Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Close this folderRegulatory challenges of new technologies
View the documentThe EU regulatory system in the international environment
View the documentFDA/CBER regulation of emerging therapies
View the documentList of participants
View the documentBack cover
 

Regulatory challenges of new technologies

Moderator: Dr John Lim, Singapore

In recent years there has been much research and development in the use of new technologies - such as biotechnology and combination products as therapeutic agents. There are approximately 200 biotechnology products on the market and more than 350 in the late development stage. These products include recombinant peptides and proteins, modified proteins, monoclonal antibodies and related products, gene transfer products, cell-based therapies and engineered tissue products.

Research and development in biotechnology will continue to grow. Regulatory agencies worldwide have a vital role to play in safeguarding public health and in the continued development of such products. Biotechnology products differ from traditional synthetic chemical medicines in several important aspects, including immunogenicity, the inherent greater variability of the manufacturing process, the more limited applicability of animal models, and a greater potential for microbial contamination and the transmission of disease.

The history of clinical use of therapeutic biologicals is extremely short. Sharing and exchange of information between regulatory agencies worldwide will be extremely beneficial in the process of developing new regulations and guidelines. The challenge to both regulators and industry will be to remain vigilant in designing new approaches to risk management and risk communication to ensure the safe use of these products without unduly hampering the development of these exciting technologies.

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