GMP News Drug Safety/Pharmacovigilance

26.01.22

Nitrosamines in Herbal Medicinal Products?

The EMA HMPC has prepared a new question and answer on herbal medicinal products, which has been included in the practical guidance for marketing authorization holders on the subject of contamination by nitrosamines. Does a nitrosamine risk assessment also have to be carried out for herbal medicinal products?

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25.01.22

Version 4.1 of the Q&As regarding the Clinical Trials Regulation

The European Commission published an updated version of the Questions & Answers document relating to the Clinical Trials Regulation (EU) No 536/2014. What documentation is required in the application for the authorization of a clinical trial relating to GMP for IMPs?

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25.01.22

Pharmacovigilance Inspections Report

The MHRA GVP inspectorate recently published the latest inspection metrics for the period from April 2020 to March 2021. All inspections in this period were conducted remotely. The largest number of findings in the reporting period related to quality management systems, followed by risk management, and ongoing safety evaluation.

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25.01.22

Safety Assessment of Clinical Trials

To ensure effective and efficient safety assessment of clinical trials, the EU Commission published rules and procedures for the cooperation of the Member States. The new Regulation will become applicable on 31 January 2022 - together with the Clinical Trials Regulation (EU) No 536/2014.

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25.01.22

CTIS - New Version of the Sponsor Handbook

The go-live date for the CTIS is 31 January 2022. In order to help sponsors prepare for using the CTIS, the EMA has now published a new version of the sponsor handbook.

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19.01.22

USP Proposal for Contaminant Pyrrolizidine Alkaloids

A new USP chapter <1567> on pyrrolizidine alkaloids (PAs) is being proposed. It discusses some analytical methods and existing challenges to measure PA contaminants in herbal medicinal products.

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19.01.22

Approved USP Chapters on Plastic Components used in Manufacturing

The new USP general chapters <665> and <1665> have now finally been approved. Chapter <665> establishes a baseline for the qualification of plastic components used in the manufacturing of pharmaceutical and / or biopharmaceutical drugs.

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18.01.22

EU Commission amends Delegated Regulation on Safety Features again

In order to ensure that medicinal products continue to be marketed with a unique identifier (UI) in Northern Ireland, Cyprus, Ireland and Malta, the Commission further extends the temporary derogation from the requirement to decommission UIs of products exported to UK.

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05.01.22

Canada is working on Technical Cannabis Standards

Canada will lead an ISO international IWG to develop three technical guidelines for Cannabis including one on Good Production Practices (GPP).

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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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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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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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24.11.21

HMPC adopts revised Quality Guidelines for Herbal Medicinal Products

EMA´s HMPC adopted the revised Guidelines on Quality and Specifications for herbal substances, herbal preparations and herbal medicinal products. Will a written GACP declaration for the herbal substance now become a requirement? 

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