What kinds of decisions are made about medicines and medical devices?

The Agency operates a range of regulatory systems which aim to ensure that:

1. The design and conduct of clinical trials for medicines and medical devices provide acceptable levels of protection for participants.
   
   
   
2. A new medicine or medical device is allowed on to the market with a licence or CE-mark only if there is enough evidence that the potential benefits will outweigh the likely risks.
   
   CE marking for a device is a claim of compliance with the Essential Requirements of European Directives. It has a similar function to that of a licence – or market authorisation – for a medicine. The two kinds of authorisation are intended to provide assurance that a product’s safety has been assessed before marketing, together with its efficacy (for medicines) or performance (for devices).
   
   
   
3. We receive enough reliable information from healthcare professionals, patients and the public, and companies, about adverse events with medicines and devices that are in use.
   
   
   
4. If new information becomes available about a product’s benefits and/or risks, or about the quality of manufacture or supply, it will, if appropriate, be withdrawn or have its use restricted.
   
   
   
5. If there is new information about an adverse effect of a product that needs communicating to healthcare professionals or the public, we or companies issue advice or warnings with an appropriate degree of urgency and through appropriate channels.
   
   
   
6. Good advice is given to professionals or the public if we become aware that a medicine or medical device is inappropriately or incorrectly used, or is inadequately maintained, sterilised or tested.
   
   
   
7. The availability of a medicine accords with the risks it poses. It could be available for purchase from any shop, available only under the supervision of a pharmacist, or available only with a prescription.
   
   
   
8. The public can have confidence that CE-marked medical devices available over the counter can be used at home without having to be in the hands of a healthcare professional.
   
   
   
9. The supporting information for professionals and the public about a medicine or medical device is appropriate, readable and fit for purpose.
   
   
   
10. Advertising or marketing claims for medicines are justified and targeted at appropriate audiences.
    
    
    
11. Pharmaceutical companies and device manufacturers meet their legal obligations in respect of medicines and medical devices.
    
    
    
12. The supply of unauthorised or counterfeit medicines and medical devices is prevented or at least disrupted, and inappropriate sales of second-hand devices are discouraged.
    
    
    
13. Information in relation to our decisions is made available unless it cannot for legal or other reasons be made public, striking a balance between the need for openness and the need to respect commercially sensitive information.
    

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