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EMA good manufacturing collaboration expanded


The ongoing collaboration on good manufacturing practice (GMP) inspections of active substance manufacturers between the European Medicines Agency and its international partners is to be expanded to include additional partners, according to new terms of reference, published today.

The World Health Organisation (WHO) has already become a new partner in this collaboration, through its Prequalification of Medicines Programme. WHO’s membership will contribute to its objective of there being safe and effective medicines for all.

The international collaboration initiative allows participants to share information on inspections, including planning, policy and reports, for manufacturers of active pharmaceutical ingredients that are located outside the participating countries. It also allows joint inspections to take place.

Prior to the recent expansion, the programme involved the European Medicines Agency, EU Member States, the European Directorate of the Quality of Medicines and Healthcare (EDQM), the United States Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA). The EU Member States had signed a confidentiality agreement with the FDA prior to taking part in the programme.

Based on the positive experience from a pilot running from December 2008 until December 2010, the participants agreed to continue with the collaboration, taking the lessons learned during the pilot into account.

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