GMP News - Pharmaceutical Development / Clinical Trials / GCP

21.07.20

Regulatory Authorities worldwide work more closely together because of COVID-19

Regulatory authorities around the world want to work together more closely on the basis of Covid-19 and have identified three areas for this: research during pregnancy, medicines in clinical trials and monitoring of vaccines. Read more here.

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02.07.20

Impact of COVID-19 on EudraVigilance Reporting and Labeling

The European Commission, the HMA and the EMA released a Q&A document on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document includes flexible approaches for adverse reactions reporting and labeling.

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01.07.20

MHRA and FDA release Joint Paper on Data Integrity in Clinical Trials

GCP Inspectors from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US FDA have published a joint paper on data integrity in global clinical trials.

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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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