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GCP: A Question & Answer Reference Guide
common and centrally managed clinical trial application form). The key to a sustainable solution may in part lie
with the emergence of a mature body of experienced inspectors with a sophisticated level of EU-level exchange
and understanding, and a realistic awareness of the realities of GCP standards in action.
Through expert groups such as the GCP Inspectors Working Party, EMA has supported and continues to support
the harmonization efforts. In addition, EMA organizes regularly public workshops where stakeholders are invited
to debate current challenges and evaluate possible remedial actions.
In operational terms, it is most frequently the inspectors who are the arbiters of what is and is not acceptable.
Inspection manuals were already made publicly available in 2007. Furthermore, inspectors from Europe meet
regularly under the auspices of EMA to discuss new trends and development and also to agree on the interpretation
of the rules. Also a continuous exchange of opinions and experience occurs with FDA inspectors. European
inspectors are also actively involved in the training of inspectors from emerging countries and they also actively
participate in initiatives such as CTTI or the OECD working group. Transparency around what represents an
inspection finding and its grading has greatly improved over the years. In recent years the collaboration with ex-EU
inspectorates has greatly increased what drives comparability of inspection approaches and reporting of inspection
outcomes.
Promoting consistency in the implementation and interpretation of the clinical trials directive across the EU
member states remains an important preoccupation of industry. Companies frequently express concern about the
lack of harmonization for applications for clinical trial authorizations as a result of different dossier requirements
and/or application of the law; increased bureaucracy and uncertainty as a result of variable national requirements
placed on industry; and different requirements for safety reporting. There is an industry consensus that the clinical
trials directive fails to achieve harmonization because individual member states continue to impose different
requirements, some of which go beyond those set out in the directive, that are disproportionate with the objective of
protecting safety of trial subjects. This has resulted in different regulatory standards being applied by the member
states in granting clinical trial authorizations, and these differences adversely impact the ability of companies
to initiate and continue to carry out multi-center trials across the EU. The proposed EU clinical trials regulation
proposed by the Commission in 2012 will hopefully address some of the most pressing concerns. In this regard, it
should be noted that the Commission in preparing the draft document has engaged in multiple stakeholder hearings.
20.41 Q. Can the public or other sponsors have access to the rationale leading EMA to the approval of a new
medicinal product?
A. The European Medicines Agency publishes a full scientific assessment report called a European Public
Assessment Report (EPAR) for every medicine granted a central marketing authorization by the European
Commission
(see
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.
jsp&mid=WC0b01ac058001d124).
This key information on medicines authorized for human use, includes a public-friendly summary in questionand-answer format and the package leaflet. In addition, this site also contains information on medicines that have
been refused a marketing authorization or that have been suspended or withdrawn after being approved.
20.42 Q. Is information available from the European Medicines Agency regarding plans and direction for
future GCP inspections and other activities?
A. Each year, the EMA publishes a work plan for the GCP inspection group. The Good Clinical Practice Inspectors
Working Group (GCP IWG) was established by the European Medicines Agency (EMA) in 1997, within the scope
of article 57(1)(i) of Regulation (EC) No 726/2004. This group focuses on harmonization and coordination of
GCP related activities at a European level. This document can be found on the EMA web page for public review
describing inspection and guidance plans for the next year (http://www.ema.europa.eu/docs/en_GB/document_
library/Work_programme/2018/03/WC500246333.pdf).
The Work plan for GCP Inspectors Working Group for 2018 (EMA/87812/2018) has been published on 22 March
2018.
The has also published the Procedure for Preparing GCP Inspections requested by the EMEA [sic]: http://www.
ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004455.
pdf
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https://www.ema.europa.eu/en/ema-redirect?redirect_type=jsp&curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124 https://www.ema.europa.eu/en/ema-redirect?redirect_type=jsp&curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124 http://www.ema.europa.eu/docs/en_GB/document_library/Work_programme/2018/03/WC500246333.pdf http://www.ema.europa.eu/docs/en_GB/document_library/Work_programme/2018/03/WC500246333.pdf https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ins-gcp-2-procedure-preparing-gcp-inspections-requested-emea_en.pdf https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ins-gcp-2-procedure-preparing-gcp-inspections-requested-emea_en.pdf https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ins-gcp-2-procedure-preparing-gcp-inspections-requested-emea_en.pdf

Good Clinical Practice: A Question & Answer Reference Guide - 2020/2021

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