How to Interpret the Latest FDA Guidance on Manufacturing Establishment Information and its Relationship to IDMP Standards
The draft guidance on manufacturing establishment information coordinates all of the information about an establishment and its associated business operations into one structured format. The draft guidance states, “Electronic submissions of manufacturing establishment information (MEI) must include complete information on the locations of all manufacturing sites, including packaging and control sites, for both drug substance and drug product.”
When the conversation turns to Structured Product Labeling (SPL) our first thought is often about Prescribing Information. But as the US FDA and other regulatory bodies modernize review processes, electronic submissions are having an impact across more and more communications. Establishment Registration is one of the more critical SPL submissions and must be submitted annually to the FDA in a narrow window.
In the scheme of a large submission such as an original New Drug Application (NDA), the accompanying Structured Product Label (SPL) is often an afterthought. Small in scope should not be confused for simple – the SPL ranks as the most complex piece of your submission. The SPL standard is based on extensible markup language (XML), and the intricacies of this format are difficult to grasp. If you are unfamiliar with XML the probability...