News about GMP/cGMP

05.05.2017

EMA Should Clarify Role in Collaboration on Non-EU Drugs, Officials Say

The European Medicines Agency plans to clarify its role regarding drugs manufactured in the EU solely for the export market.

EMA officials met with delegates from European and African nations to discuss the issue in a recent workshop in Malta.

The EMA’s Committee for Medicinal Products for Human Use said the agency should improve its communications relating to GMPs and inspection in dealing with the World Health Organization and regulatory bodies in target countries.

One way to reconcile different GMPs and gaps in the quality part of the assessment would be to append the WHOs Quality Information Summaries to CHMP medicine reports, the workshop concluded.


Sources:

FDAnews: FDAnews Drug Daily Bulletin Pharmaceuticals / Quality

EMA: Events



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