Product classes with their own requirements

Some classes of medicine take a route to authorisation, or carry documents, of their own because of what the product is. This branch covers those classes, and its parts divide by the class of medicine: a generic, hybrid or biosimilar that follows a medicine already authorised, an advanced therapy based on genes or cells, and a medicine for a rare disease with its orphan designation. It leaves the standard application, dossier and dialogue with the agency for a human medicine to the rest of marketing authorisation; whether a product is a medicine at all, and the dossiers for cosmetics, chemicals and pesticides, to other regulated products; a veterinary medicine's dossier to authorising a veterinary medicine; and a product that combines a medicine and a device to devices with requirements of their own.

• Generics and biosimilars — choosing the legal route for a medicine that follows one already authorised, what a generic is and the documents across its life cycle, what a biosimilar is and how one is developed, a biosimilar's clinical study reports and submission documents, the safety documents for both, interchangeability and the biosimilar market, and explaining these medicines to lay readers
• Advanced therapy medicinal products — what counts as an advanced therapy, the few early authorisations and the 2016 expert meeting, the 2017 action plan, the growth of the field, and the one manufacturing process every batch is held to
• Medicines for rare diseases and their orphan designation — why these medicines are orphans and the writer's role in developing them, the designation criteria and incentives in each region, the EU procedure and the application in the EU, the US and Japan, prevalence data, the orphan documents at the marketing authorisation application and the confirmatory data after approval, writing the clinical documents for a rare disease, how the FDA and the EMA differ and their cluster on rare diseases, and what an experienced rare-disease writer adds