EU Product Registration Ep.12

If the timeline is the same for novel food, what category of products do we need to file for novel food registration and is there a difference between pharma and food products? 

Yes, it’s quite different, primarily because we are discussing food, which falls under the category of nutritional proposals rather than therapeutic proposals. Therefore, the focus and purpose of the product are completely different. In the case of food, the company is not required to prove its effectiveness since there is no therapeutic indication. The main aspect that needs to be demonstrated is that the food is safe for human consumption. 

Regarding novel food, the process follows a distinct path. There is a central European authority for food called the European Food Safety Authority (EFSA), which is located in Italy. EFSA is the scientific agency responsible for evaluating novel food dossiers. Once EFSA has assessed the dossier and determined that the novel food is safe for human consumption, the opinion is then submitted to the European Commission. The European Commission, as the political entity of Europe, has the authority to authorize the food for the European market. 

What is the proper way to have an EU GMP certificate for finding a CMO in Europe? 

What is important is to liaise with knowledgeable people, specifically with knowledgeable and qualified personnel who can guide a company in obtaining the EU GMP certificate. First and foremost, you need an EU QP audit. You shouldn’t proceed with anything else until you have that in place. It won’t be considered serious unless you have the audit completed. Once the audit is carried out, you need to determine whether you’re going to apply with a dossier or without one. Additionally, if possible, you should include any other activities that can help prioritize the application, such as submitting it together with a batch release site.