by Michael Pfleiderer
Manufacturers of medicinal products operating within and outside the European Union (EU) or the European Economic Area (EEA) who aim at placing their products on the EU/EEA market often find it difficult to correctly interpret data requirements for a valid CTD. Uncertainties on the amount and quality of scientific data to be generated and on the way how to optimally present these data within the individual sections of the CTD very often create a major hurdle that cannot be overcome easily. Most notably, uncertainties and discrepant opinions on these issues can significantly complicate partnering processes between two or more enterprises that are dependent on each other for successful drug development and licensure.
Specifically, for biological medicinal product a common understanding between partners producing individual components of a medicinal product, i.e. Drug Substance (DS), Drug Product (DP), excipients, adjuvants or any other biological or non-biological substance on the completeness, adequacy and robustness of data is needed in order to successfully place a product on the EU/EEA market.
As such, a continuous compliance check with CTD requirements is a useful instrument and should be installed from the earliest time point onwards in order to achieve overall agreement between interested partners on the validity, correct interpretation and most effective presentation of data building up a CTD. This kind of strategy helps to avoid misunderstandings by regulatory agencies, issuance of comprehensive list of questions and, ultimately, massive extension of procedural time lines.
Moreover, within their respective legal frameworks regulatory agencies offer their support for certain (urgently needed) medicinal products in abbreviating development pathways and review time lines. Products eligible for such pathways require very specific strategies and unprecedented precision for meeting the agencies’ expectations regarding data generation, compilation and presentation.
Biopharma Excellence has developed tool boxes for effective compliance checks with the agencies’ expectations on data completeness and acceptability. These tools boxes are tailor made for individual products and licensing strategies.
If you are interested, please contact us and we will elaborate functional solutions for you and your partners.