International

The International Council for Harmonization (ICH) are preparing new guidelines for analytical methods used by manufacturers for testing medicines post approval. According to the feedback from ICH the purpose of this update is to simplify the process, encourage companies to update their analytical methods which may no longer be fit for purpose and provide guidance in areas where there is not any, for example in real time release testing.

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UK

MHRA released a new guidance on risk-based monitoring. While risk-based monitoring is not new to the industry it was not until COVID-19 epidemic that trigger the use of remote monitoring. It is a positive step from MHRA to reassure everyone working in the industry that remote monitoring is a valid method of monitoring. 

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As many people are aware the combined review is now the official way of submitting clinical trial applications, however there are some upcoming changes in regards of studies involving ionisation radiation and also combined drug-medical device clinical trials. We hope the new upgrades, when released, will streamline the submission process. Current process for drug-medical device clinical trials requires 2 separate submissions. 

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HRA have release new model agreements: Model Confidentiality Agreement (mCDA), Model Non-Interventional Study Agreement (mNISA) and Clinical Research Organisation mNISA (CRO-mNISA)

The templates are available in IRAS support section.

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USA

FDA have recommended sponsor to collect information regarding patients’ race and ethnicity and improve representation in clinical trials. 

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FDA have also released guidance on bioavailability data which will be required as part of investigational new drug (IND) applications, new drug applications (NDA) and NDA supplements. Generally, BA studies should be conducted in healthy volunteers under fasted conditions using the highest strength of the drug with an adequate washout period between treatments,” said Dakshina Chilukuri. “It is important that sponsors include adequate samples and sampling time points in the study design to achieve sufficient power for the analyses.

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