Due to a revision of Chapters 1 and 2 of the EU GMP Guide in 2010 there should be an alignment with the concepts described in ICH Q10.

From 8 December 2009 onwards, the 'emea' part of the European Medicines Agency's website and e-mail addresses is replaced with 'ema'.

The Maas & Peither team would like to thank you for your continuous patronage. At this point we would like to especially thank the numerous partners and authors which are supporting us to keep our products up to the highest standards - so that our clients have the latest information at hand. We could not do this without you!

Season's Greetings and a prosperous New Year

Your Maas & Peither Team

FDA published recently the new ICH Q4B Annexes as Guidance for Industry.

FDA Expands Presence Outside U.S. with Opening of Mexico City Post the third in Latin America and the tenth internationally.

FDA published December 9 the new Guidance for positron emission tomography (PET) drugs.

Contract manufacturing is the hot topic of the December newsletter from Maas & Peither for GMP experts in the pharmaceutical industry.

A warning letter for a French API manufacturer was issued for cGMP deficiencies. There has been four major observations which forced the warning letter.