The FDA has published a new guidance providing recommendations to industry on formal meetings between the FDA and sponsors or applicants. The guidance supersedes the "Guidance for Industry Formal Meetings With Sponsors and Applicants for PDUFA Products" published in February 2000. Read more.
On 2 March 2009, the Member States have approved the new Commission Directive amending regarding advanced therapy medicinal products, Annex I to Directive 2001/83/EC. The draft Directive was put to vote at a meeting of the Standing Committee on Medicinal Products for Human Use. Find more here.
As part of the "global tracer" project the Mannheim Business School at the University of Mannheim conducts a survey on risks in the supply chain of companies in the pharmaceutical and biotech industries. Get the details here.
Improvements in protein purification and molecular separation technology and the large number of donations which are pooled made it necessary to revise the "Guideline on Plasma Derived Medicinal Products" by the European Medicines Agency. Read more here.
The European Medicinces Agency (EMEA) has published a new Guideline on Replacement of the Rabbit Pyrogen Testing by an Alternative Testing for Plasma derived Medicinal Products to provide a possibility to cover detection gaps like fever inducing cytokines. Read more here.
In order to facilitate the implementation of the Q8/Q9/Q10 Guidelines, the ICH Experts have developed a series of Q&As. This document was finalised on March 11, 2009 and approved by the ICH Steering Committee under Step 4 on April 15, 2009. You will find more information here.
In their effort to shed light on the origins of contaminated heparin, the FDA inspected two Chinese manufacturers of active pharmaceutical ingredients. This resulted in two warning letters with alarming conclusions. Find the details here.
One of the most useful resources with regard to current GMP interpretation in Europe are the Questions and Answers published by the European Medicines Agency (EMEA). To find out more about recently issued Q&As on PAT, read on here.
The European Directorate for the Quality of Medicines and HealthCare (EDQM) announced the suspension of five CEPs on their webpage. All of the CEP owners are Chinese companies. Click here to read more.
The two new consultation papers published by EMEA as part of the new variations regulation describe the details of the various categories of variations as well as the handling of the procedures defined in the regulation. Read more here.
The topic Validation is not listed as a paragraph in the 21 CFR 210/211. Therefore the ECA´s Warning Letters Report 2008 didn't cover this subject. In the following validation findings are analysed for the fiscal year 2008. Read more.
On 11 March 2009 the EMEA issued a so-called concept paper. In this paper the authority explains the problems in impementing the ICH Guideline Q10 "Pharmaceutical Quality System" in European legislation und thus proposes a revision of the EC GMP Guide. Read on here.