ICH: Revised ICH Q1 Draft for Consultation

On 11 December, the European Commission, the European Parliament, and the Council of the European Union reached a provisional agreement to update Europe's medicinal products regulatory framework.

The ICH’s Cell and Gene Therapy Discussion Group (CGTDG), which was established in May 2023, has provided recommendations with regard to future Advanced Therapy Medicinal Products (ATMPs) Related Guidelines.

EMA has updated its Q&A on biological medicinal products, addressing topics that previously required clarification or were subject to differing interpretation. The latest revision adds six new questions and updates several existing answers.

The integrity of a primary packaging system (container closure system) is essential to prevent product loss by leakage or evaporation and at the same time protect the product from contamination. The task of a primary packaging system (container closure system) is essentially to prevent the product from being lost (e.g. leakage, evaporation, etc.) and to prevent the product from being contaminated from the outside.