Drug approval systems

The European Medicines Agency and the new EU drug approval systems... 

In 1993, a significant advance in simplifying the procedures relating to drug marketing authorization applications in the EU was made. At that time, the legal basis of a new drug approval system... 

The Pharmaceuticals and Cosmetics Division (Koseisho) of the Pharmaceutical Affairs Bureau of the Ministry of Health and Welfare (MHW) is the regulatory body in Japan. Also in Japan there have been clear changes in the drug approval system, mainly inspired by ICH. One of the most important recent changes is that, under certain conditions, it is now possible to use also foreign data for the approval of new dmgs in Japan. 

The EU drug approval process is working toward a harmonized FDA-type system. The transformation is not yet complete, however, and currently the EU has two drug approval systems in place. 

The EU drug approval system is moving toward harmonization. A system that permits individual states to reject the centralized body s recommendation is a significant obstacle to this goal, however. One author has written... 

The FDA would look for foreign drug approval systems with sufficient high standards to warrant U.S. approval on the basis of an approval in these other countries. 

Hilts, P. J., Top FDA Staff Members Oppose Looser Drug Approval System, The New York Times, December 20, 1991, p. A29. 

Because these types of polymeric matrix systems are the simplest to design and the easiest to obtain approval by the Food and Drug Administration, they have been the most extensively studied in the past two decades. Numerous polymers have been evaluated for these types of drug delivery systems and although it would be impractical to present each of these polymers and its specific application to drug delivery, this chapter will review in general the types of polymers used as matrices for drug delivery (1-4). 

With one exception, all the chapters from the third edition of Modern Pharmaceutics that appear in the fourth edition have been revised and updated. Many chapters were extensively updated, and some, such as the first and last chapters, were extensively rewritten. Due to the illness of Dr. Robinson, the chapter on sustained and controlled release drug delivery systems was updated with the assistance of Gil Banker, with Dr. Robinson s approval. 

The second major change enacted under the 1962 amendment was the change in the approval process from premarket notification to a premarket approval system. Under the terms of the 1938 law, an NDA would take elfect automatically if the FDA did not respond. For example, the only reason thalidomide was not approved was because Dr. Kelsey returned the application to the sponsor with a request for more information. In contrast, the 1962 law required affirmative FDA action before a drug could be put on the market. Under the terms of the 1962 amendments, the FDA was also empowered to withdraw NDA approval and remove the drug from the market for a variety of reasons, including new evidence that the product was unsafe or that the sponsor had misrepresented or under-reported data. 

All new drug applications are expected to be in the CTD format according to ICH guidelines (see Section 7.11). Priority reviews are applicable for orphan drugs and those drugs for the treatment of serious illnesses. A restricted approval system has been implemented for emergency drugs to prevent spread of diseases. In this case, the standard review procedure is not applicable. 

In 1997, the Ministry of Health and Welfare extensively reformed the drug evaluation system and established the Pharmaceuticals and Medical Devices Evaluation Center affiliated with the National Institute of Health Sciences. Under the new system, the Center, through its specialized teams, conducts the evaluation of drugs for which different pharmaceutical companies have sought approval. 

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