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EU Moving to Tighten GMP Requirements on Outsourcing and Supply Chain Control

Changes to the EU regulations that govern technical agreements, outsourced activities, active pharmaceutical ingredient (API) supply chains, and the storage and transit of medicines are in progress and expected to be released soon for public consultation....

EU and Cambodia Take Steps to Fight Counterfeit Drugs

The EU and Cambodia have recently taken additional steps in the fight against counterfeit drugs: the Council of Europe (EC) updated the EU draft guidance on “falsified medicines,” and Cambodia initiated a crackdown on illegal pharmacies operating in their country.....

European Trade Associations Step Up to the Plate on Drug Counterfeiting

Two trade associations in Europe, through separate but related efforts, are advancing the dialogue on preventing counterfeit medicines from entering the legitimate drug supply chain: one by publishing a set of guiding principles to call attention to the issue; the other by successfully executing a pilot program on security of drug products in the supply chain....

EMA Updates Facility Inspection Procedures to Align with EU GMP Guide Revisions

The European Medicines Agency (EMA) has updated its GMP facility inspection procedures to align with recent revisions to its EU GMP Guide reflective of ICH Q8-10 principles....

Draft Revision of EU Annex 2 For Biologicals Out For Comment

The European Commission has published a revised draft of Volume 4, Annex 2, “Manufacture of Biological Medicinal Substances and Products for Human Use.” This revision is taking place due in part to the need to include an increased range and complexity of biological products, and new products such as advanced therapy medicinal products....

MHRA is Requiring Interim Update Reports for Risk-Based Inspections

MHRA is requesting that all manufacturing sites inspected after April 1, 2009 under its risk-based inspection (RBI) approach submit interim updates to communicate significant changes between inspections....
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