GMP News - Pharmaceutical Development / Clinical Trials / GCP

12.06.19

MHRA plans to apply AQbD principles

The MHRA plans to apply analytical quality by design principles, including the analytical target profile (ATP), to its pharmacopoeia (BP).

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29.05.19

Revised USP chapter <3> Topical and Transdermal Product Quality Tests

The revised USP general chapter <3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS - PRODUCT QUALITY TESTS has been approved.

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28.05.19

How to manage Safety Data in a blinded Trial?

The MHRA Inspectorate recently clarified the agency´s expectations regarding the unblinding and reporting of serious adverse reactions (SARs) associated with comparator drugs.

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28.05.19

FDA´s final REMS Guideline

The US FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy (REMS) plans and to making sure they do not impede generic drug development.

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15.05.19

How does the GDPR impact Clinical Trials?

The European Commission released a Question and Answers paper on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR).

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08.05.19

Q&As on Safety Features - Version 14

The European Commission published version 14 of the Q&A´s on Safety features for medicinal products for human use.

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04.04.19

Brexit: Importation of IMPs from approved countries in a no deal scenario

The MHRA recently provided guidance on how the management and oversight of the import of investigational medicinal products (IMPs) from listed countries will work in a no deal scenario.

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04.04.19

Monitoring of Clinical Investigations: FDA´s Q&As on Data Integrity

The FDA provided additional guidance on risk-based monitoring for effective oversight, including Data Integrity. Read more on FDA`s draft Guidance for Industry A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.

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21.03.19

FDA´s Pilot Program for Established Conditions

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced a new pilot program where sponsors can propose established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) or as a prior approval supplement (PAS).

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21.03.19

Is the review of the Audit Trail required in Clinical trials?

The MHRA recently provided guidance on Data Integrity in clinical trials. Is the review of the audit trail required?

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21.03.19

Short Format Development Safety Update Report

Not all trials are the same in terms of risk. Therefore, the MHRA proposesd a simpler and shorter form in lieu of a full Development Safety Update Report, giving a significant time saving.

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20.03.19

Focus on Cannabis in INCB´s Report for 2018

The International Narcotics Control Board (INCB) recently published its report for 2018 with a strong focus on cannabis. Read more about Cannabis and cannabinoids for medical, scientific and “recreational” use: risks and benefits.

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06.03.19

Brexit: Handling Pharmacovigilance Data from the UK

How should reports of adverse reactions from the UK be handled after the withdrawal date? New Q&As give a clear answer.

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26.02.19

MHRA Pharmacovigilance Inspection Metrics

The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2017 to March 2018. 

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20.02.19

EMA's Reflection Paper on the Qualification of Non-Genotoxic Impurities

Data from pre-clinical/clinical studies are often not sufficient for a comprehensive qualification of impurities with regard to their biological safety profile. The new EMA Reflection Paper provides guidance for determining the safety profile of impurities by means of various methods.

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