US FDA: Draft on Data Integrity for BE/BA Studies published
At the beginning of April 2024, the draft document "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies" was published on the US FDA website and is now available for comment for 60 days. The document is intended to assist applicants and marketing authorisation holders in the area of data integrity for the clinical and bioanalytical part of bioequivalence and bioavailability studies.
Warning letter to South Korea - from process validation to analysis of starting and raw materials
At the beginning of April, the FDA published a Warning Letter to a manufacturer from South Korea. This contained a whole series of deficiencies, including a lack of validation of manufacturing processes and quality control measures, as well as a lack of testing of ingredients such as glycerine for the absence of ethylene and diethylene glycol.
Ethylene and Diethylene Testing - Warning Letter and Regulatory Activities
Since 2022, the series of Warning Letters, but also the activities of the authorities on the subject of testing for ethylene and diethylene glycol, has not stopped. The FDA recently published another Warning Letter.
ICH E2D(R1) Draft Guideline on Post-Approval Safety Data
The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the consultation period.
How to Notify the MHRA of Changes to the PV System
The MHRA published guidance updates on how to notify the MHRA about changes to the Pharmacovigilance (PV) system. The revisions came into effect on 11 May 2023 and have been updated on 17 November 2023.
EMA/FDA joint Q&As on Quality and GMP aspects of Breakthrough Therapy Applications
The FDA and the European Medicines Agency (EMA) published "EMA–FDA joint Q&As on Quality and GMP aspects" supporting quality development for FDA’s Breakthrough Therapy (BT) and EMA's Priority Medicines (PRIME) programs.
Improving Registration and Reporting Summary Results Information for Clinical Trials
The FDA is announcing a newly published report on the Clinical Trials Transformation Initiative (CTTI) prepared on the findings of a collaborative project with FDA to understand the barriers to timely, accurate and complete registration and reporting of summary results information for clinical trials. According to the report, the major challenge was a lack of understanding on the part of the Responsible Party regarding the types of trials that must be registered, when the trial should be registered and when and for which trials summary results information must be submitted.
Master Protocols for Drug and Biological Product Development
A new FDA guidance provides recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on the submission of documentation to support regulatory review. Commenting on the proposed guideline was open until 22 February 2024.
EMA/HMA/ECA: List of Active Substances defined to prevent supply bottlenecks
As part of the measurements against supply shortages in the pharmaceutical sector, the first version of the "Union list of critical medicines" and further information on this was published on the EMA website at the end of last year. This list contains more than 200 active substances that are considered critical in the event of a supply shortage and whose shortage must be avoided at all costs.
In January, the question and answer catalogue "RPM for PLM (Regulatory Procedure Management for the Product Lifecycle Management) - Frequently Asked Questions and Answers" was published on the EMA website. In addition to the glossary, it contains 23 questions and their answers relating to the use of the IRIS system.
FDA Revision to the Guidance on Quality Considerations for Ophthalmic Drug Products
Following recent cases of microbially contaminated ophthalmic drug products as well as safety recalls, the FDA published a revised draft guidance on Quality Attributes for Ophthalmic Drug Products, to include information about product sterility and preservative use. Moreover the revision clarifies that the guidance applies to all ophthalmic drugs, including over-the-counter (OTC) drugs and combination products.
Use of Digital Health Technologies (DHTs) to Acquire Data Remotely
Following the draft guideline published in March 2022 the FDA issued the final guidance that provides industry, investigators and others with recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical trials.
FDA Exception from the Requirement to obtain Informed Consent
The FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of trial participants. The rule provides an exception from the requirement to obtain informed consent when a clinical trial poses no more than minimal risk to the participants.
EMA recommends Suspension of Medicines following GCP Inspection of a CRO in India
Following a good clinical practice (GCP) inspection which showed irregularities in study data, the EMA has recommended the suspension of marketing authorizations of a number of generic medicines tested by a contract research organisation (CRO) located in India.