Regulations Under Regular Review

The strategy gives unusual prominence to the regulatory response to the development and introduction of innovative production processes, especially for advanced therapy medicinal products (ATMPs) and continuous manufacturing by small production units. Differences in approaches Another major factor l...

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Bibliographic Details
Published in:Pharmaceutical technology Europe 2020-09, Vol.32 (9), p.6-8
Main Author: Milmo, Sean
Format: Article
Language:English
Subjects:
Batch processes
Data analysis
Digital technology
Good Manufacturing Practice
Innovations
Manufacturing
Marketing
Pandemics
Pharmaceutical industry
Production capacity
Supply chains
Technological change
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Summary:The strategy gives unusual prominence to the regulatory response to the development and introduction of innovative production processes, especially for advanced therapy medicinal products (ATMPs) and continuous manufacturing by small production units. Differences in approaches Another major factor likely to trigger changes in the document is the EU's Pharmaceutical Strategy for Europe (2), due to be published by the European Commission (EC), the EU executive, by the end of 2020. The EC is considering proposing expansions in European production capacity, especially for APIs, backed by the development of innovative production processes. [...]EMRN has concentrated on the laying of the regulatory groundwork for new manufacturing processes in the EU extensively in its strategy.
ISSN:1753-7967