GMP News - Pharmaceutical Development / Clinical Trials / GCP

17.06.20

Remote GCP Inspections

The EMA released a new guidance explaining how remote Good Clinical Practice (GCP) inspections should be conducted during the COVID-19 pandemic.

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16.06.20

Follow-up activities after Pharmacovigilance Inspections

EMA´s Pharmacovigilance Inspectors Working Group adopted an new guideline on the follow-up activities of pharmacovigilance inspections.

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02.06.20

MHRA´s Expectations during GCP Inspections

The MHRA recently shared their expectations regarding electronic systems used in clinical trials and what they want to see during a GCP inspection.

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20.05.20

Update on COC / COP and Extractable Elements in Plastic Materials

Three drafts for new Ph. Eur. chapters on plastic packaging materials have been published for comment in the recent issue of Pharmeuropa: Cyclo-olefin polymers (COP), Cyclo-olefin copolymers (COC), and Extractable elements in plastic materials for pharmaceutical use.

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19.05.20

EMA clarifies Computer Validation and Data Integrity responsibilities in Clinical Trials

The EMA recently published a notice to sponsors which clarifies the responsibilities in regard to the qualification and validation of computer systems and data Integrity in clinical trials.

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29.04.20

New EU/EMA planned Actions in the Context of the COVID-19 Pandemic

The European Medicines Agency EMA has published three press releases on current EU/EMA activities in the context of the COVID-19 pandemic.

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27.02.20

ICH M9 BCS-based biowaivers and Q&A´s adopted

The ICH M9 Guideline and the corresponding Q&As reached Step 4 of the ICH Process in November 2019.

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27.02.20

QbD for TDS: FDA´s new draft guidance

The FDA published a draft guideline "Transdermal and Topical Delivery Systems - Product Development and Quality Considerations".

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18.02.20

Clinical Trials Regulation Questions & Answers Version 2.3

The European Commission (EC) published an updated Version 2.3 of the Questions & Answers relating to the Clinical Trials Regulation.

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18.02.20

Second Revision of FDA Guidance Microbiology Data for Systemic Antibacterial Drugs

FDA published the second revision of their Guidance for Industry "Microbiology Data for Systemic Antibacterial Drugs -Development, Analysis, and Presentation" to define the requirements on a overall microbiology development program for such products.

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18.02.20

FDA´s Advice for Sponsors of Adaptive Design Clinical Trials

The FDA published a new guideline on Adaptive Design Clinical Trials for Drugs and Biologics.

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18.02.20

ICH E9 Addendum adopted

The ICH E9(R1) Addendum to defining the appropriate Estimand for a Clinical Trial / Sensitivity Analyses reached Step 4 of the ICH Process.

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18.02.20

EMA/CHMP publishes new Q&A Document on Comparability Considerations for ATMPs

A document on the topic of comparability in the context of Changes and Variations at ATMP, published in December by the EMA, respectively the CAT, completes the series of guidelines and assistance around ATMP.

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17.02.20

Clinical Trials Regulation Questions & Answers Version 2.2

The European Commission (EC) published an updated Version 2.2 of the Questions & Answers relating to the Clinical Trials Regulation.

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17.02.20

Final Guideline on GCP for ATMPs published

The European Commission has now published the final Guideline GCP for ATMP as a further building block of its growing guidance package on  the requirements for Advanced Therapy Medicinal Products.

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