GMP News - Quality Assurance

For fiscal year 2022, the FDA's dashboard lists 168 inspections at pharmaceutical companies in the EU. What is the reason for this?

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

New and revised guidance documents and materials related to ePI (electronic Product Information) are now available on the EMA website under the heading "What's New in PLM?" in the PLM Portal (Product Lifecycle Management Portal).

Since beginning of September 2023, the CEP 2.0 is implemented by the EDQM (European Directorate for the Quality of Medicines & HealthCare). From now on, applicants of a new dossier or renewals will receive a CEP 2.0. This will be available as a PDF file in the so called sharing tool "DCEP" and will be signed electronically only.

In the beginning of September, the stimuli document "Proposed Definitions of Excipient Components- Revisions to 2018 Definitions- PF 49(5)" was published for comment on the website of the Pharmacopeial Forum of the USP. Comments on this draft can be submitted until 30 November 2023.

Once again, the "Frequently asked questions about parallel distribution" have been revised and published on the EMA website. The information provided by the EMA on parallel distribution of centrally authorised medicinal products is set out in the Q&A in six paragraphs.

The FDA published the final guidance on annual status reports and other submissions for postmarketing requirements (PMRs). The reports are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on PMRs and postmarketing commitments (PMCs) in a consistent format.