Have a look at this timeline that Asphalion experts have prepared for you to take into consideration about the regulatory requirements for Data Disclosure. You can also discover Asphalion’s expertise on EMA Policy 0070 Policy, EMA Policy 0043, CTIS, etc., linked to EMA requirements.
Have a look at the document here: Data Disclosure Regulatory Requirements
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This guidance recommends steps manufacturers and applicants of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in drug products. The guidance also describes conditions that may introduce nitrosamine impurities. The unexpected finding of nitrosamine impurities, which are probable or possible human carcinogens, in certain drug products has made clear the need for a risk assessment strategy for the potential presence of nitrosamines in any drug product.
The US Food and Drug Administration (FDA) and The European Medicines Agency (EMA) have published new guidelines or draft guidelines. FDA Guideline updates: FDA Guidance
On July 22nd, the European Medicines Agency (EMA) published a draft guideline titled “Guideline on the Development and Manufacture of Oligonucleotides” (EMA/CHMP/CVMP/QWP/262313/2024-17 July 2024). This
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