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 biotechnology products in Indonesia

Dr Lucky S. Slamet, Indonesia

One of the advantages of biotechnology, including DNA technology, is that it allows the production of large quantities of therapeutic products that are difficult to prepare from natural sources using a conventional approach, or that are otherwise unavailable. The development implies a potentially limitless supply of drugs and vaccines.

Biotechnology products are probably the best purified and characterized biological medicines in clinical use. Their nature and production are highly sophisticated and must comply with international guidelines on standardization and control. However, the quality, efficacy and safety of such biological medicines in humans still needs to ensured through regulation, such as premarketing approval and licensing, and postmarketing inspection. Considerable emphasis must also be given to “in-process” controls on the starting material and the manufacturing process, as much as to the analysis of the final product. Data are needed on quality and purity of cell culture and on the effectiveness of purification and test methods. Furthermore, the ability of the purification process to remove unwanted materials, such as DNA and potential viral contamination, must also be validated.

The existing international guidelines on the production and control of biotechnology products have helped the Indonesian authority to regulate these products before and after marketing. Regulation covers the critical functions needed to ensure the quality of biologicals, i.e., a published set of requirements for licensing, surveillance, system of lot release, laboratory testing, regular inspection for GMP, and evaluation of clinical performance.

For licensing, the basic criteria for evaluation cover the main aspects of safety, efficacy, relevance to actual needs, quality, and compliance with GMP. Confirmation of safety and efficacy is based on review of preclinical and clinical data. For quality, evaluation covers control of the manufacturing process, from starting materials to final product. However, with the increased production capacity for biotechnology products, not only in developed but also in developing countries, regulatory measures as well as the authority’s scientific capacity for premarketing evaluation needs to be strengthened, including the capacity to oversee clinical trials, ensure compliance with GMP, and carry out postmarket quality assurance and safety monitoring of such products.

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