GMP News - Pharmaceutical Development / Clinical Trials / GCP

06.04.11

May unvalidated Methods also be accepted to test Drug Products? - The FDA answers

The use of validated analytical test methods in GMP regulated laboratories is obligatory. Nevertheless, under certain circumstances exceptions may be allowed. Here you can read FDA's answer to the question asked in the title of this news.

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06.04.11

New EMA Checklist should help Type IA Variation Submissions

The EMA has published a checklist which is supposed to help applicants to check the correctness and completeness of type IA variation notifications. This will be certainly a precious help for those who have to compile documents under time pressure. Read more here.

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06.04.11

EMA and FDA announce Pilot Program for Assessment of QbD Applications

EMA and FDA are launching a three-year pilot program that will allow parallel evaluation of relevant quality data components, known as Quality by Design (QbD), of selected applications that are submitted to both agencies at the same time. Read more.

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16.03.11

FDA: Applications to contain Information described by ICH Q8

As part of its Manual of Policies and Procedures, FDA's CDER has published a document called "Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review". Read more about the expectations.

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09.03.11

FDA and EMA Pilot Program for joint Review of QbD Components of new Drug Marketing Applications

The Food & Drug Administration (FDA) and the European Medicines Agency (EMA) will launch a collaborative Quality by Design (QbD) Application Review Pilot. Read more.

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01.03.11

EMA adjusts Fees for Marketing Authorisation Applications

From 1 April 2011 the EMA will charge new fees for its services in relation with marketing authorisations of medicinal products. Yet, fee reductions will be applied for marketing authorisations of orphan drugs, when specific criteria are met. Read more here.

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01.03.11

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.

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01.03.11

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.

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22.02.11

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

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17.02.11

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.

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02.02.11

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.

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19.01.11

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.

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12.01.11

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.

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05.01.11

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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15.12.10

What Information on Impurities is necessary for a Marketing Authorisation Application for a generic Medicinal Product in the US?

Recently the Food & Drug Administration (FDA) revised the Guidance for Industry "ANDAs: Impurities in Drug Products" and that way adjusted the regulations for generic medicinal products authorisation dossiers to the ICH Q3B(R2) regulations. Read more here.

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