GMP NEWS 2009

Result of the Public Consultation on the Revision of the PIP Guideline Published

The results of the public consultation on the revision of the so-called PIP Guideline ("Commission Guideline on the format and content of applications for agreement or modification of paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on the criteria for assessing significant studies", 2008/C 243/09) have been published by the European Commission. Read more here.

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Pharmaceutical Development: EMEA QWP plans for 2009

The European Medicines Agency (EMEA) CHMP/CVMP Quality Working Party (QWP) has published its joint Work Programme for 2009. This document gives an overview about current and future activities of the joint QWP Work Programme. Read more.

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EU Commission and EFPIA Activities against Counterfeit Medicine

The Commission, Member States' customs experts and pharmaceutical specialists met and identified key risk indicators and high risk pharmaceuticals to be the subject of reinforced controls. Read more here.

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New ICH Q4B Annexes

Under the roof of ICH, the Pharmacopoeial Discussion Group and the ICH Q4B Working Group have been dealing for years with the harmonisation of the requirements laid down in the pharmacopoeias of the three ICH regions. Get more detailed information here.

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European Variations Regulation Published

In the Official Journal of the European Union, the "Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products" was published. Read more.

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Annex to ICH Q8 Pharmaceutical Development reached Step 4

The Annex to ICH Q8 Pharmaceutical Development reached Step 4. This document builds on key concepts outlined in the core guideline, and shows how tools such as Quality by Design could be put into practice. Read more.

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FDA Opens Offices in China and Tightens Inspections Also in Europe

As many as 3 offices have been opened in China by the FDA in order to increase the number of GMP inspections. But the Agency is also planning or already implementing offices in other regions - among them Europe - as well as stricter measures for their foreign inspections. Read more here.

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