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Abstract

Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing of new drug by the applicant by Regulatory authority in any country. Once preclinical and clinical trial data have been collected, a New Drug Application must be submitted to the regulatory authority for approval. Although the requirements for this submission have similarities around the world, until now, the applications have been different. Substantial documentation and data are required in these types of submissions, resulting in large, complex applications. Till date, applicants have used many different approaches in organizing the information and the differences in organization of data in each application has made reviewing more difficult and can also lead to omission of critical data or analyses.  Thus, a common format of submission will help in overcoming these hurdles. With the help of regulatory guidelines laid down by the respective countries Australia and New Zealand, the marketing of drugs are been done under proper guidelines. The implementation of safety recall methods have also proven helpful in retaining a drug or pharmaceutical from the current market and avoiding the sale of such adverse drug on the health care of common public.


The Amendments, guidelines, drug approval process and safety recall procedures play one the important role in the country’s fate in pharmaceutical industry.

Keywords

TGA Medsafe Drug Approval Process Safety Recall procedures

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