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
Close this folderRegulating biotechnology products
View the documentComparability of biotechnology products and cell substrates
View the documentAssessing biocomparability: a Canadian perspective
View the documentRegulatory aspects of nucleic acid vaccines
View the documentReport on WHO Monitoring Group on Gene Therapy
View the documentRegulating biotechnology products: Cuban experience
View the documentRegulation of products derived from recombinant DNA technology in China
View the documentRegulation of biotechnology products in the Republic of Korea
View the documentRegulation of biotechnology products in Indonesia
View the documentRecommendations
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
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Regulation of products derived from recombinant DNA technology in China

Professor Haijun Zhou, China

The major difference between recombinant DNA products and other pharmaceutical products is that biotechnology makes use of genetically modified living organism to produce proteins and peptides, whereas other pharmaceutical products are derived from naturally occurring substances, or by chemical synthesis. However, biotechnology products are no different from other biological products after the process of protein purification. For this reason, the requirements for process validation, environmental control, aseptic manufacturing and quality assurance are fundamentally similar. However, the complexity of the system is greater for biotechnology products because their production requires highly developed cell propagation processes and complicated purification methods.

The following principles underlie the regulation of r-DNA products in China:

• Specific concerns about particular products should be raised with the appropriate specialists on a case-by-case basis.

• A new licence application is required even if the active ingredient is identical in molecular structure to a naturally occurring or previously approved product.

• Differences can arise at different production stages. Because ability to characterize the identity and structure and to measure the activity of the clinically active components is limited, emphasis has to be put on the control of the manufacturing process.


The following need to be considered during the evaluation process:

• the different vector and host cells used in constructing the engineered cell;

• the specificity of different kinds of r-DNA products in different animals;

• the different usage and frequency of administration of specific products and their implications for the acceptable levels of impurities;

• the need for special attention to modified moieties;

• possible contamination with potentially hazardous impurities if the purification process is not capable of eliminating them;

• unintended variability in the culture, which may lead to differences in impurities and inconsistencies in the product itself.


In ensuring the quality of r-DNA products, controls must cover:

• Source materials: expression of vector and host cells, sequence of the cloned gene, and the measures used to promote and control the expression of the cloned gene.

• Manufacturing process: master cell bank, consistency of yield product from full-scale culture, criteria for rejection of the culture lots, etc.

• Final product: physicochemical characterization, biological tests for identity and potency, tests for contaminants.

• Preclinical toxicity evaluation.

• Clinical trials.

 

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