Regulatory News

Final Annex 21 published

The final version of Annex 21 to the EU GMP Guidelines ("Importation of medicinal products") was published in EudraLex Vol. 4. There were a few important additions and clarifications to the draft.

More
PIC/S revises GMP guide to reflect EU Clinical Trials Regulation

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised its GMP guide to reflect the EU Clinical Trials Regulation, which became applicable on 31 January 2022. In addition, a new PIC/S Annex 16 on the certification by the authorized person and batch release has been included.

More
Will the EU Concept of the QP spread the World?

The PIC/S has adopted the EU GMP Annex 16 and asks Member State authorities to implement it.

More
EU: Strengthening the EMA

A regulation strengthening the role of the EMA in crisis preparedness and management has been published in the Official Journal of the EU. The document also assigns several new tasks to the EMA.

More
Q&A Document on the QP Declaration revised

The CMDh has revised and published its Q&A document on the QP Declaration.

More
Brexit and Northern Ireland - what's new?

In the course of the Brexit negotiations, the role of Northern Ireland was always in focus. The aim of the EU in particular was to avoid a hard border on the island of Ireland. Now there are further announcements and publications.

More
Remote Inspections: Reflections on the global Transformation of international Inspections

The ICMRA has published a report on remote inspections with valuable advice for the pharmaceutical industry, also for its own preparation and implementation.

More
EU: Important Document for Inspections revised

The EU Commission has published a revision of the "Compilation of Union Procedures on Inspections and Exchange of Information". This is the eighteenth revision. It mainly involves editorial changes, a few adjustments and two new documents.

More
Northern Ireland: EU accommodates Great Britain

The European Commission has proposed further arrangements to respond to possible difficulties in the movement of goods between Northern Ireland and Great Britain

More
EU: further Extension of GMP and GDP Certificates

The EU will extend GMP and GDP certificates until the end of 2022 due to ongoing pandemic restrictions. The relevant document has been updated for this purpose.

More
x
Search