FDA issued 8 Warning Letters to Companies because of Missing Establishment Registration
Within 5 months, the FDA has issued 8 Warning Letters to companies who failed to comply with the obligation to register production establishments. Read more here.
FDA - S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
The US Food & Drug Administration (FDA) published two Guidances for Industry with regard to Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. Find more details here.
MHRA publishes GMP Deficiency Data Review April 2011 - March 2012
In April, the Medicines and Healthcare products Regulatory Agency (MHRA), UK, issued a review of the main GMP deficiencies for the period from April 2011 to March 2012. More details can be found here.
In its latest press release, the Pharmaceutical Inspection Co-operation Scheme PIC/S highlighted the outcome of its last Committee Meeting. What are the main news? Read more.
FDA starts Voluntary Audit Report Program for Medical Devices
On 5 June 2012, the FDA has begun a "voluntary program" for medical devices audits entitled "Medical Devices ISO 13485:2003 Voluntary Audit Report Submission Pilot Program" - based on ISO 13485:2003. The purpose is to extend FDA's inspection intervals. Read more.
Half-year Report 2012: FDA Medical Devices Warning Letter Statistics
We regularly analyse the Warning Letters issued by the FDA. The following information presents the current evolution of the Top 5 hit list - with regard to medical devices - for the first half of the fiscal year 2012 (from 1st October 2011 to 15 March 2012). Read more.
EMA: Practical Guidance on Implementation of Pharmacovigilance Legislation published
The European Medicines Agency has published a set of questions and answers concerning the initial phases of the operation of the new pharmacovigilance legislation. Read more.
The U.S. Food and Drug Administration FDA has issued its yearly list of planned draft and final guidance documents for 2012. There are about 50 such guidance documents planned. Read more.
Foundation of a new French Health Regulation Authority
The existing French health authority has been re-organised. The AFSSAPS has been replaced by the ANSM (Agence nationale de sécurité du médicament et des produits de santé). Read on.
EMA Reflection Paper on Sourcing Biological Starting Materials
According a new Reflection Paper, the European Medicines Agency (EMA) wants companies to trace their heparin supplies back to the slaughterhouse. Read more.
The Chinese Ministry of Health has published revised GMP rules for drugs in the beginning of 2011. March 1, 2011 was specified as date for the entry into force. Now, an English translation is available. Read more about the main differences between the Chinese GMP rules and EU GMP Guideline Part I.