GMP: Regulatory Monitoring of API Manufacturers - FDA, TGA, EMA and EDQM express Common Objectives for Inspections Collaboration

On 6 March 2012, the EMA published a paper entitled \"Programme to rationalise international GMP inspections of active pharmaceutical ingredient/active substances manufacturers - Terms of reference and procedures for participating authorities\". This publication presents the conditions which must be met by the monitoring authorities to actively take part in the collaboration programme but also precisely defines the requirements for collaboration and information sharing.

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