On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
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.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017