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MRA comes into force between the FDA and the EU

The first of November 2017 has become a notable and unprecedented date in the history of medicines regulation. This is the first day of coming into force of a Mutual Recognition Agreement (MRA) of Good Manufacturing Practice (GMP) inspections of manufacturers of medicines for human use between the FDA and the EU. This initial stage … Continued

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Impact of Brexit on the Regulation of Medicines and the Pharma Industry?

We have a unified Medicines regulatory system in the European Union and Economic Areas. The UK regulator is a significant player in respect of European regulatory procedures and is recognised as a source of considerable scientific and regulatory expertise. Now we have Brexit and a schism which will eventually arise as the UK leaves the … Continued

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When is an IMP not an IMP? When it’s an AMP.

The definition of Investigational Medicinal Product (IMP) and the use of Auxiliary Medicinal Product (AMP) are the subject of a recent consultative document from the European Commission’s expert group on clinical trials for the implementation of regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. The consultative document was published on … Continued

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Reflection on GMP/GDP Consultative Committee Minutes: 18th April 2016

The GMP/GDP consultative committee met recently on the 18 April 2016 at the MHRA offices in Buckingham Palace Road, London. The attending bodies consisted of quality associations, Industry associations and professional organisations. Among the many interesting topics discussed were the topical subjects of data integrity and harmonisation.

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GXP data integrity culture and unity

If you turn to that font of all known knowledge, the internet and search the term “data integrity” you will find a common definition of “maintaining and assuring the accuracy and consistency of data over its entire life-cycle”. All in all this is not a bad definition.

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