At its meeting in Seville in November 2011, the ICH Quality Implementation Working Group finalised three Points to Consider topics. Please find more about the new document which has been published on 6 December here.
Very soon third countries will only be allowed to export Active Pharmaceutical Ingredients (APIs) to the EU if an accompanying letter confirms that the exporting country fulfils certain requirements with regard to GMP regulations. This written statement is not necessary if the specific country was evaluated positively by the EU Commission before. Learn more about the first steps towards a new regulation which will become effective on 2 July 2013.
The FDA published a Draft Guidance for Industry about the Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components. Read more.
The concept paper of the European Commission on safety features for medicinal products presents many questions to the stakeholders about the practical implementation. The deadline for comments is 27 April 2012. Read more here.
The EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended and withdrawn a number of Certificate of Suitability (CEP) between September and November 2011. Please read more here.
"Your firm has not thoroughly investigated the failure of a batch" - This is the most frequently cited criticism in the Warning Letters the US FDA issued to drug manufacturers in and outside the US in the Fiscal Year 2011. To get more information about the first results of the Warning Letters analysis that is annually published by Concept Heidelberg, please go here.
A further step has been made to fight against counterfeit medicine. Twelve countries have paved the way for the implementation of the Medicrime Convention by signing the first international treaty on October 28th. Please read more here.
To streamline the procedure for recall classifications and to save time and resources, FDA's CBER published the Direct Recall Classification Program for Blood and Plasma (DRC). More details can be found here.
In October, the European Medicines Agency published a new Concept Paper which has been developed by the Safety Working Group together with the GMP/GDP Inspectors Working Group. The document focuses on the establishment of an harmonised risk identification with toxicological data. Read more.
Following a draft which was issued in July 2009, the FDA developed and published the final Guideline on Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Forms in October 2011. Read more here.
To find out what the European pharma industry thinks about the announced revision of the Process Validation Note for Guidance by the European Medicines Agency, the European Compliance Academy (ECA) together with Concept Heidelberg conducted a survey in September 2011. Read more here.