New Drug Development and Approval



New Drug Development and Approval

Introduction

Drugs have been a serious problem in the United States. Since everybody has their own personal reasons why they do such a thing as use and abuse drugs, it makes even more difficult to prevent such a crime. Preventing the drug use has been a major issue in the area of politics, schools, or within the families (Hoffman, 1990).

New Drug Development and Approval

Step By Step Process

Drug laws, norms and standards

Implementing drug regulation

Monitoring and evaluation

Control of Drug Promotion and Advertising

Drug laws, norms and standards

Legal structures form the foundation of drug regulation. Some drug laws traditionally omit or exempt certain areas of pharmaceutical activity from their scope of control, thus resulting in a regulatory gap. For instance, some countries do not require registration of herbal and/or homeopathic drugs while, in others, legal mandates are not imposed on the importation of drugs. To protect the public from harmful and dubious drugs and practices, drug laws should be comprehensive enough to cover all areas of pharmaceutical activity in the country (Hoffman, 1990).

While drug laws provide the basis for drug regulation, regulatory tools such as standards and guidelines equip drug regulatory authorities with the practical means of implementing those laws. Not all drug regulatory authorities provide documented standard procedures for registration, and even fewer provide documented guidelines and checklists for inspection. These tools should then be used to guide regulatory practice, as well as being made publicly available to all the parties involved in order to bring transparency to the drug regulatory process (Trissel, 1998).

Implementing drug regulation

Several areas in drug regulation receive relatively little attention in the implementation process. The informal sector, post-marketing surveillance and control of drug information was the most important of these (www.geocities.com).

Counterfeit products, products of dubious quality and faulty information - ...