Regulatory authorities Harmonization

The approach taken to these issues can significantly influence post-application exposure assessments and lead to divergent outcomes by regulatory authorities. Harmonized approaches to analysis of dissipation kinetics are therefore needed. 

Currently, there are a number of harmonization activities in progress. Most of these involve harmonization of data and dossier formats and tend to be paper based. Harmonization efforts on work sharing are also currently under way among international regulatory authorities. Work sharing is facilitated by common formats for data... 

The Electronic Common Technical Document (eCTD) is the vision for future electronic submissions to the FDA. This specification was developed by the International Conference on Harmonization (ICH) as an open-standards solution for electronic submissions to worldwide regulatory authorities. The FDA has adopted the eCTD as the future replacement for its other e-submission guidance, although for now the older guidance is still in effect. Note that the eCTD still depends largely on submitting text documents as PDF files and submitting data sets as SAS XPORT transport format files. 

In recent years, regulatory authorities and industry associations have undertaken several important initiatives to promote international harmonization of regulatory requirements. These efforts are designed to enhance harmonization and are committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. These efforts are undertaken under the auspices of the International Conference on Harmonization (ICH), which is organized to provide an opportunity for tripartite... 

The CTDs were implemented in July 2003. They are format-based documents for submission to the regulatory authorities the country-specific process of review, for example, via the IND and NDA of the United States or the Centralized Procedure of the EMEA, is not affected. The harmonized CTDs help to reduce cost and accelerate approval time. Figure 7.1 shows the CTD structure five modules with Module 1 for regional administrative information specihc to each country. Module 2 on summary of quality, nonclinical and clinical. Module 3 on quality. Module 4 on nonclinical study reports, and Module 5 on clinical study reports. 

ICH home page. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), a unique project that brings together the regulatory authorities of Europe, Japan and the USA, and experts from the pharmaceutical industry. 

In 1996, the VICH program was officially launched among the European Union, Japan, and the United States (52). Among the objectives of the VICH is to provide a forum for a constructive dialogue between regulatory authorities and the veterinary medicinal products industry on the real and perceived differences in the technical requirements for product registration in die three jurisdictions, with tlie expectation that such a process may serve as a catalyst for a wider international harmonization. VICH should identify areas in which modifications... 

The various national and international regulatory authorities have used different hazard classification systems in the past. In light of the importance of hazard classification, the Organisation for Economic Cooperation and Development (OECD) recently harmonized criteria for hazard classification for global use. For example, the five harmonized categories for acute oral toxicity (in mg/kg body weight) are 0-5, 5-50, 50-300, 300-2000, and 2000-5000. 

This chapter will focus on some, but not all, of the areas in which the U.S. Food and Drug Administration (FDA) and the European Union (EU) regulatory authorities have attempted to coordinate their efforts to provide uniform rules and standards for the pharmaceutical industry. Specifically, we will review the efforts to harmonize approaches relating to inspections (including public disclosure of confidential information) and product approval or authorization (including clinical trials). While space limitations do not provide sufficient opportunity to describe each regulatory authority s system or the harmonization attempts in detail, it is our hope to provide some background of where the efforts are now, where the efforts are intended to go, and what we believe will be the results of these efforts. In addition, the author is much more familiar with the U.S. system than the EU system because of his experience and daily exposure with FDA, this chapter will focus more on the U.S. structure. 

The Branch also works with international organizations, including regulatory authorities in other countries, to harmonize regulatory standards and processes for therapeutic products. 

Given that global trade and international harmonization are key to the development of a sustainable life sciences industry, closer international cooperation is key to tackling technical barriers to trade in medicines. In addition to the ICH process, increasingly regulatory authorities have entered into agreements to enable them to exchange confidential information about approval and safety of medicines. 

Many important initiatives have been undertaken between regulatory authorities and industry associations, particularly on a bilateral basis, to promote harmonization of regulatory requirements between the three regions Japan, USA and the European Community. ICH owes much to these initiatives of experts during international symposia. 

ICH can look back to 15 years of achievements. As the most successful international harmonization initiative in the world, its achievements include an understanding of innovation a common regulatory platform based on more than 40 guidelines improvement of scientific guidelines facilitating communication between the regulators, and between industry and the regulatory authorities effective use of research and development... 

---