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News Archive
EMA - Consultation - concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems
28th November 2022EMA Consultation Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems.
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 2022EMA Consultation Draft guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy.
EMA - Consultation - reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances.
28th November 2022EMA 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.
ICH - The ICH E19 Introductory Training Presentation is now available on the ICH website
16th November 2022The ICH E19 Introductory Training Presentation is now available on the ICH website
MHRA - Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use
16th November 2022Several 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.
WHO - WHO releases first data on global vaccine market since COVID-19
16th November 2022This is the first report to capture the implications of COVID-19 for vaccine markets.
Access Consortium Good Manufacturing Practice (GMP) Statement
15th November 2022MHRA Notice Access Consortium Good Manufacturing Practice (GMP) Statement Published 15 November 2022
EMA - Human Medicines Highlights Newsletter
15th November 2022EMA - Human Medicines Highlights Newsletter, Issue 163 (Nov 22) released.
EMA - ICH Guideline and Template for Consultation
15th November 2022ICH M11 guideline (Step 2b), ICH M11 technical specification (Step 2b) and ICH M11 template (Step 2b) - open for consultation.
EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022
15th November 2022EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022
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