Life sciences glossary A–B

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • Life sciences glossary A–B
  • Accelerated assessment
  • Accelerated Access Review
  • Active implantable medical device (AIMD)
  • Active device (or active medical device)
  • Active Pharmaceutical Ingredient (API)
  • Active substance
  • Active Substance Master File (ASMF) procedure
  • Advanced therapy medicinal product (ATMP)
  • Adverse event
  • More...

Life sciences glossary A–B

IP COMPLETION DAY: 11pm (GMT) on 31 December 2020 marks the end of the Brexit transition/implementation period entered into following the UK’s withdrawal from the EU. At this point in time (referred to in UK law as ‘IP completion day’), key transitional arrangements come to an end and significant changes begin to take effect across the UK’s legal regime. This document contains guidance on subjects impacted by these changes. Before continuing your research, see Practice Note: What does IP completion day mean for Life Sciences?

C–D | E–H | I–N | O–P | Q–U.

Accelerated assessment

The accelerated assessment procedure reduces the timeframe for the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) to review a marketing authorisation application from 210 to 150 evaluation days. Applications may be eligible for accelerated assessment if the CHMP decides the product is of major interest for public health and therapeutic innovation.

See also marketing authorisation.

Accelerated Access Review

The Accelerated Access Review, commissioned by the UK government, recommends the creation of a new accelerated access partnership to speed up and simplify the process for getting the most promising new treatments and diagnostics safely from pre-clinical development to patients.

Active implantable medical device (AIMD)

Directive 90/385/EEC, the Active Implantable Medical Devices Directive, which was implemented in the UK by the Medical Devices Regulations 2002 (MDRs 2002), SI 2002/618, defines this

Related documents:

Popular documents