Warning Letter and Recall of a homeopathic Medicine for Children
FDA sends warning letter to the manufacturer of a homeopathic honey product, among other things because of microbiological contamination with Bacillus spec. Due to the advertised use for children, there was a not insignificant risk..
The EDQM (European Directorate for the Quality of Medicines & HealthCare) has adopted the document "Management of CEP guidelines and operational documents for the CEP procedure" by the end of 2022 and has now published it on its website. This document explains the new process for the development of supporting documentation related to CEPs (Certificate of Suitability of Monographs of the European Pharmacopoeia).
The updated ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process. The update includes a new Q&A regarding information about vaccine reporting.
The U.S. FDA published a draft guidance on the dosage and administration labeling section for certain medicinal products. The guidance is one of several FDA guidance documents addressing labeling for human prescription drugs.
The FDA published a guidance on the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drug products including a separate guide that contains a REMS Document Template.
Nitrosamine Impurities: EDQM completes General Monographs 2034 and 2619
The two pharmacopoeial monographs (2034) and (2619) have recently been revised. Read more about the requirements that manufacturers of APIs need to follow with regard to possible nitrosamine contamination in their products.
USP: Further Updates on "Residual Solvents" published for Comments
The USP chapter "<1467> RESIDUAL SOLVENTS-VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES" refers to the information provided in chapter <467 RESIDUAL SOLVENTS> and has thus now also been updated. The new draft has already been published on the website of the Pharmacopeial Forum of the USP and can be commented on until 31 March 2023.
USP: Possibility to Comment on the "Residual Solvents" Chapter
As recently reported, the "ICH guideline Q3C (R8) on impurities: guideline for residual solvents)" has been updated and can be consulted on the ICH website under the section "Quality Guidelines". As a result, the USP chapter "<467> Residual Solvents" has now been revised and published for comment on the USP Pharmacopeial Forum website.
EMA/CMDh: Update of the Q&A Document on Nitrosamines
The Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products", which was jointly prepared by the EMA and the CMDh, has been updated and the latest version published on the EMA website.
FDA: Updated ANDA PFC Document Published for Comment
In December 2022, the US-American FDA published the draft of the so-called document entitled "ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions" for comment. This is the second revision of the guidance document, which has been in place since 2017. It is now open for comment until 07 March 2023.
The "IRIS guide to registration and RPIs" was updated again between the end of November and mid-December 2022. The "IRIS guide for applicants" has also been revised and is now valid as version 2.13. The latest versions of both documents are available on the EMA website.
The CMDh, CMDv and EMA Q&A document "Q&A on Active Substance master file (ASMF)", last revised in March 2022, has been updated again and published on the HMA (Heads of Medicines Agencies) website in the CMDh section.