The Agency operates a range of regulatory systems which aim to ensure that:
- The design and conduct of clinical trials for medicines and medical devices provide acceptable levels of protection for participants.
- 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).
- 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.
- 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about a product’s benefits and/or risks, or about the quality of manufacture or supply, it will, if appropriate, be withdrawn or have its use restricted.
- 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.
- 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.
- 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.
- 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.
- The supporting information for professionals and the public about a medicine or medical device is appropriate, readable and fit for purpose.
- Advertising or marketing claims for medicines are justified and targeted at appropriate audiences.
- Pharmaceutical companies and device manufacturers meet their legal obligations in respect of medicines and medical devices.
- 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.
- 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.
