All medicines undergo extensive clinical trials to ensure their safety and efficacy and this data is rigorously examined by regulators before the medicine can be launched.
The safety of medicines is monitored closely after launch, and their benefit to risk balance is carefully assessed by both the pharmaceutical industry and regulators throughout the time they are on the market. If any issues emerge with a medicine, updates to the warnings contained in a medicine information leaflet can be made, or in the rare occasion where a safety issue is considered serious enough, the product can be withdrawn.
In order to have the best possible data for this on-going monitoring process, we would strongly encourage both patients and healthcare professionals to use the MHRA yellow card scheme to report medicine side effects.
On some occasions it may not be appropriate to prescribe some medicines during pregnancy or caution may be needed when prescribing for women of child bearing age. This information will be displayed in the leaflet that comes with the medicine. Doctors are free to decide on the appropriateness of a prescription for an individual patient.
Novel technology such as the MHRA Clinical Practice Research Datalink could further improve medicine safety monitoring, particularly in groups of people which have special considerations such as pregnant women or children.
ABPI Press OfficeTel: +44 (0) 20 7747 1410 or +44 (0) 20 7747 1441Mobile: +44 (0) 7850 312064Email: [email protected]
The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. Our members supply 90 per cent of all medicines used by the NHS, and are researching and developing over two-thirds of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.