News Archive

MHRA Blog - Increasing the efficiency of your clinical trial authorisation (CTA) application and reducing the need for subsequent substantial amendments

30th November 2022

MHRA Blog Post - Increasing the efficiency of your clinical trial authorisation (CTA) application and reducing the need for subsequent substantial amendments

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UKRI - launch a new opportunity for Centres for Doctoral Training (CDTs) in artificial intelligence (AI)

30th November 2022

UKRI to launch AI CDT call.

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EMA - Consultation - concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems

28th November 2022

EMA Consultation Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems.

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EMA - Consultation - draft guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy

28th November 2022

EMA Consultation Draft guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy.

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EMA - Consultation - reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances.

28th November 2022

EMA Consultation The European Medicines Agency has published for public consultation a reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances.

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ICH - The ICH E19 Introductory Training Presentation is now available on the ICH website

16th November 2022

The ICH E19 Introductory Training Presentation is now available on the ICH website

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MHRA - Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use

16th November 2022

Several companies have contacted the MHRA regarding cannabis-based products for medicinal use. This blog provides information on what authorisations are required in order to MHRA Manufacturing Licence Application manufacture within this sector of the pharmaceutical industry.

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