FDA publishes current list of Drug Master Files (Type II)
Since the introduction of the Generic Drug User Fee Act (GDUFA) all Drug Master File (DMF) holders are required to pay a fee and the DMFs have to undergo a completeness assessment. The FDA has now published a list with all DMFs which meet these criteria. Read more.
New MHRA's Webpage on the Falsified Medicines Directive
The United Kingdom has established a webpage about the Directive on the prevention from falsified medicines ("Falsified Medicines Directive"). Read more here about the information contained on this page and learn why it is important to visit it.
European Pharmacopoeia Chapter 5.20 "Metal Catalysts or Metal Reagent Residues": Implementation Delayed Until Further Notice!
Ph. Eur. Chapter 5.20 on metallic impurities won't become legally binding until further notice. Read more about the background and the connection with the new ICH Q3D Guideline.
EMA publishes revised dossier-submission requirements for active-substance master files
The European Medicines Agency has updated its pre-authorisation procedural advice for users of the centralised procedure to reflect new requirements for the submission of active-substance-master-file (ASMF) dossiers as part of human or veterinary marketing-authorisation or variation applications. Go here to read more.
After a successful completed pilot phase, the ExcipactTM scheme will further expand as quality standard for GMP and GDP audits of manufacturers of pharmaceutical excipients. Read more here about the worldwide recognised audit scheme.
USP Elemental Impurities Implementation Advisory Group - Meeting Summary
The newly formed USP Elemental Impurites Implementation Advisory Group considers issues experienced by manufacturers of products especially affected by the elemental impurities standards. Read more about the output of the Group's last meeting.
The EDQM maintains a database that contains the relevant information about the Certificates of Suitability (CEP). Read more about the changes in the CEP database.
Updated Procedure for the Renewal and Revision of CEPs!
As of 1st September 2013, an updated procedure for the renewal and revision of CEPs will apply. By the end of July, the EDQM had already published the respective revised Guidelines and application forms. Read more here about the coming expectations for CEP holders.
New EMA Guideline on Starting Materials from Biological Medicinal Products
A new EMA Guideline clarifies the most important questions about the definition of starting materials and intermediates of biological medicinal products as well as the quality documentation of the marketing authorisation dossier. More details here.
Draft Guideline ICH Q3D for Elemental Impurities published!
The ICH Q3D Guideline on Elemental Impurities has just been published. This Guideline will have a major impact on both the pharmaceutical and the API industry and companies now have to make efforts to be prepared for the new provisions of the guideline. More details here.
Denying, Delaying, And Refusing: How to Fail a FDA Inspection
The FDA has published a new Draft Guidance on "Limiting an inspection" for comment. The document provides a detailed presentation of behaviours during a FDA inspection which may be seen as obstruction by the FDA inspectors. More details here.
Written Confirmation: A Questions & Answer Document of the Danish Authority provides further Clarifications
The regulation regarding the imports of APIs into the EU which must be accompanied by a Written Confirmation has been effective since 2 July 2013 and keeps on raising new specific questions. The DHMA (Danish Health and Medicines Authority) has recently published a Questions & Answers document. Read more here.