News Archive

PIC/S - Publication of revised PIC/S Annex 1

28th September 2022

Publication of revised PIC/S Annex 1 The revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products has been published and will enter into force on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. The date of entry into operation is aligned with that of the revised EU Annex 1, which is identical to PIC/S Annex 1 (with some very minor editorial differences).

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EDQM - Call for experts: join the Ph. Eur. network

14th September 2022

EDQM - Call for experts: join the Ph. Eur. network

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EMA - Event Summary

14th September 2022

EMA - Event Summary on Workshop on the guidance on the protection of personal data and commercially confidential information (CCI) in documents submitted or uploaded via CTIS

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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 September 2022

14th September 2022

EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 September 2022

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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022

14th September 2022

EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022

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FDA - Computer Software Assurance for Production and Quality System Software

14th September 2022

Draft Guidance has been released on Computer Software Assurance for Production and Quality System Software.

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MHRA - new conflicts of interest code of practice for independent advisors

14th September 2022

MHRA - new conflicts of interest code of practice for independent advisors

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MHRA - Guidance on Medical devices: software applications (apps)

14th September 2022

MHRA - Guidance on Medical devices: software applications (apps). Added - 'Appendix 4 – Field Safety Warnings and End-of-Life notification'

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MHRA - Summary of responses to consultation - new Code of Practice for the Expert Advisory Committees

14th September 2022

MHRA - Summary of responses to consultation - new Code of Practice for the Expert Advisory Committees

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EMA - Comments received on ICH guideline Q14 on analytical procedure development

8th September 2022

EMA have published an overview of comments received on ICH guideline Q14 on analytical procedure development

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