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Pages 1-6

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From page 1...
... Innovations in turing in the next 5–10 years for products regulated by manufacturing technology to synthesize active pharmaCDER.1 The agency also asked that technical and regu- ceutical ingredients (APIs) or drug substances include latory challenges be identified and suggestions provided photochemical and electrochemical approaches, biocatalto overcome the regulatory challenges.2 It is important ysis, cell-free protein synthesis, and cell-based biosyntheto note that the committee was not asked to recommend sis that uses alternative hosts.
From page 2...
... The technologies can tailor the desired char- THE EFFECT OF PRODUCT REVIEW acteristics of a drug product -- for example, its geometry, AND APPROVAL AS THE BASIS OF porosity, and API composition -- and customize them for ACCEPTANCE AND IMPLEMENTATION OF a specific indication or an individual patient requirement. MANUFACTURING TECHNOLOGY Additive manufacturing also enables monitoring and acceptance or rejection of a product at the individual-dose An important factor in the pace of manufacturing inlevel and can be scaled down to a compact size and thus novation is the reality that formal regulatory review of potentially support highly distributed manufacturing.
From page 3...
... Even when a first such approval is achieved, it will take much time and effort -- THE NEED FOR GLOBAL CONVERGENCE through the review and approval of other products -- be- AND HARMONIZATION fore a particular manufacturing technology is broadly and successfully adopted. Differences in regulatory expectations and require ments of international health authorities pose consider THE NEED FOR ALIGNMENT able challenges.
From page 4...
... that is direct- Second, there appear to be capacity constraints that affect ed explicitly to the commercial phase of the product life consistency in evaluating innovative technologies. Views cycle and constitutes a major effort to address issues that expressed in the committee's workshops suggest that the have hindered the full realization of the vision of a more Emerging Technology Program lacks sufficient capacity flexible and agile pharmaceutical-manufacturing sector to sustain external engagement with industry, cultivate that has been advocated for the last 2 decades.
From page 5...
... It recomrisk to product quality. An innovation might introduce mends that CDER examine internal practices to increase new uncertainties regarding product quality that cannot technical fluency among its scientists through such acbe fully eliminated, especially for complex drug products, tions as evaluating priorities in hiring and retention pracand it is unclear how regulators will weigh risks and ben- tices and ensuring that staff-development plans support efits associated with innovations that greatly enable flex- continuous education on innovative technologies.
From page 6...
... Thus, neither manufacturers nor regulators are able key regulatory agencies through information exchange, to take a fully strategic, system-focused approach to the training, and mechanisms to support mutual recognition implementation of advanced manufacturing technology. programs for inspections.


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