GMP News - Regulatory Affairs

25.01.22

EMA: Updates of the Q&A Documents for "Centralised Procedures"

In December 2021, the European Medicines Agency (EMA) published the updated and revised versions of the "Questions & Answers (Q&A)" documents related to centralised marketing authorization procedures on their website.

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19.01.22

Q&A Document on the QP Declaration revised

The CMDh has revised and published its Q&A document on the QP Declaration.

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05.01.22

Brexit and Northern Ireland - what's new?

In the course of the Brexit negotiations, the role of Northern Ireland was always in focus. The aim of the EU in particular was to avoid a hard border on the island of Ireland. Now there are further announcements and publications.

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22.12.21

Questions and Answers on Labelling Flexibilities for COVID-19 Vaccines

The EMA published an updated version of the Q&A document relating to labelling flexibilities for COVID-19 vaccines. Can a QR code replace the printed expiry date?

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21.12.21

COVID-19 Vaccines - Inspections under Emergency Approvals in the US

The GAO report details the number and frequency of FDA inspections of Covid-19 vaccine manufacturers and other biopharmaceutical manufacturers during the pandemic period.

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21.12.21

WHO publishes Guidance on Safe Production and Quality Control of Monoclonal Antibodies

In October, the WHO published a draft revision of the Guide for the Safe Production and Quality Control of Monoclonal Antibodies. It is a continuation of the guidance documents on this topic that have already existed since 1991.

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21.12.21

Regenerative Medicine Advanced Therapy (RMAT)- FDA explains which products fall under "RMAT"

By providing clarification on the designation "Regenerative Medicine Advanced Therapy" , the FDA is providing more clarity on which products may fall in this classification.

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16.12.21

Update on ICH E6(R3) Progress

The E6(R3) EWG is currently working on ICH´s Guideline on Good Clinical Practice to address the application of GCP principles to the increasingly diverse trial types and data sources. To update international parties on the EWG’s progress ICH hosted a web conference in May. 

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16.12.21

Final ICH E8(R1) Guideline on General Considerations for Clinical Trials

The final ICH E8(R1) guideline reached Step 4 of the ICH Process. It provides guidance on the clinical development lifecycle, including designing quality into clinical studies. The next step in the ICH process is to implement the final guidance in ICH member countries.

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16.12.21

Good Lay Summary Practice

The Clinical Trials Regulation (CTR) requires in Article 37 that the sponsor of a clinical trial must submit a lay summary. The European Commission has now published a guideline on "Good Lay Summary Practice" (GLSP).

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15.12.21

Herbal Reference Standards - What are Active and Analytical Markers?

Active and analytical markers are used  for release and stability testing of herbal substances, preparations and HMPs. The EMA provides guidance on the selection of markers in a reflection paper on markers used for quantitative and qualitative analysis.

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15.12.21

CEPs: New IT Application of the EDQM

In October 2021, the EDQM established a new IT application for handling and managing CEP applications. This resulted in some innovations and changes, especially in the communication between the applicant and the EDQM. This in turn led to updates in the related documents and guidelines.

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08.12.21

HMPC starts Revision of GACP Guideline

The EMA committee adopted a concept paper for the revision of the Guideline on Good Agricultural and Collection Practice (GACP). Interested parties are invited to provide comments by 15 March 2022. 

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08.12.21

Q&As from the EMA Webinar for Industry on Integration of EudraGMDP and OMS

At the beginning of October, we reported on important changes for entries in the EudraGMDP Database. To inform about the new developments, the EMA had organized a webinar for industry on the integration of EudraGMDP and OMS. The EMA has now published a 13-page Q&A document with 87 questions raised during that webinar.

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07.12.21

How to use Real-World Data for Benefit-Risk Assessment

The EMA and the FDA recently issued a guidance on the use of real-world data for benefit-risk assessment. What is required for registry-based studies?

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