Regulation & Policy

The European Medicines Agency has taken the first step towards implementing new European-wide procedures for testing medicines in children.

A new European guideline outlining how companies and regulators can identify and mitigate risks associated with the first studies in humans of novel medicinal products is due to take effect on 1 September 2007.

The UK government has decided to change its 50-year old system for indirectly setting the price of drugs sold to the National Health Service (NHS).

A joint committee of the UK Parliament is supporting the creation and use of hybrid, human-animal embryos for research provided they are destroyed within 14 days after fertilisation and they are not implanted in a womb, according to the committee’s chairman, Phil Willis, the Liberal Democrat MP for Harrogate and Knaresborough.

Over the past 19 months, some 272 small enterprises have approached the European Medicines Agency (EMEA) to ask for assistance in carrying out their development and registration programmes, according to new figures from the agency.

The European Commission is asking scientists, industrialists and members of the public to help it draft a code of conduct for nanotechnology.

The European Medicines Agency has called for the withdrawal from the European market of the neuroleptic, veralipride, following reports of severe side effects.

Five medicinal products, including a generic version of olanzapine, have been recommended for licensing in Europe by the main scientific committee of the European Medicines Agency (EMEA). At the same time, a proposed treatment for Crohn’s disease from Elan Pharma, was turned back.

From 7 July 2007, pharmaceutical companies holding European Community marketing authorisations could be fined at up to 5% of their Community turnover if they infringe their licensing obligations or give false information to the European Medicines Agency (EMEA).

The European Medicines Agency and the US Food and Drug Administration have agreed to exchange information from companies about their proposed studies of paediatric medicines in order to avoid unnecessary trials involving children.