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
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.
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory...03 January 2017