GMP News - Regulatory Affairs

02.02.23

Updated ICH E2B(R3) Q&As on ICRs

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.

more

02.02.23

Dosage versus Dose

The U.S. FDA published a draft guidance on the dosage and administration labeling section for certain medicinal products.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.

more

02.02.23

Format and Content of a REMS Document

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.

more

01.02.23

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.

more

01.02.23

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.

more

25.01.23

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.

more

25.01.23

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.

more

24.01.23

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.

more

24.01.23

EMA: IRIS Guides Revised Again

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.

more

24.01.23

CMDh: Q&A Document on ASMF Updated

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.

more

24.01.23

EMA revises Q&A Documents on the Topic of "Centralised Procedures"

In December 2022, the "Questions & Answers (Q&A)" documents relating to centralised marketing authorisation procedures were again revised and published on the website of the European Medicines Agency (EMA). The Q&A catalogues, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to possible questions at the different stages of the centralised marketing authorisation application process.

more

18.01.23

USP-NF Stimuli Article on Quality by Design (QbD) Principles in Method Development

In the Pharmacopeial Forum, PF 49(1), a stimuli article entitled "A Novel Approach Using Quality by Design to Develop and Implement Flexible Methods in Non-Application Over-the-Counter Monographs" was published.

more

18.01.23

Update on the EMA Checklists for Changes & Variations

The European Medicines Agency has published pre-submission checklists for certain procedure types. In particular the Validation Checklist for Type II (non)clinical variations has now been updated.

more

17.01.23

Clinical Trials: EMA clarifies Dates for the Transition Period

In order to help sponsors using the CTIS, the EMA has published a sponsor handbook. Following the previous update on how to manage clinical trials transitioned to the CTR, the EMA now clarifies the timelines for the transition period.

more

17.01.23

How to Manage Clinical Trials Transitioned to the CTR?

In order to help sponsors using the CTIS, the EMA has published a sponsor handbook. The EMA is continuously updating the CTIS Sponsor Handbook with further priority topics and a revised version 3 has now been published.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics