GMP News - Pharmaceutical Development / Clinical Trials / GCP


Clinical Trials: new Document for public Consultation

The European Commission has published a public consultation document: Draft revised version of detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use ('CT-3'). Read more. 



Clinical Trials: FDA proposes new Data Falsification Rule

The FDA proposed an updated regulation to require sponsors to report information pertaining to any individual that has or may have engaged in falsification of data in clinical trial studies involving human or animal subjects. Read more.



Regulation amending the REACH Annexes relevant for SDS (Safety Data Sheet)

The Commission has adopted a Regulation amending the REACH Annexes relevant for SDS – Annex II and, to a lesser extent, Annex VI. Click here to read more.



Revised Q&A Document available in EudraLex Volume 10 - Clinical Trials

The "Questions and Answers document" in the EudraLex volume 10 on clinical trials has been revised. The revised version 6.0 of this document is available here.



EMA publishes Reflection Paper on ethical and GCP Aspects of Clinical Trials conducted in third Countries

The European Medicines Agency has published for public consultation a reflection paper on ethical and GCP aspects of clinical trials conducted in third countries for evaluation in marketing authorisation applications for medicines for human use, submitted to the EMA. Read more.



Assessment of the Functioning of the 'Clinical Trials Directive' 2001/20/EC

Assessment of the Functioning of the 'Clinical Trials Directive' 2001/20/EC: summary of responses to the public consultation paper published. Read more.



FAQs on the EMA-FDA GCP Initiative published

The EMA and the FDA have published a set of Q&As on their new GCP-Initiative. Read more.



New FDA - NIH Initiative on a Formulations Framework for paediatric Drugs

A collaborative initiative between the FDA and the National Institute of Health is currently being developed to define a formulations framework for drugs that are used in pediatric patients. Read more.



Final Annex 13 on Investigational Medicinal Products Published

The European Commission has passed and published the final version of Annex 13 ("Investigational Medicinal Products") to the EC GMP Guide. The new Annex will come into force in July 2010. We have summarised the most important changes for you.



FDA Director of Pediatric International Program to speak at ECA Development Conference

Dr Jean Temeck, Director at the FDA Office of Pediatric Therapeutics has confirmed to speak at the 4th ECA Good Development Practice Conference on 18 - 20 May 2010 in Vienna. Read more.



FDA to speak at ECA Development Conference on Quality by Design

Dr Keith Webber, Deputy Director of the Office of Pharmaceutical Science, CDER, FDA has confirmed to present the FDA Point of View on Quality by Design - at the 4th ECA Good Development Practice Conference taking place from 18-20 May 2010. Read more.



European Medicines Agency develops European Network of Paediatric Research

The European Medicines Agency (EMA) is currently developing a European paediatric network called ENPREMA and has defined criteria which will have to be fulfilled to become a member of the network. Read more.



Inspection Results on Investigational Medicinal Products Published

From time to time, the MHRA publishes a summary of the results of inspections conducted by the authority, also from the area of investigational medicinal products. Here you will find the current data.


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