An Insiders Guide to Gaining Product Approvals Across EMEA
Having drugs approved by EMEA regulatory bodies is an essential part of providing safe and effective medicines to patients in the region. Let’s find out just how it is done.
Before a medicine gets to market, a national or regional regulatory body must authorize it. There are several different registration routes a company that manufactures drugs for humans can take to get its products approved within Europe, Middle East & Africa. These include:
- A centralized authorization procedure
- A decentralized authorization procedure
- A mutual recognition procedure
- National authorization procedures
The type of medicine for which the company is seeking approval, determines the registration route a company uses within the EU.
Centralized authorization procedure – an EU single market authorization
The centralized authorization procedure results in a single marketing authorization that is valid in all EU countries including Iceland, Liechtenstein and Norway.
The centralized procedure is required for the following types of medicines:
- Human medicines for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases;
- All biologic agents or other products made using high-technology procedures such as genetic engineering;
- Advanced-therapy medicines such as gene-therapy, somatic cell-therapy or tissue-engineered medicines;
- Products officially designated as ‘orphan medicines’, which are used to treat rare human diseases.
Companies that want to manufacture medicines not falling under the above categories can also apply for a centralized marketing authorization if the medicine concerned is a significant therapeutic, scientific or technical innovation, or if its authorization would be in the interest of public health.
Centralized procedure applications are submitted directly to EMA (European Medicines Association). Their scientific committee can take up to 210 days to evaluate the medicine, at the end of which time the committee issues an opinion recommending whether the medicine should be approved or not.
The opinion is issued by CHMP; EMA’s Committee for Medicinal Products for Human Use
It is then transferred to the European Commission for adoption. As soon as a Marketing Authorization has been granted, the MAH (Marketing Authorization Holder) can make the medicine available to patients and healthcare professionals in all EU countries.
Decentralized procedure – another route for gaining approval of a medicine
Companies may apply for simultaneous authorization in more than one EU country if a medicine has not yet been authorized in any EU Member country and if it does not fall within EMA’s mandatory scope for the centralized procedure.
Mutual recognition procedure – transferrable authorizations from other EU countries
Companies that have a medicine authorized in one EU Member country may apply for this authorization to be recognized in other EU countries.
National authorization procedure – often used for countries outside the EU
In addition to the procedures outlined above, a national authorization process also exists for EU Member States and EMEA countries outside the EU. The national authorization procedure is rarely used within the EU today, but it is the most common way for non-EU countries to grant approvals. For more information about these procedures it’s best to go to the respective country’s national medicine authority.