GMP News - Pharmaceutical Development / Clinical Trials / GCP

The new IMPD Guideline - which has been recently published by the EMA - describes the requirements for quality documentation concerning biotechnological investigational medicinal products and provides - among other things - statements about shelf-life extension. Get more here.

One year after the publication of the Draft Consensus Guideline ICH Q11 "Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)", the finalised document has been released. Read more here about the new guideline.

The European Medicines Agency (EMA) has published the final reflection paper concerning ethical and good clinical practice (GCP) aspects of clinical trials conducted outside of the European Union (EU)/European Economic Area (EEA). Read more.

The term "Design Control" was originally used only in the development and manufacture of medical devices. In the meantime "Design Control" became an important issue for the development of pharmaceutical drug products just as well. There are more and more requirements and requests from the regulatory authorities relating to "Design Control" for Combination Products. For people working in the pharmaceutical industry it is a challenge to transfer all these new terms to their existing and traditional development processes. Read more.

The new pharmacovigilance package and its regulations which are entering into force in April and respectively in July this year prompt questions - mainly regarding deadlines for renewal applications for medicinal products authorisations. The EU Commission has published a Q&A document to answer these questions and to clarify further ones (e.g. about the pharmacovigilance system master file). Read more here.

In the recently published EMA Reflection paper on IVR/IWR systems, an additional QP Declaration is introduced for managing expiry dates.  Read on here.

On July, CHMP adopted the Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture as a guidance for the use of cells to isolate the viruses, the needed conditions and the passage of the viruses. More can be found here.