UK MHRA SIMPLIFIES ADVERSE EVENT REPORTING IN CHILDREN
The MHRA conducted a recent workshop with paediatric specialists, healthcare professionals and patient organisations, to assess ADR reporting in children. The workshop concluded that ADR reporting in children was "impractical for busy healthcare professionals and potentially acted as a barrier to reporting".
As a consequence, the MHRA guidance for healthcare professionals reporting ADR in children has been simplified to bring them into line with reporting guidelines for adults. Healthcare professionals must now report all suspected ADRs that are serious, medically significant or result in harm, but need not report less serious or minor ADRs. Healthcare professionals must continue to report all reactions associated with newer medicinal products identified with the black triangle symbol (▼).
This guidance applies to medicinal products, vaccines, herbal or complementary products, whether self-medicated or prescribed, and includes suspected ADRs associated with misuse and unlicensed medicines.
The MHRA hopes that the new guidelines will simplify and speed up the ADR reporting process for children.
On 26 September 2016, a new EU-US collaboration between the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) was announced. This new collaboration is ...06 October 2016
On 1 September 2016, the European Medicines Agency ("EMA") opened for public consultation a Draft revision to its Guideline on the assessment of clinical safety and efficacy in the...08 September 2016