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Comparison Of Drug Approval Process In United
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Comparison of Drug Approval Process in United States & …
www.jpsr.pharmainfo.inDrug approval process in both the regulatory agencies has been summarized for easy understanding.[1] The basic regulation can be understood from Fig 1. Drug Approval in United States:- The United States has perhaps the world’s most stringent standards for approving new drugs. Drug approval standards in the United States are considered by many ...
Guideline on stability testing for applications for ...
www.ema.europa.euafter approval. This guideline is an extension of the CHMP and CVMP Guidelines on s tability testing of existing active substances and related finished products and the respective ICH/VICH Guidelines for new active substances and drug products. It is intended to be applied in the European Union.