RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 2020 > 1 > EMA Consults on GMP Reflection Paper

EMA Consults on GMP Reflection Paper

Posted 22 January 2020 | By Michael Mezher 

EMA Consults on GMP Reflection Paper

The European Medicines Agency (EMA) this week released a draft reflection paper for consultation outlining the good manufacturing practice (GMP) responsibilities applicable to marketing authorization holders (MAHs) under European Commission (EC) GMP guidelines and other EU legislation.
The aim of the 31-page reflection paper is to clarify the myriad GMP responsibilities for MAHs, which EMA admits “can, in some cases, be difficult to comprehend when reading the GMP guide or the applicable legislation.”
EMA points out that while many MAHs “are not directly engaged in the manufacture of medicinal products themselves,” many EU GMP provisions apply to MAHs, such as product quality review evaluations and marketing authorization applicants.
“It should be noted that, as indicated in Annex 16 of the GMP guide, the ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the MAH,” EMA writes.
Specifically, the reflection paper covers the responsibilities and activities that pertain to MAHs under Parts I and II of the GMP guide, as well as many of its annexes, and EU legislation including Directives 2003/94/EC, 92/412/EC, 2001/83/EC and 2001/82/EC. Additionally, the reflection paper also covers aspects of the Falsified Medicines Directive (FMD) and its related delegated regulations, but does not cover some GMP requirements for advanced therapy medicinal products (ATMPs) laid out in Part IV of the GMP guide.
EMA further explains the reflection paper may serve as a reference for competent authorities while conducting inspections of MAHs under Article 111 of Directive 2001/83/EC and Article 80 of Directive 2001/82/EC.
While the reflection paper currently addresses all MAH GMP responsibilities as of the April 2019 update to the GMP guide, EMA says it “should not be taken to provide an exhaustive list” of those responsibilities as the GMP guide is updated over time. Instead, EMA says the reflection paper is meant to cover general GMP responsibilities presented as different themes in Chapter 5 of the document.
Those themes include:
  • Outsourcing and technical agreements
  • Audits and qualification activities
  • Communication with manufacturing sites
  • Product quality reviews
  • Quality defects, complains and product recalls
  • Maintenance of supply of medicinal products
  • Continual improvement activities
In addition to those themes, Chapter 6 of the reflection paper delves into FMD-related responsibilities for MAHs, including requirements for safety features, European Hub-connected repositories, serialization data and decommissioning unique identifiers.
The public consultation on the reflection paper is open through 17 April 2020.


© 2022 Regulatory Affairs Professionals Society.