Abstract

AN OVERVIEW OF NEW DRUG APPROVAL PROCESS AS PER USFDA FOR TRANSDERMAL PATCH WITH NEUPRO AS AN EXAMPLE

*Abdul Mannan, Aymen Fatima, Mohd. Farhan, Shaik Habeeb and Yasmeen Fatima

ABSTRACT

Transdermal drug delivery systems (TDDS) are dosage forms involves drug transport to viable epidermal and or dermal tissues of the skin for local therapeutic effect while a very major fraction of drug is transported into the systemic blood circulation. Regulatory affairs are a comparatively new profession which has developed from the desire of Government to protect the public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetic and complementary medicines. The pharmaceutical industry is an outstanding example of successful collaboration between scientists of various disciplines to develop new and effective drugs. It can take over ten years from the time a drug is discovered the mandatory clinical phases and obtain regulatory approval for the new medicine. Efficient information management can save valuable years and money associated with drug discovery & development process, and collaborative approach among professionals of various fields can accelerate the process of expediting and approval of new drug entities. A regulatory process, by which a pharmaceutical company (or) organization (or) sponsor (or) innovator gets authorization to launch drug in the market, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs.

Keywords: TDDS, New drug approval process, USFDA.