Genetically modified organism medicinal products

The Competent Authorities are allowed a maximum of 60 days to review the data, or 90 days in the case of trials involving medicinal products for gene therapy, somatic cell therapy (including xenogeneic cell therapy), and all medicinal products containing genetically modified organisms. Such trials require written authorisation from the Competent Authority as distinct from other types of product where the authorities may just notify the sponsor of the acceptability (no-objection) of the application. If issues are raised, the sponsor may amend the application once, with a consequent extension to the allowed review period. 

EMEA (2001) Discussion paper on environmental risk assessment on non-genetically modified organisms (non-GMO) containing medicinal products for human use. CPMP/ SWP/4447/00 draft corr. The European Agency for the Evaluation of Medical Products... 

EMEA (2001). Draft CPMP Discussion Paper on Environmental Risk Assessment of Non-Genetically Modified Organisms (Non-GMO) Containing Medicinal Products for Human Use. CPMP/SWP/4447/00. Pinal. European Agency for the Evaluation of Medicinal Products, London. 

FC EMEA FDA GCP GMO HAP HEPA HIV HTLV ICH European Commission European Medicines Agency Food and Drug Administration good clinical practices genetically modified organisms hamster antibody production high efficiency particulate air human immunodeficiency virus human T-Cell leukemia virus International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use... 

Nominated by decree, the Director General runs the Medicines Agency and makes decisions in the name of the State on matters relevant to the Agency. He intervenes in the application of the law of 28 December 1967 on birth control, the law of 13 July 1992 on the control of the use and dissemination of genetically modified organisms, and the law of 31 December 1992 relative to restricted products and activities with police and customs officials. His decisions are not susceptible to control from superiors. 

An environmental risk assessment may also be required, particularly for Genetically Modified Organism (GMO) medicinal products. The following should be considered genetic structure and stability, the possibility to disseminate and survive in the environment, the ability of the vaccine to transfer potential pathogenicity or virulent factors to other microorganisms, and its ability to stably convert to a toxicogenic phenotype.1920... 

Member states have 60 days to consider a valid request from an applicant to conduct a clinical study, in the case of trials involving medicinal products for gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms an extension of a maximum of 30 days may be allowed. If the request to conduct a study is refused by the competent national authority, the sponsor may on one occasion only modify or amend the protocol to take account of the objections raised. No further appeal mechanism is provided. 

Extension to the 60-day period is only permissible for trials of gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms. In such a case an extension of 30 days is permitted with a further extension of 90 days in the event of local MS consultation with a group or committee also allowed for, bringing the total to 180 days. There is /jo time limit for xenogenic cell therapy applications. 

Genetically modified organisms potentially could be very advantageous to people. Specifically, scientists claim that GMOs will be vital to the future of food production and therapeutic medicine. Given... 

There is significantly less controversy over the use of genetically modified organisms in industrial production and medicines. However, the use of genetic engineering techniques for human gene therapy and related applications has touched off a firestorm of ethical debate. 

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