GMP News - Regulatory Affairs

The final EMA Guidelines on the quality requirements for IMPs (pharmaceutical and biopharmaceutical drugs) have been released on the EMA website together with an overview of comments received on the draft guidelines published last year. Many of the comments related to the question "What is a Non-substantial Modification?".

A new version of the "Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008" was created in December 2021 and published on the HMA (Heads of Medicines Agencies) website.

As May 2022 approaches, the need for guidance on the In Vitro Diagnostics Regulation (IVDR) is growing. Regarding the topic of companion diagnostics, the EMA published a draft document at the end of last year about the consultation procedure between the EMA and a Notified Body.

The EMA HMPC has prepared a new question and answer on herbal medicinal products, which has been included in the practical guidance for marketing authorization holders on the subject of contamination by nitrosamines. Does a nitrosamine risk assessment also have to be carried out for herbal medicinal products?

In December 2021, the European Medicines Agency (EMA) published the draft guideline "Guideline on the acceptability of names for human medicinal products processed through the centralised procedure" for public comment on their website. 

The MHRA GVP inspectorate recently published the latest inspection metrics for the period from April 2020 to March 2021. All inspections in this period were conducted remotely. The largest number of findings in the reporting period related to quality management systems, followed by risk management, and ongoing safety evaluation.

In December 2021, the European Medicines Agency (EMA) published the updated and revised versions of the "Questions & Answers (Q&A)" documents related to centralised marketing authorization procedures on their website.