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Registration procedures for generic drugs in the EU

In the EU there are several different routes to marketing authorisation for generic drugs.

Centralised Procedure

Marketing authorisation is issued by the EMA and is valid for the entire EU/European Economic Area.

This procedure is optional for generics:

  • if the reference product is authorised via a centralised procedure (CP)
  • if a CP is in the interests of patients at a EU level.

Quality control for generic drugs


Generic medicines manufacturers must comply with the strict rules of good manufacturing practice (GMP). This ensures that all medicines—generic and originator alike—are produced consistently and controlled to stringent standards of quality in accordance with current legislation.

Generic drugs – registration, quality, value and sustainability

In the current climate of economic downturn and with the impending ‘patent cliff’ threatening many major pharmaceutical companies, generic medicines are increasingly looking like a good option.

Generic applications in the EU, patents and exclusivity

Types of protection on the originator molecule that have to be taken into account by generic drug manufacturers when filing applications for generic drugs in the EU include the following:

  • patents at the time of marketing
  • supplementary protection certificates at the time of marketing
  • data/regulatory exclusivity at the time of regulatory submission
  • market exclusivity at the time of marketing.

Big Pharma and the generics industry

What with growth in the global pharmaceutical market slowing and even stabilising and the impending ‘patent cliff’ looming, Big Pharma needs to look for other options.

Impact of healthcare reforms

Even though global pharmaceutical market growth has stabilised, it still means a rising medicines bill. The global pharmaceutical market is expected to add nearly US$300 billion through 2014, topping US$1.1 trillion [1].

The growth in the generics industry

During 2010 there was unprecedented activity in the pricing and market access landscape, much of which has aided the growth in the generics industry during 2010. This activity occurred across three broad themes:

Patent cliff and the generics industry

An estimated US$186 billion in sales revenues of patent-protected medicines is likely to be exposed to generic competition between now and 2016 [1].

A sustainable generics industry in the EU

Today, generic medicines play an essential role in treating disease by increasing the accessibility and affordability of modern day pharmaceuticals. It is therefore essential to ensure that generics can enter the market as soon as possible after patent and data exclusivity protections expire and compete effectively in order to maintain a sustainable generics industry.

Generics grab 80% share of US market and fill 78% of prescriptions

As more brand-name drugs lose patent protection, use of less expensive generics continues to rise. A new report, published in April 2011 by IMS Health, shows a slowdown in US spending on drugs, but an increase in the percentage of prescriptions filled by generics and a faster rate of capture of market share by generics after patent expiry.