#ICYMI – Featured Articles from the Acorn Regulatory Archive
Our #ICYMI series has looked at some of the best articles that have been written by members of the Acorn Regulatory team. They also present a good opportunity to bring to your attention articles that you might not have seen before and that might be useful to you. This edition of the #ICYMI series looks at well established use, using a US dossier for an European application, how constant changes to legislation and directives can impose additional pressures on regulatory professionals and how new methods of conducting audits can help a company’s bottom line.
In this blog, John McIntyre looks at one of the most crucial choices Marketing Authorisation Holders must make when submitting a marketing authorisation application (MAA) – the choice of legal basis.
In the European Union (EU), the legal basis of a MAA is laid down in Directive 2001/83/EC as amended. The choice of legal basis in turn will determine the dossier content, paediatric requirements and data exclusivity. Legal basis is therefore of critical importance from a regulatory perspective. Read more here.
Over the years, we have worked with a significant number of US innovator companies and supported them getting their ‘US developed medicinal product’ registered as a medicinal product in Europe. In this article, we look at some of the issues we have encountered in taking a US developed dossier for a new marketing authorisation application in Europe on behalf of a client. Read more here.
3. How Ever-Changing Regulatory Demands Will Impact Small and Emerging Pharmaceutical and Medical Device Companies
As regulations and guidelines become broader, more electronic and increasingly data driven, manufacturers must adapt with ever changing demands. Regulators are shifting more responsibility onto manufacturers to instil quality throughout their operations and throughout their product lifecycles. In the past, small and emerging life sciences companies might have functioned sufficiently with manual processes and disconnected systems, but may now be unable to satisfy the requirements of regulators whose fundamental shift is a growing focus on electronic processes, data driven decisions and increased transparency to information.
Some examples where manufacturers will need to address their systems and processes based on recent changes in the industry, are discussed in this article. Read more here.
In accordance with GVP Module I, the MAH is responsible for performing risk-based audits of the quality system at regular intervals including audit of the PV system. The methods and conduct of these audits are outlined in GVP Module IV. Read more here.
We will feature many more articles from our archive as the #ICYMI In Case You Missed It series progresses. Feel free to share any articles of interest by using any of the links below.