activated on April 15, will choose up to nine sponsors with innovative clinical trials currently under a pre-Investigative New Drug or IND designation with CDER. The trials must be intended to support new drug product approvals or changes to approved drug product labeling. The goal is to use these projects as case examples that can be shared both within and outside the FDA to help foster innovation across all therapeutic areas.

Evaluation of REMS Outcomes to be Baked Into Applications

NDAs, ANDAs and BLAs need to incorporate risk evaluation and mitigation strategies (REMS) with clear goals, objectives, and strategies that align with the intended outcomes not only for the design of the REMS but also for future modification, a new FDA draft guidance says.

FDA OCP Seeks Public Input on Drug Development Clinical Pharmacology Programs

The FDA is soliciting input from interested parties on policy topics the CDER Office of Clinical Pharmacology (OCP) could develop and implement to support drug development programs.

FDA Advice on Labeling, Advertising Biologics Updated in Revised Draft Guidance

Answers to questions biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars have been issued by the FDA in a revised draft guidance.

New Portal Allows Public to Report Anticompetitive Healthcare Practices

The Department of Justice (DOJ), HHS and the FTC have jointly launched a public-facing portal for reporting unfair and anticompetitive practices that the Biden administration says will support its efforts to lower healthcare and prescription drug costs. This “one-stop shop to report potential violations of our competition laws to the Justice Department and FTC – will allow the agencies to collaborate early and often,” the DOJ said in a statement.

CDER Confirms Prescription Med Info Will Be One-Page

Yet-to-be-finalized, a proposed FDA rule to update and condense prescription medication guides for consumers, will replace current prescription info that the agency says is confusing, repetitive and conflicting — potentially resulting in patients taking medications incorrectly.

RRAs Beneficial, But Need More Explanation

The FDA questioned and answered virtually all aspects of Remote Regulatory Assessments (RRA) in an 18-page revised draft guidance issued last January, and the comments on the Q&A document have arrived with more questions of their own.



Organization and document placement for Canadian module 1

Health Canada has updated the organization and document placement for Canadian module 1 to reflect recent changes. This document contains a table outlining the Canadian module 1 sections and subfolders, with a list of possible documents. Sponsors must use this table to determine where to put documents provided as part of a regulatory transaction to Health Canada.



Real-world evidence

EMA published Real-world evidence. This document briefly describes how RWE, derived from the analysis of RWD, can be useful in the context of regulatory decision-making, the types of studies that can be performed and how EMA can help identify the best resources to address a research question. The process for requesting RWD studies is also explained.

Identification of personal data and commercially confidential information within the structure of the marketing authorisation application  (MAA) dossier

This guidance document is intended to apply to information/documents on medicinal products for human use, for which the procedure has been finalised under the national, mutual recognition, decentralised and centralised procedures. By extension, it is also intended to cover documents concerning the variation of the MA or documents containing information pertaining to the MAA dossier or documents linked to the aforementioned applications.

IRIS guide for applicants

EMA updated IRIS guide for applicants. This guide has been produced to show applicants how to use the IRIS platform to prepare, submit and manage an application and/or data for a scientific procedure (orphan designation application, scientific advice, ITF briefing meeting requests, PRIME, marketing status reports, inspections and veterinary signal management) and related activities, or applications for Parallel Distribution procedures. This guide also describes how to use the IRIS platform for product lifecycle procedure management (variations and Art. 61(3) notifications under Directive 2001/83/EC, variations requiring assessment under Regulation 2019/6 and Marketing Authorisation transfer applications for human and veterinary medicinal products) (further in the document PLM) after the submission has been created by EMA based on Applicant’s electronic application form (eAF) and dossier submitted through the eSubmission Gateway or eSubmission Web Client.

Guidance on good manufacturing practice and good distribution practice: Questions and answers

EMA updated Guidance on good manufacturing practice and good distribution practice: Questions and answers. Supplementary requirements: Annex 8 – Sampling of starting and packaging materials: Glycerol and other excipients at high-risk of DEG/EG contamination has been updated in this guidance.

ICH Q3C (R9) Residual solvents – Scientific guideline

EMA updated step 5 in  ICH Q3C (R9) Residual solvents – Scientific guideline. Adoption of Minor revision to section 3.4. including consideration of solvent volatility for analytical methods, (section 3.4., page 4) by the Regulatory Members of the ICH Assembly under Step 4, following the ICH minor revision procedure were the changes updated.


Guide to the Electronic Submission Regulation

BASG published Guide to the Electronic Submission Regulation. This guide is aimed at applicants or holders of authorization/registration in the specified area. All applications (human and veterinary) must be submitted electronically to the BASG. This provision is mandatory for the purely national procedure and the MR/DC procedure.


Authorisation of clinical trials

ANSM ask applicants to complete, no later than May 3, 2024, form for each EC of which are promoter, authorized according to Directive 2001/20/EC, still in progress in France and not transitioned to Regulation No. 536/2014 relating to EC (REC) as of the date of receipt of this email. As a reminder, any EC which will have at least one site still active in France on January 31, 2025 must be subject to of a transition request on CTIS before this date.


GMP compliance by foreign manufacturers

Swissmedic published GMP compliance by foreign manufacturers.  The objective of this guidance document is to clarify which documents should be submitted within the framework of an authorisation application (new application) which are minor type IA/IAIN variations that can be notified after the event, which are minor type IB variations that must be notified in advance and which are major type II variations for a human medicinal product that has already been authorised, or for a new application or a variation with or without assessment of a veterinary medicinal product that has already been authorised, in order to demonstrate that the responsible person.




Directive Concerning Updating Malaysian Guideline For Application Of Clinical Trial Import License (CTIL) And Clinical Trial Exemption (CTX)

NPRA published Malaysian Guideline For Application Of Clinical Trial Import License (CTIL) And Clinical Trial Exemption (CTX) edition 7.1. The Malaysian Guideline for Application of Clinical Trial Import License (CTlL) and Clinical Trial Exemption (CTX), 8th Edition (March 2024) has been updated which involves merging Malaysian Guideline for Safety Reporting of Investigational Products to Malaysian Guideline for Application of Clinical Trial Import License (CTlL) and Clinical Trial Exemption (CTX) and improvement of the application process CTIL/CTX and variation applications.


Implementation of Post Registration Variation Guidelines for Pharmaceutical and Biological Products (2nd Edition)

The Drug Regulatory Authority of Pakistan (DRAP) has recently released the 2nd Edition of the Post Registration Variation Guidelines for pharmaceutical and biological drug products. These guidelines provide essential information for submitting post-registration variation applications by registration holders and marketing authorization holders of drug products. The guidelines distinguish between minor variations (MiV-N, MiV-PA) and major variations (MaV), with specific timelines for each type. Applicants are required to adhere to the prescribed “Form” and documentation requirements when submitting variation applications.

Switching Over to Pakistan Single Window (PSW) for Drug Import License and Import Release of Donations Medicines

The Drug Regulatory Authority of Pakistan has switched over submission, processing and release order of Drug Import License and Import release of donation medicines on Pakistan Single Window (PSW). All Drug Manufacturing License (DML) holder companies are enabled o submit applications for all type of Drug Import License form March 05, 2024 through PSW System.

Saudi Arabia

Guidance for Priority Review of Product Registration

SFDA published Guidance for Priority Review of Product Registration version 5.3. Criteria for first generic is deleted and Application form is updated in this version. This document provides criteria for designation and process of submission of priority review applications.