GMP NEWS 2016

The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to current guidance on first-in-human clinical trials.

WHO's guideline for clinical research organisations performing in vivo bioequivalence studies has been extensively revised and recently published. Read more in the News about which requirements are now binding for CROs with regard to the QM system and electronic data management.

The US FDA implemented the updated Guidance for Industry Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components.

The EMA published the final "Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus" after the completion of the accepted comments of the public consultation.

The European Directorate for the Quality of Medicines & Healthcare (EDQM) published a survey to gather information from relevant stakeholders for elaboration of a chapter on microbiological control of tissues.

The World Health Organization (WHO) recently published a draft document on analytical method Validation for comment. Read more about the draft "Guidelines on Validation - Appendix 4 Analytical Method Validation".

In Pharmeuropa 28.3 revisions of two Ph. Eur. general chapters on containers (3.2.9 and 3.2.3)  have been published for comment. Deadline for comment is September 30, 2016. Read more about the drafts for 3.2.9 "Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders" and 3.2.3 "Sterile plastic containers for human blood and blood components".

In May 2016, the FDA published some revisions in the text of the Bacteriological Analytical Manual, Chapter 23, "Microbiological Methods for Cosmetics".

One and a half year after its publication, the ICH Q3D guideline still raises many questions. The EMA has recently published a guideline draft aiming at clarifying the practical implementation of ICH Q3D. Read more here about what is expected in a marketing authorisation application or in an application for a CEP with regard to risk assessment and the control of elemental impurities in APIs and medicinal products.