The EMA has recently published two documents concerning the centralised application procedures for new, generic and hybrid medicinal products. How useful these documents are and where to find them can be read here.
The second revision of the ICH document on Dissolution Testing for the comparability of pharmacopoeial texts in Europe, USA and Japan was published in June 2011 by the FDA. One of the aims of this guideline is to avoid redundant investigations by the pharmaceutical industry. Read more here.
Six updated chapters about AAS, IR and UV-Vis were published in the Pharmacopeial Forum from September 2011. The USP will replace the existing Chapter <851> with this group of topics. You will find more details here.
The Guideline "Stability Testing of existing active substances and related finished products" (CPMP/QWP/122/02 rev1 corr) provides information about stability data required in a marketing authorisation dossier for monographed and non-monographed APIs. As the obligations of the API manufacturers hadn't been very clear, the EDQM decided to provide clarification. Read more.
The FDA published a scientific poster on "Identifying faster Sterility tests for Biological Products - Regulatory Research Seeks to Reduce the Time Needed to Ensure the Safety of Critical Products". Read more.
In August, the FDA published a Strategic "Plan to Advancing Regulatory Science at FDA". This plan includes statements to amend microbial safety of products with modern microbiological methods. Read more.
Because of recent toxicological data, the detection and quantification of metal impurities in medicinal products and food supplements is of considerable importance. The methods described in the USP don't meet the current state of technology and are being revised. What changes can be expected in the new USP chapters <232> and <233> and what will be the consequences for the QC laboratories can be read here.
On 31 August 2011, the initiative SecurPharm - developed by the organisations BAH, BPI, VFA, Pro Generika, PHARGO, and ABDA - started. 270 specialists and managers from the pharmaceutical industry met at the Jahrhunderthalle in Frankfort. Read more here.
After the first five successful years of its existence, the European Qualified Person Association (EQPA) decided to develop a new structure and to integrate more colleagues into its activities. Read more.
On 12 July, the FDA withdrew the Guideline on "Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human Parenteral Drugs, Biological Products, and Medical Devices" from 1987. Read on.
The organisation and the regulations of the US Food & Drug Administration (FDA) are frequently considered hard to comprehend. With regard to medical devices the CDRH runs a quite detailed website. Read more.
In March 2011 the EDQM had invited experts from the pharma industry and water system suppliers to a workshop to discuss the possibilities for an approval of the membrane process for the manufacture of WFI in the European Pharmacopoeia. The report of the results is now available. Please read on here.