A New Chemical Entity (NCE) can be defined as “a compound which, previously, hasn’t been described in scientific literature.
Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts.
Saigates can present your application for these products to the EMA through the European centralised procedures. This will include the List A which is a mandatory part of the procedure.
A biologically similar medicinal product (biosimilar) is a new biological product that has been developed to be similar to a “reference” product which is already existing in the market.
Advanced therapy medicinal products are new medical products based on genes (gene therapy), cells (cell therapy) and tissues (tissue engineering). These advanced therapies herald revolutionary treatments of a number of diseases or injuries, such as skin in burns victims, Alzheimer’s, cancer or muscular dystrophy. They have huge potential for patients and industry.
In the UK, the manufacture and supply of over-the-counter (OTC) medicines is tightly regulated to ensure products are safe, effective and of a high quality.
It is estimated that there are between 5000-8000 rare diseases. These diseases affect around 250 million people worldwide. An Orphan drug is one that has been developed to treat one of these rare conditions.
Specifically, from a regulatory perspective, an orphan drug is a medicinal product for human use that has been designated according to Articles 3 and 5 of the Orphan Drug Regulation, Regulation (EC) No 141/2000
The European Commission introduced the Paediatric Regulation in 2006 to improve the health of children. This ensures that medicines for children are of high quality, ethically researched, and authorised appropriately. You need to submit paediatric investigation plans (PIPs) and paediatric studies under this regulation.