Records management and archiving in the pharmaceutical industry and regulatory authorities

ABSTRACT

This article describes the processes that take place in the pharmaceutical regulatory environment and documentation on medicinal products. Granting of marketing authorization and other regulatory processes use dossiers on medicinal products as their primary resources. The pharmaceutical industry moved from paper to digital marketing authorization dossiers. The article discusses the tasks of those responsible for managing documentation in the pharmaceutical industry and regulatory agencies. There are people with various job roles who work on the dossiers on medicinal products in the companies and agencies, but they are primarily focused on the content. In most pharmaceutical and regulatory organizations, medicinal products dossiers must be kept for the long term or permanently. Hence, records managers and archivists are most welcome to work in this milieu. In this respect, the article outlines the competencies necessary for managing digital records and dossiers on medicinal products. Finally, the article explores future trends in archiving pharmaceutical documentation and proposes necessary standards and mechanisms for the task, as well as the information model of submission and archival information packages for this domain.

KEYWORDS:

• Digital archives
• dossiers on medicinal products
• electronic common technical document
• pharmaceutical industry
• regulatory agencies

Notes

1. Please see the 2010 study of the eCTD implementation (supported by the European Medicines Agency), in Suchanek and Ostermann, “Electronic Common Technical Document” (eCTD): An International Pro/Con Analysis of the Pharmaceutical Product Electronic Submission Process, 124.

2. Regulation (EC) No 726/2004 §8 and annexe.

3. Iglesias-Lopez et. al., Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States, 2.

4. European Commission, Health and Food Safety DG. Notice to Applicants, 10.

5. Rajh, Sudić and Gvozdanović, “OPeN” — The National Adverse Reactions Database in the Croatian eHealth System, 144.

6. Lowe, “Pharmaceutical Applications” in the European Union: a Guide through the Registration Maze, 76–78.

7. ICH, “The CTD Triangle,” https://admin.ich.org/sites/default/files/2019-05/CTD_triangle.pdf.

8. As listed on the website: https://www.ich.org/page/mission. Regarding the term ‘registration’ — “registration” and “marketing authorization” are taken as synonyms here. Still, in some legislations and regulatory practices, the term ‘registration’ is used for traditional herbal medicines and, partially, homoeopathic medicines.

9. For the implementation status please see ICH Multidisciplinary Guidelines, https://ich.org.ich01.nine.ch/page/multidisciplinary-guidelines#8-1, section M8 eCTD v.3.2.2. Electronic Common Technical Document.

10. Confirmed by the Customer Service Centre representative (MHRA) via email on 24 June 2020.

11. Electronic Common Technical Document (eCTD) v.4.0 EU Module 1 Implementation Guide, 8–9.

12. Best Archiving Practice Guidance, June 2013.

13. Rajh and Simundza-Perojevic, Lessons Learned from Implemented Internal and External Digitization Processes at the Croatian Agency for Medicinal Products and Medical Devices, 198.

14. Smallwood, Information Governance, loc. 223.

15. Smallwood. Information governance: concepts, strategies, and best practices, 333.

16. Giaretta, Advanced Digital Preservation, 305.

17. Deegan and Tanner, Digital Preservation, 162.

18. ISO 14,721:2012, Figure 2–3; ISO 20,652:2006, Figure A-5.

19. See the webpage of DILCIS Board with specifications listed, https://dilcis.eu/. The stated correspondence refers to information packages and METS, PREMIS, and EAD metadata XML files.

20. ISO 20,652:2006, Figure 2–1.

21. For more information please see web page of PTAB Ltd.

22. “Problem-Oriented Assessments” in Archives Management and an Extensive Archival Maturity Model Design, 139–140, 144–145.

Additional information

Notes on contributors

Arian Rajh

Arian Rajh, born in 1980 in Zagreb, Croatia, holds a PhD in archival science since 2010. He is the Head of document, records, and project management department at the Croatian Agency for Medicinal Products and Medical Devices. In 2012 the University of Zagreb, where he teaches archival science courses, appointed him an assistant professor, and in 2018 promoted him to associate professor. His work is focused on case management systems, review applications, enterprise content management systems, archives management systems, and digital archives. He also participated in creating organizational procedures and strategies, international guidelines related to archiving in the pharmaceutical domain, and national archival ordinances, in a group assembled by the Croatian Ministry of Culture.