Regulatory Approval Procedures in USA

J. Praveen Kumar¹, Rajendran Sai Divya², Dr. M. Kishore Babu³, Dr. P.V. Murali Krishna^4
1Associate Professor, Krishna Teja Pharmacy College, Tirupati, Andhra Pradesh.
²Krishna Teja Pharmacy College, Tirupati, Andhra Pradesh.
³Principal, Krishna Teja Pharmacy College, Tirupati, Andhra Pradesh.
⁴Associate professor, MNR College of Pharmacy, Sangareddy, Hyderabad, Telangana.

A B S T R A C T
The Food and Drug Administration (FDA) is responsible for protecting and promoting public health. Like general drug approval process, FDA’s new drug approval process is also accomplished in two phases: clinical trials (CT) and new drug application (NDA) approval. FDA approval process begins only after submission of investigational new drug (IND) application. A new drug application (NDA) can be filed only when the drug successfully passes all three phases of clinical trials and includes all animal and human data, data analyses, pharmacokinetics of drug and its manufacturing and proposed labelling. An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Generic Drugs once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. The major pharmaceutical markets in the world are different requirements for the registration of a pharmaceutical product. To harmonize the requirements as per the regulatory agencies, a concept of common technical and its electric version was implemented by ICH. As the CTD consist of 5 modules; some modules are common to all regions. The quality, safety and efficacy data has its own importance in the registration dossier. The commercial significance of markets is increasing globally. It is vital for pharmaceutical industry to cope with the regulatory requirements for betterment of public and to ensure their place in the market. This project approaches the registration requirements in the form a dossier for market authorization. It also has drawn a comparative statement on various approaches for harmonization of registration requirement for pharmaceuticals.
Keywords: New Drug Application, Common Technical Document, ANDA, Food and drug administration