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The formation of the EMA

This month in pharma: July 1993, the formation of the European Medicines Agency (EMA)
calendar July 1993

It's almost impossible now to imagine a time when there wasn't one central organisation to oversee the authorisation of what medicines can and cannot be used in the European Union (EU).

But it was only 19 years ago on July 22, 1993, that the European Agency for the Evaluation of Medicinal Products (EMEA) was formed to analyse the safety and efficacy of drugs and regulate what products were suitable for use in the European market.

Now called simply the European Medicines Agency (EMA), its creation came after a laborious era during which pharma companies ha d to a undergo national review and approval process in each individual EU country, creating a huge duplication of effort.

Initial attempts to change this were implemented in 1975, with the launch of the Committee for Proprietary Medicinal Products (CPMP).

Made up of representatives of regulatory authorities from different European countries, the Committee sought to review the quality, safety and efficacy of products being introduced for marketing authorisation in EU member states.

It wasn't a complete system, however, and the CPMP was not able to authorise what products could then be available and its review could not over-rule the assessment of a country's own regulator.

In an attempt to resolve this, the European Commission launched a mutual recognition process in 1983 that meant a single national review of a pharmaceutical product could then be used as the basis for marketing authorisation by other countries throughout the EU.

It was hoped this would allow a standard method and outcome for product reviews, yet still allow each country's regulatory body to make a final decision on the product's marketing authorisation.

However, national authorities were still not required to accept another country's review, with many choosing to conduct their own rather than accept the assessment of another nation, leading to the continued duplication and time wasting of before.

What was needed was a centralised procedure, with any disputes between countries in their review process to be handed to an over-riding body to make a final decision, ensuring that the authorisation process was a simple and efficient as possible.

And so the EMA was born, with the CPMP (now the Committee for Medicinal Products for Human Use, or CHMP) reviewing any new medicinal products planned for the EU market. This new agency provided the EC with a body with which to grant marketing authorisation across all member states and resolve any national discrepancies.

At its heart were five objectives:

  • To protect public health by mobilising the best scientific resources existing within the EU
  • To promote healthcare through the effective regulation of new pharmaceuticals and better information for users and healthcare professionals
  • To facilitate the free circulation of pharmaceuticals efforts to cultivate a more unified and efficient system within the European single market
  • To support the European pharmaceutical research and development industry by developing efficient, effective and responsive operating procedures
  • To support effort in international cooperation.

Twenty years on these aims remain the agency's core, with drugs approved quicker and across more areas giving patients greater access to medicines and greater encouragement for companies to create innovative products that don't face a mountain of authorisation applications.

Challenges are constantly replaced by new ones, however, and the old issue of national authorisation of a product's safety and efficacy seems to have been substituted with the need to prove a drug is worth the price each country is paying for it.

It's been seen in the establishment of such body's as the UK's National Institute for Health and Clinical Excellence (NICE) and recent changes in France and Germany – similar individualised processes are emerging as the industry's major concern across Europe regarding the launch of new products.

By contrast, the EMA's main aim now is one of streamlining even further, however, with the member state duplication of previous decades continuing but this time on an international scale as the US Food and Drug Administration (FDA), Therapeutic Goods Administration (TGA) of Australia and equivalent bodies in Asia, Canada and elsewhere continue to assess drugs on their own terms.

There are now active and ongoing attempts to combine the efforts of these organisations in the EU, US and Australia at least – although certain differences in philosophy have to be overcome in the process.

As pointed out by Dr Henry Miller in his book To America's Health: A Proposal to Reform the Food and Drug Administration, the EMA is more “client-friendly” than its US counterpart, focusing on monitory product safety and offering advice and information.

By contrast, at least at the time of writing in the late 1990s, he says: “The FDA ... is compliance-orientated, comports itself like a police agency – it actually has armed inspectors – and frequently treats drug companies like adversaries.”

Recent years have seen the two agencies come closer together though, extending agreements to share confidential information, safety records and to take part in joint manufacturing practice inspections (along with the World Health Organisation) all with the aim of improving efficiency in ensuring safety and quality of pharmaceutical products.

The EMA was formed on the basis that it made more sense for industry, governments and patients that European countries work together, and its future is now looking likely to take the ethos international.

Tom Meek
The Author

Tom Meek, web editor at PMLiVE

2nd August 2012


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