Pläne der EMA für die nächsten drei Jahre

Die europäische Arzneimittelagentur EMA hat eine neue Version des "3-year work plan for the Inspectors Working Group" für den Zeitraum Januar 2024 bis Dezember 2026 veröffentlicht. Erstellt wird der Plan von der GMDP Inspectors Working Group (GMDP IWG). Hierin finden sich auch z. T. erneuerte Zeitrahmen für die Überarbeitung von GMP-Vorgaben.

Kapitel 4 zur Dokumentation und der Anhang 11 (Computerised Systems) zu den EU-GMP Leitlinien, die ja auch zusammenhängen, sollen im ersten Quartal 2026 der EU Kommission als finaler Text vorliegen. So zumindest der Plan. Im gleichen Jahr, allerdings im vierten Quartal, sollen dann die spezifischen GMP-Leitlinien für die ATMPs überprüft werden, ob hier Änderungen nötig sind. Und auch an weiteren Anhängen soll es Änderungen geben (Anhang 3, Anhang 4, Anhang 5, Anhang 6, Anhang 15, Anhang 16). Für dieses Jahr (2024) sind allerdings keine weiteren Änderungen an Leitlinien geplant.

EMA-Pläne in der Übersicht

Folgend eine Übersicht der EMA-Pläne:

Dokument
Zeitrahmen
Geplante Änderung Zeitrahmen

GMP Guide: Chapter 4 (Documentation)

To provide the European Commission with a final text for the amended chapter in order to assure data integrity in the context of GMP. This would be in parallel with similar consideration of Annex 11 (Computerised Systems).
To work with GCP IWG, GLP IWG and PhV IWG on this topic.
Q1 2026

GMP Guide: Annex 11 (Computerised Systems)

To provide the European Commission with a final text for the amended annex in order to assure data integrity in the context of GMP. This would be in parallel with similar consideration of Chapter 4 (Documentation).
To work with GCP IWG, GLP IWG and PhV IWG on this topic
Q1 2026

Guidelines on GMP specific to ATMPS

Review the Guidelines in collaboration with CAT and the European Commission
following the publication of a new regulation on standards of quality and safety for substances of human origin intended for human application and need to update legal references and definitions.
Review the Guidelines in the light of new Annex 1 Manufacture of Sterile Medicinal Products and consider whether any updates are necessary.
Q4 2026

GMP Guide: Annex 3 Manufacture of Radiopharmaceuticals

To provide the European Commission with a final text for an amended Annex 3 following a review and update of the Annex to reflect current state of the art.
Q4 2026

GMP Guide: Annex 4 (Manufacture of Veterinary Medicinal Products Other Than Immunological Veterinary Medicinal Products)

To review comments received from concept paper stakeholder consultation and draft an updated text.
To provide the European Commission with a final text
Q1 2026

GMP Guide: Annex 5 (Manufacture of Immunological Veterinary Medicinal Products)

To review comments received from concept paper stakeholder consultation and draft an updated text.
To provide the European Commission with a final text.
Q1 2026
GMP Guide: Annex 6 Manufacture of Medicinal Gases To provide the European Commission with a final text for an amended Annex 6 following a review and update of the Annex to reflect current state of the art.
Q4 2026

GMP Guide: Annex 15 Qualification and Validation

To provide the European Commission with a final text for an amended Annex 15 in the context of new technology in facilities, products and processes and following
up on LLE recommendations, and extend the scope to APIs.
Q4 2025

GMP Guide: Annex 16 Certification by a Qualified Person and Batch Release

To provide the European Commission with a final text for an amended Annex 16 following up on LLE recommendations.
Q4 2025
GMP Guide: GMP for Novel Veterinary Medicinal Products To provide the European Commission with a final text.
Q4 2025

GMP Guide: GMP for Autogenous Veterinary Vaccines

To provide the European Commission with a final text Q4 2025

GMP and Marketing Authorisation Holders

To revise the paper in line with recommendations from the Nitrosamines LLE, to strengthen guidance for MAHs in terms of having adequate quality agreement with manufactures.
Q4 2025

ICH Q12: Lifecycle Management

To support the EU members of the Expert Working Group (EWG) in developing the training materials on the guideline with particular emphasis on GMP inspection and Pharmaceutical Quality System aspects, in liaison with PIC/S initiative. Q4 2025

Zurück zur Newsübersicht

Kontakt

Kontaktieren Sie uns

Haben Sie Fragen?

Concept Heidelberg GmbH
Rischerstraße 8
69123 Heidelberg

Tel. :+49622184440
Fax : +49 6221 84 44 84
E-Mail: info@concept-heidelberg.de

zum Kontaktformular

NEWSLETTER

Bleiben Sie informiert mit dem GMP Newsletter von Concept Heidelberg!

GMP Newsletter

Concept Heidelberg bietet verschieden GMP Newsletter die Sie auf Ihren Bedarf hin zusammenstellen können.

Hier können Sie sich kostenfrei registrieren.