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The European Medicines Agency (EMEA) is a decentralised body of the EU. Its main responsibility is the safety and promotion of public health, through the evaluation and supervision of medicines for human use. The EMEA holds responsibility for the scientific evaluation of applications for European marketing authorisation of medicinal products (1).
NEW GUIDELINES
On 1st February 2009, the EMEA released new guidelines for companies developing medicines for the treatment of Alzheimer’s disease (AD) and other dementias, and for Parkinson’s disease, in the light of recent scientific progression in the understanding of these diseases and conditions (2). The document itself is offered as general guidance on the development of medicinal products for the treatment of dementia and its subtypes. It does not replace other EMEA and ICH guidelines, but rather works in collaboration with them.
The advances over the past few years in both clinical science and molecular biology have contributed to an emphasis on and growing interest in the development of more valuable symptomatic or disease-modifying treatments, such as early treatments that could prevent the emergence or even slow the progression of a disease. These guidelines have been developed to assist companies developing such medicines on appropriate clinical trial designs (2). |
