Provisions For The Registration Of Stand-Alone Bioanalytical Laboratories

A proposal was made to make an amendment of the NDCT rules 2019 for including the provision of registration of stand-alone Bio-analytical laboratories by including the word analytical part in the definition as follows – BA and BE study center. This means a center that has been created for undertaking BA study or BE study of a drug for either the clinical part or the analytical part or both of them.

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