Medical devices will be banned in clinical trials
The European Medicines Agency (EMA) has banned therapeutic communication devices, including contact lenses, in clinical studies for the second time in a decade, in a move designed to prevent the spread of disease.
The move comes after the EMA’s Advisory Committee on Medicines and Healthcare Products (ACMH) recommended that contact lenses should not be used in clinical settings and patients must receive a vaccine.
The EMA says the decision is an important step in reducing the spread and improving safety of new treatments, such as those to treat severe depression and Parkinson’s disease.
In recent years, the use of contact lenses has grown in Europe and elsewhere due to concerns about eye and ear infections and a lack of effective therapies.
In October, the EU’s Food and Consumer Agency (EFSA) banned the use and sale of contact lens contact lenses in Europe.
The European Commission has also proposed changes to the law on the marketing of new medicines to ensure patients can be protected from unnecessary medical treatments.
The latest move comes ahead of a meeting on Thursday in Brussels between the European Commission and the Council of Europe, which are working to agree a new set of guidelines for medicines and medical devices.
The EU’s Health and Consumer Safety Committee (ECHCC) is expected to vote on the guidelines on Tuesday, but the EHCC has until the end of November to give its consent.
Last week, the European Medicine Agency (EMEA) approved two new types of contact lenses, which can be worn on the upper eyelid.
The devices are designed to give a patient an improved view of their surroundings, but also provide an enhanced view of the world around them.
The devices are expected to be introduced in clinical trial programmes for the treatment of Parkinson’s, the flu, and HIV.
Doctors and pharmacists have already been given a chance to use them in clinical experiments and the EMEA’s advisory committee recommends that contact lense use should be discouraged until further clinical research has shown its effectiveness.
The new devices have a maximum effective dose of 400 milligrams per square centimetre, and a maximum therapeutic dose of about 3,000 milligrammes per square metre.
The EMEE said that it would be possible to give doses up to about 2,000mg of the medication to patients with severe depression or Parkinson’s Disease.