New IMPD Guideline on the Requirements for Quality Documentation concerning Biological Investigational Medicinal Products in Clinical Trials
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.
Quality documentation concerning biological investigational medicinal products in clinical trials
In May the European Commission published the Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials. It addresses the specific documentation requirements with regard to biological, chemical andpharmaceutical quality of IMPs containing biological / biotechnology derived substances. Get the details.
Development and Manufacturing of APIs: Final ICH Q11 Document Published!
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.
Which Information on Stability of Pharmaceutical Bulk Products is required in the Application Dossier?
Bulk products used in the manufacturing of medicinal products are subject to the same GMP regulations as APIs and finished products regarding storage and transport. The respective guidelines only provide unclear information about the data required for the application dossiers. The EMA has now closed this loophole with the publication of a Questions and Answers document. Read more.
EMA strengthens Oversight on Clinical Trials outside EU
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.
How to Implement Design Control for Combination Products within Pharma?
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.
Transitional Regulations for the New Pharmacovigilance Package: Commission's Q&A Document provides Clarity
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.
CHMP adopts Guideline on Quality Aspects on the Isolation of Candidate Influenza Vaccine Viruses
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.
EU Commission publishes a New Document about Duplicate Marketing Authorisation Applications
In certain cases, it may be economically and practically interesting to possess several authorisations for one and the same medicinal product. The conditions for such an exceptional situation are explained in a document published by the EU Commission. Read more here.