Department of Pharmaceutics and Drug Regulatory Affairs, Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati– 517501, Andhra Pradesh, India.

Department of Pharmaceutics and Drug Regulatory Affairs, Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati– 517501, Andhra Pradesh, India.

Department of Pharmaceutics and Drug Regulatory Affairs, Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati– 517501, Andhra Pradesh, India.

Department of Pharmaceutics and Drug Regulatory Affairs, Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati– 517501, Andhra Pradesh, India.
WHO ,NDA ,ANDA ,Quality ,Safety ,Efficacy ,Filling strategy ,Communications ,

Drug regulation has developed over the past 50 years in response to crises in relation to pharmaceutical products. Current drug regulation was the comprehensive multi-country study undertaken by the World Health Organization (WHO). In order to register a NDA & ANDA molecules globally, a pharmaceutical company develops a dossier that describes the pharmaceutical quality, safety and efficacy of the product for a specified indication. New dossiers are generally assessed by following regulatory authorities; their decisions should be an adequate basis that depends upon the given data in a dossier for a molecule, usually the same for every country, although the proposed indication may vary. Based on the following parameters, Increase % growth in demand for the molecule year on year, Number of companies are already lunched, Price comparison with competitors, Marketing strategy we have selected a drug Bisoprolol Fumarate Tablet. This drug was filed in Kenya, Tanzania, Uganda, Malaysia, Bahrain, Kuwait, Oman, Qatar, Mexico, Peru, and Venezuela. After studying the regulatory requirements to register a pharmaceutical product for human use and after analysing the communications received from respective regulatory authorities filing strategy has been developed to improve the quality of the submission file which helps to reduce the number of deficiencies received from each regulatory authority. It also helps to reduce the product registration lead time which allows commercial team to launch the product at the earliest.

5 , 2 , 2015