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MHRA/EMEA: rivalry or partnership?

How medicines are authorised for sale and by whom

Although the Medicines and Healthcare products Regulatory Agency and the European Medicines Agency (EMEA) do the work, neither of them grants licences.

The MHRA is the competent authority of the UK. It liaises with all the devolved Governments and advises the UK licensing authority.

The EMEA co-ordinates the formation of opinions by the Committee for Human Medicinal products and passes these opinions to the European Commission.

Even then, the opinion has to pass through a committee of administrators drawn from the member states’ health ministries before it can become an EC licensing decision.

Medicines licensing in Europe operates at a number of levels with different regulatory agencies being responsible for different types of marketing authorisation.

The vast majority of marketing authorisations (product licences) are granted at a national, rather than at European, level, but with increasing harmonisation across EU member states.

Currently, there are about 400 EU-wide licences, compared with 22,000 UK licences. But, increasingly, national licences, such as those issued in the UK by the Medicines and Healthcare products Regulatory Agency, are the same as those issued by other national regulators.

This is because the EU operates a mutual recognition system intended to allow products to move unhindered between national markets.

The whole system is designed to lead to licensing by consensus, and disagreements between member states on safety issues are rare. Nevertheless, there is a procedure — rarely used — where votes are taken and the majority view has to be accepted by all involved.

“We have the right to withdraw or suspend a licence nationally,” said Maggie Jackman, of the MHRA’s European policy team. “But we have to notify the European Commission within 24 hours. Then negotiations take place through the scientific committees to try to get EU-wide agreement on a single action.”

Finally, any disagreement can be referred to the European Standing Committee on Medicinal products for Human Use, which can decide the matter by majority vote. But even here, most differences are resolved by agreement.

Conversely, the European Medicines Agency (EMEA) cannot act unilaterally. Instead, it has to be asked to act by either a national regulator, the company that markets a product or by the EC. An EMEA spokeswoman said: “Normally, if a product is referred to us it is because there are serious differences between the member states or there are serious public health concerns.

An example of how this works is the handling of cyclo-oxygenase-2 inhibitors a couple of years ago. One product had a centralised European licence, while all the others were nationally licensed. The EMEA was only able to consider all the drugs involved as a group because it was asked to do so. Otherwise, it would only have been able to look into the product with a European licence. Even then, it was only asked to devise an opinion on the risk of cardiovascular and skin reactions and so had to restrict itself to that.

The spokeswoman said: “National products have to be referred to us by the EC or by a member state. We can’t initiate. But if this happens, then any resulting opinion becomes binding on all member states.”

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Europe

The number of such referalls that are being made is rising sharply. In 2004, just five opinions were reached after referral, with six being completed in 2005. But, in 2006, 32 opinions were finalised and the number currently under consideration is described as “large”.

Even so, the EMEA has no scientific assessors of its own and relies on outsourcing its requirements to the various national licensing authorities around the EU.

Miss Jackman said: “All the work on agreeing the terms on which products are licensed, including the work that’s done by the EMEA to produce a European licence, is done on the basis of discussion between scientists from all the member states.”

This means that even when the MHRA wants to change the terms of a licence issued nationally, under the mutual recognition procedure, or a company asks for a national licence to be amended, the relevant national licences are changed in all EU countries at the same time.

“Very little work that we do now is purely national work. It’s usually got some sort of dimension that involves other member states,” Miss Jackman said.

Monitoring the safety of medicines remains a national responsibility, although data are pooled centrally for those medicines with European licences and there is also a European database populated with nationally derived safety reports.

The MHRA clearly plays a leading role in the entire European licensing system — both EU-wide licences and national licences — because it is the lead regulator on seven in every 10 products, whether they are to be licensed by mutual recognition of national licences or through the decentralised procedure for simultaneous licensing in all countries in which a manufacturer wants to sell the product.

Citation: The Pharmaceutical Journal URI: 10004834

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