GMP News - Pharmaceutical Development / Clinical Trials / GCP

05.10.21

FDA´s Q&As on Generic Drug Development during the COVID-19 Pandemic

What can be done when a test or reference product batch used in the conduct of a bioequivalence study expires while the study is interrupted due to the COVID-19 pandemic? Find out in FDA´s updated Q&As on Generic Drug Development.

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05.10.21

Clinical Trial Information System - EMA publishes Sponsor Handbook

The go-live date for the CTIS is 31 January 2022. The System will then become the single entry point for clinical trial application submission, authorization and supervision in the EU. In order to help sponsors prepare for using the CTIS, the EMA has now published a handbook.

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05.10.21

Updated Version of the Q&As regarding the Clinical Trials Regulation

The European Commission published a revised Version 4 of the Questions & Answers relating to the Clinical Trials Regulation. In particular, updates to Q&As in Chapter 11 "Arrangements for the transitional period" have been made.

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22.09.21

New FDA Draft Guidance for Industry on Bioequivalence Studies

The FDA has published a draft guidance for industry entitled “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.” The document provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. The FDA recommends that in vivo BE studies are accompanied by in vitro dissolution profiles. Under certain circumstances, BE can be evaluated alone by using in vitro approaches (e.g., dissolution testing).

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16.09.21

Consultation on Amendments on Pharmacovigilance Activities

A targeted stakeholder consultation on amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities has been published on the EC website. The Regulation outlines the practical details on the performance of pharmacovigilance activities to be respected by MAHs, national competent authorities and the EMA.

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16.09.21

Signal Management: EMA and EC agree to further extend the Pilot

The EMA and the European Commission have agreed to further extend the pilot on signal detection in EudraVigilance by marketing authorization holders until the end of 2022. MAHs with APIs included in the EMA list of active substances and combinations involved in the pilot should continue to monitor them in EudraVigilance.

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08.09.21

ICH publishes Guideline Q13 on Continuous Production

End of July 2022, the ICH (International Council for Harmonisation) published the draft guideline on continuous manufacturing, which had been awaited for two years. In addition to batch definitions, the document describes three different continuous manufacturing approaches and provides guidance on control strategy and approval issues.

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01.09.21

EMA and FDA update Principles for Parallel Scientific Advice in the Marketing Authorization Process

Scientific advice and recommendations from regulatory authorities are usually of great benefit for specific medicines in the development phase. The principles for this have recently been updated by the U.S. and European regulatory authorities. Read here how parallel scientific advice from the EMA and the FDA works and what benefits it brings to the approval process.

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26.08.21

Clinical Trials: Application of the CTR confirmed as of 31 January 2022

It is official now: the EU Commission has confirmed the full functionality of the Clinical Trials Information System in the Official Journal of the EU. This means that the Clinical Trials Regulation 536/2014 (CTR) will become applicable on 31 January 2022. What are the GMP / GCP changes associated with this?

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26.08.21

What is Similarity?

The EMA published the final reflection paper on "Similarity". The paper shows how statistics should be used in drug development when a comparative assessment of quality attributes (QAs) needs to be made for pre- and post-manufacturing changes, biosimilar development as well as generics´ development.

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25.08.21

FDA Publishes New Near Infrared (NIR) Guidance

Near infrared (NIR) analytical procedures are widely used in the pharmaceutical industry for identification testing and assay measurements and for monitoring and controlling manufacturing processes. In this context, the U.S. Food and Drug Administration (FDA) has published a new Guidance for Industry entitled Development and Submission of Near Infrared Analytical Procedures.

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29.07.21

New WHO Draft on GMP for IMPs

Last year the WHO published draft documents on "Good manufacturing practices for investigational products" and "Good practices for research and development facilities". After consolidation of comments received and review of feedback, revised versions of the two guidelines have now been published for a second round of public consultation. Read more about WHO´s revised guideline on GMP for IMPs.

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29.07.21

EMA Drafts on Quality Requirements for IMPs

The EMA has published two draft guidelines on the quality requirements for IMPs (small and large molecules). According to the Agency, the documents are to be seen in connection with the Clinical Trials Regulation (EU) No. 536/2014 which is expected to become applicable in January 2022.

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29.07.21

New WHO Draft on GxP for Development

Last year the WHO published draft documents on "Good manufacturing practices for investigational products" and "Good practices for research and development facilities". After consolidation of comments received and review of feedback, revised versions of the two guidelines have now been published for a second round of public consultation. Read more about WHO´s revised guideline on GxP for Development.

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09.06.21

US Implementation of ICH Q12

The US FDA recently issued a draft guidance to help manufacturers implement ICH Q12 by explaining how to submit ECs. In addition, the agency provides general guidance about the elements that are considered ECs for the device constituent part of combination products.

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