News
GMP: GCP: EMA Draft Guideline relating to the Trial Master File
11.05.2017
In April 2017 the European Medicines Agency (EMA) has released a draft guideline on good clinical practice compliance in relation to trial master file (paper and/or electronic) for content,
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RAPS: EMA Drafts Guidelines on Controlling False Positives in Clinical Trials (6 April 2017)
11.05.2017
EMA Drafts Guidelines on Controlling Against False Positives in Clinical Trials.
The European Medicines Agency (EMA) has released draft guidelines about multiplicity in clinical trials. The ...
The European Medicines Agency (EMA) has released draft guidelines about multiplicity in clinical trials. The ...
EMA: New guide on biosimilar medicines for healthcare professionals
11.05.2017
The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines. Biosimilars are biological medicines that
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RAPS: UK on Brexit Implications: ‘Significant Benefits’ to Remain Part of EMA
23.03.2017
The UK government’s EU External Affairs Subcommittee on Tuesday published a report on the implications of Brexit on trade, noting that there may be “significant benefits” in
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MHRA: MHRA's Interpretation of Cross Contamination & PDEs
23.03.2017
The British inspectorate MHRA has recently published an interpretation that goes into detail on the use of health based exposure limits and explains the cases where EMA's new concept can be
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EMA: Regulatory cooperation to improve global health
23.03.2017
EMA experts meet with African regulators to discuss opportunities for collaboration.
How to improve the availability of high quality, safe and effective medicines to patients in countries
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EMA: Release of documents on two medicines temporarily halted
23.03.2017
Release of documents on two medicines temporarily halted.
EMA’s appeals against interim measures are dismissed by Court of Justice.
The Vice-President of the Court of Justice ...
EMA’s appeals against interim measures are dismissed by Court of Justice.
The Vice-President of the Court of Justice ...
MHRA: PIC/S statement to European Commission's ATMP GMP Guideline
23.03.2017
During the last months, we reported several times about the current activities of the EMA and European Commission relating to the new GMP Guideline document for Advanced Therapy Medicinal Products
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EMA: Promoting high-quality clinical research in children through strengthened international collaboration
10.02.2017
The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) will hold its ninth annual workshop on 16 May 2017 in London, UK. The aim of the workshop, that will take
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on the initiation of the review on conducting research by the company Micro Therapeutic Research Labs in India
05.01.2017
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on the initiation of the review on
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