Regulatory News

Brexit: EU defines possible Solutions for Northern Ireland

The European Commission tries to find "creative solutions" for issues related to the implementation of the Protocol on Ireland and Northern Ireland.

More
Will the EU Concept of a Qualified Person spread the World?

PIC/S is planning to adapt EU GMP Annex 16 and has started a consultation/ adoption process.

More
Unexpected Deviations and the Role of the QP

Did you know that EMA's Questions and Answers Section to Annex 16 further clarifies the role of the QP in the context of handling unexpected deviations?

More
GMP: Are there "planned" Deviations?

One discussion we have again and again in seminars is the question of planned variations. But such terminology can lead to problems.

More
MHRA establishes own GMDP Database

The UK MHRA has established a new GMDP database with information issued by the MHRA and from EudraGMDP relating to manufacturing, wholesale authorisations and certificates and non-compliance statements.

More
Covid-19 Vaccine Mix-Up in the US - what's behind it?

It has been recently reported in the press that there was a mix-up in the manufacturing of the J&J Covid-19 vaccine at a contract manufacturer. Already one year before, considerable quality deficiencies were found at the site. Now the site had to stop producing for now.

More
UK Recognition of EU/EEA Batch Testing does not end on 1 January 2023

A letter from the UK government to medicines and medical products suppliers extends the transitional phase for the recognition of EU batch tests beyond 2022.

More
EU accepts MHRA inspections

The EMA has updated its Q&A document on the implementation of the Protocol on Ireland and Northern Ireland and clarified the recognition of inspections.

More
Brexit Guideline from CMDh updated

The Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh) of the HMA has updated a recently published Guideline on Brexit.

More
Updated Guidance on the Management of Clinical Trials during COVID-19

Pragmatic procedures are currently required to ensure the flexibility needed to maintain the integrity of clinical trials during the COVID-19 pandemic. The updated guidance on management of clinical trials during COVID-19 includes adapted approaches for IMP supply and details on remote source data verification.

More
x
Search