Artificial intelligence (AI) is revolutionising industry, and the pharmaceutical sector is no exception. One might think AI reaches its limits when it comes to GMP. But there are promising possibilities.
The EMA has updated its Questions and Answers and discusses where and when "Chain of Contracts" are accepted and which principles should be adhered to.
The EMA has published new questions and answers on remote batch certification/ confirmation by the Qualified Person (QP). When allowed by the competent authority, clear expectations are defined.
The EU is phasing out the extraordinary regulatory flexibilities for medicines that were put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic. This includes regulatory procedures, manufacturing and importation of APIs and finished products and other requirements.
An EU Regulation laying down specific rules for medicinal products for human use for Northern Ireland has been published in the Official Journal of the EU. It mainly concerns importation into NI and safety features.
The MHRA has announced a "long-term solution" of the Windsor Framework for the supply of medicines into Northern Ireland, effective from January 1, 2025. One key issue concerns the packaging and labelling of medicinal products.
The Mutual Recognition Agreement (MRA) between the EU and the US will be extended to veterinary medicines. This was announced by the EU Commission in a press release.
If you are a non-EU based company exporting drug products into the EU, it is essential to understand the role of a QP. It's also helpful to understand all other EU-GMP requirements to be better prepared for inspections.
The EMA has published a Guidance for Industry on "Good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact". It provides ten recommendations for various stakeholders.
EMA has published a new version of the "3-year work plan for the Quality domain". This also includes partly renewed timeframes for the revision of GMP specifications.
