Biomedical Engineering Reference
In-Depth Information
Council Regulation (EEC) 2309/93
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creates the centralized community proce-
dure, in which a single marketing authorization application (MAA) is submitted
directly to the EMEA. There is a single evaluation and a single market authoriza-
tion allowing direct access to the European Union. This procedure is compulsory
for medicinal products developed by means of one of the following biotechnologi-
cal processes outlined in the Annex to Regulation 2309/93,
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Part A.
'Part A products are medicinal products developed by means of one of the
following biotechnological processes:
• recombinant DNA technology
• controlled expression of genes coding for biologically active proteins
in prokaryotes and eukaryotes including transformed mammalian cells
• hybridoma and monoclonal antibody methods.'
The centralized procedure may also be used for innovative new products as
described in the Annex to Regulation 2309/93, Part B.
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There are two scientific committees in the EMEA responsible for overseeing
applications and preparing the Agency's opinions. The Committee for Proprietary
Medicinal Products (CPMP) is responsible for drugs for human use and the
Committee for Veterinary Medicinal Products (CVMP) is responsible for veteri-
nary products.
Four to six months prior to submission in the centralized procedure, applicants
are asked to notify the EMEA of their intention to submit an application and
provide the intended month of submission. The letter of intent to submit should
include a justification of the product's eligibility for evaluation under the central-
ized procedure. Additional information about the content of the letter of intention
to submit and the centralized procedure can be obtained from the EMEA website
at www.emea.eu.int.
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7.4
Combination products
The Food and Drug Administration (FDA) Safe Medical Devices Act (SMDA) of
1990
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explicitly recognized the existence of products that 'constitute a combina-
tion of a drug, device, or biological product' and provided a mechanism for
determining which agency within the FDA would be assigned the administrative
responsibility of regulating a particular combination product. Currently, medical
products could be reviewed by the Center for Devices and Radiological Health
(CDRH), the Center for Drug Evaluation and Research (CDER) or the Center for
Biological Evaluation and Research (CBER). The Food and Drug Administration
Modernization Act of 1997 (FDAMA)
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further refined the assignment process by
providing a mechanism for requesting that FDA classify a product as a drug,
biological product, device, or a combination product, in addition to determining
which agency within the FDA would be assigned to regulate the product.
