GMP News - Pharmaceutical Development / Clinical Trials / GCP


Concept Paper on the Revision of the GCP Directive published

The European Commission has published a Concept Paper on the revision of the GCP Directive 2001/20/EC. Both the contents of the directive and the transposition into national law now might be revised. Read more.



IMPD: EMA provides further Clarification for Quality of IMPs

The European Medicines Agency EMA has published a set of new Questions and Answers regarding the quality of Investigational Medicinal Products (IMPs). Read more.



Updated Q&A Document on the Submission of Variations published

The CMDh updates irregularly a Q&A document about the difficulties concerning the submission of variations applications and the classification of changes according to the new "Variations Regulation" (EC) 1234/2008. An updated Q&A document has been recently published. Read more here



The number of Warning Letters issued to Drug Companies and API Manufacturers increases

The number of Warning Letters the FDA issued to drug companies and API manufacturers last year has heavily increased. Some European companies are to be found among the addressees. A systematic analysis shows that most of the frequent deviations have been the same since four years. Read more here.



Warning Letters Report 2010: Laboratory Controls and Analytical Methods again among Top Five GMP Deviations

The analysis of FDA's Warning Letters from fiscal year 2010 shows growing deviations in Laboratories. Unadapted analytical methods and missing documentation keep on increasing. Read more here.



ICH Q8, Q9 und Q10: new Q&A Document published

The ICH Quality Implementation Working Group (Q-IWG) has issued volume 4 of the ICH guideline Q8, Q9 and Q10 - Questions and Answers Document. Read more.



New FDA Guidance: Codevelopment of Investigational Drugs for Use in Combination

FDA's Center for Drug Evaluation and Research (CDER) has published a Guidance for Industry on the codevelopment of two or more novel  drugs to be used in combination to treat a disease or condition. Read more.



FDA issues Guidance on Public Comment Procedures at Advisory Committee Meetings

The FDA has issued a final guidance for people who wish to comment during the agency’s advisory committee meetings. Read more.


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