News Archive

EMA - biosimilar medicines approved in the European Union (EU) are interchangeable

28th September 2022

EMA 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.

Read More+

FDA - Answers to GCP Questions

28th September 2022

FDA have published an Excel sheet of answers to some GCP questions.

Read More+

MHRA - Updated CAPA Guidance

28th September 2022

MHRA have updated the CAPA guidance PDF on 27th September.

Read More+

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).

Read More+

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

14th September 2022

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

Read More+

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

Read More+