Marketing Authorisation (MA) is the process by which a pharmaceutical company obtains regulatory approval to bring a new product to market. Two main types of MA exist: Centralised and Localised.
Centralised MA is the process by which a single application is made to the European Medicines Agency (EMA) for approval of a product across all European Union (EU) member states. This process is typically used for innovative and complex products, such as biologics, and requires significant resources and expertise.
On the other hand, Localised MA involves submitting separate applications for approval to individual national regulatory authorities within the EU. This approach is typically used for more straightforward products, such as generic medicines, and is often faster and less expensive than centralised MA.
The choice between Centralised and Localised MA will depend on the type of product, the target market, and the resources available to the pharmaceutical company. Both approaches have their advantages and disadvantages, and a comprehensive assessment of the product, market, and regulatory requirements is necessary to determine the best approach.
At every stage of the MA process, it is essential to have a qualified person (QP) overseeing the quality of the product and ensuring that all regulatory requirements are met.
Contact us today on email@example.com to learn more about how we can help you bring your product to market through a Centralised or Localised MA.