News Archive

EMA - New Quality Innovation Expert Group (QIG) supports medicine innovation

30th November 2022

EMA has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufacture, and quality control of medicines for the benefit of patients in the European Union (EU). These include, but are not limited to, new technologies, digitalisation, novel materials and novel devices, in line with the priorities highlighted in EMA’s Regulatory Science Strategy to 2025.

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ICH - Press Release: ICH Assembly Meeting, Incheon, Republic of Korea, November 2022

30th November 2022

ICH - Press Release: ICH Assembly Meeting, Incheon, Republic of Korea, November 2022

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MHRA - Consultation to help influence how MHRA communicate with you

30th November 2022

Consultation with healthcare professionals: please complete our consultation to help influence how MHRA communicate with you

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MHRA - Drug Safety Update November 22

30th November 2022

MHRA - Drug Safety Update for Nov 2022 updated.

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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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