Approval of new drugs

The final legal instrument is a Decision. A decision focuses on an individual measure and is directly binding in its entirety on the specific individuals or entities to whom it is addressed. The Commission uses Decisions to issue marketing authorisations for approval of new drugs granted under a centralised procedure (see Chapter 6). Figure 1.2 summarises the relationship between various legal instruments used in Europe. 

Approval of New Drugs when Human Efficacy Studies are not Ethical or Feasible... 

Hess, G. (1999). FDA accelerates its approval of new drugs. Chem. Market Newsletter 255 ... 

Establishes a fast-track system for the study and approval of new drugs that address unmet medical needs related to serious or life-threatening conditions. 

Provides for the use of scientific advisory committees to provide expert advice and recommendations to FDA regarding clinical investigation and approval of new drugs. 

Governments are also key players in the development of new drugs. They regulate and provide guidance for the development and approval of new drugs for marketing. In some countries they also play a role in pricing and reimbursement. After the launch of a new product they closely follow its safety, quality and various other aspects such as inappropriate use, promotion, etc. 

All drugs entering the Chinese market are approved by the state FDA (13). The nonclinical safety assessment process of pharmaceuticals in China is very similar to that of other countries. Most up-to-date data requirements for the approval of new drugs are available on the Web site of Center for Drug Evaluation (CDE) of the SFDA (http //www.sfda.gov.cn/). 

Kessler DA, Hass AE, Feiden KL, et al. Approval of new drugs in the United States. Comparison with the United Kingdom, Germany, and Japan. JAMA 1996 276 1826-1831. 

The FDA is responsible for the review and market approval of new drugs, biologies, and medical devices in the United States under the authority of the Federal Food Drug and Cosmetic Act (the Act) and Section 351 of the Public Health Service Act (the PHS Act). The FDA defines premarket review as the examination of data and information in an application as described in Sections 505, 510(k), 513(f), 515, or 520(g) or 520(1) of the Act or Section 351 of the PHS Act. This refers to the premarket review of data and information contained in any Investigational New Drug application (IND), Investigational Device... 

M., Mann, D., Firn, A. Michaels, Europe set for fast track approval of new drugs onwww.FT.com, July 18,2001. 

The editors and authors of the different chapters are scientist mainly active in the European pharmaceutical industry with a proven record of many worldwide approvals of new drugs, i.e. they have the practical experience to make a pharmaceutical product out of do a chemical compound. 

J Cook, P Prunella, S Stringer, M Yacura. Approvals and non-approvals of new drug applications during the 1970s. OPE Study 57, PB 81-14865. Rockville, MD U.S. Food and Drug Administration, 1980. 

Most regulatory bodies, concerned with the approval of new drugs for clinical use, do not accept the results of uncontrolled studies as stand-alone evidence of efficacy. There are, however, circumstances under which data from uncontrolled studies can provide acceptable evidence of efficacy (a) the treatment results in consistent and clinically significant improvement in a disease with a well-established natural course and remission rate, (b) the treatment consistently results in significant improvement in all or almost all patients. 

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