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News Archive
EC - Adoption of revised Annex VI to Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR)
28th September 2022The European Commission (EC) have adopted the revised Annex VI to Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR)
EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022
28th September 2022EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022
EMA - Veterinary Medicines Regulation Highlights.
28th September 2022The latest edition of the Veterinary Medicines Regulation Highlights.
EMA - biosimilar medicines approved in the European Union (EU) are interchangeable
28th September 2022EMA and the Heads of Medicines Agencies (HMA) have issued a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.
FDA - Answers to GCP Questions
28th September 2022FDA have published an Excel sheet of answers to some GCP questions.
MHRA - Updated CAPA Guidance
28th September 2022MHRA have updated the CAPA guidance PDF on 27th September.
PIC/S - Publication of revised PIC/S Annex 1
28th September 2022Publication 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).
EDQM - Call for experts: join the Ph. Eur. network
14th September 2022EDQM - Call for experts: join the Ph. Eur. network
EMA - Event Summary
14th September 2022EMA - 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
EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 September 2022
14th September 2022EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 September 2022
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