Breaking Down the Latest EMA GVP Module Updates (2020-2025)

Indian service provider companies and small and mid-sized pharma companies are eyeing the EU market to provide their services or to sell their drugs. For them, the clock is ticking due to changes in pharmacovigilance guidelines over the past five years. The European Medicines Agency (EMA) is one of the main drivers that sets legally binding guidelines for marketing authorisation holders (MAHs), regulators, and service providers across Europe through Good Pharmacovigilance Practices (GVP) modules. GVP is widely regarded as the leading standard in PV. From 2020 to 2025, the EMA has made significant revisions across several core modules. This has led to the transformation of the adverse event reporting system, emphasizing the necessity of safeguarding patient privacy in accordance with GDPR and enhancing the efficacy of risk mitigation strategies.

What challenges do Indian companies face?

Indian companies often face challenges from shifts in GVP frameworks and receive regulatory feedback and inspection findings. Some of the reasons are:

1. Knowledge gap: Most of the PV officers in India don’t have access to EMA workshops or EU-QPPVs. They receive delayed updates filtered through multiple layers.
2. Resource gap: Most of the companies have limited resources and are engaged in multiple PV activities, such as case processing, aggregate reports, and signal detection in limited time.
3. System inertia: SOPs are written mainly for inspection purposes. These are left untouched until the next inspection cycle, which may cause inconsistent or incorrect procedural execution.
4. Over-reliance on CDSCO without proactive alignment: Companies rely on CDSCO to echo EMA before making structural changes.
5. Under-investment in Quality Management System (QMS): QPPVs are mostly under-resourced with tight budgets.
6. Compliance risk: Missing a GVP update can result in regulatory observations during inspection, delayed product approvals, or even recalls, and a negative impact on trust.
7. Fragmented outsourcing: Most of the companies rely on multiple CROs for PV activities. Gaps in data integrity, reporting standards, and training frequently result from the lack of harmony between them.

The root cause of these is tightening PV regulation and measures introduced by EMA to check compliance.

Amendment Summary: EU GVP 2020-2025

The key updates in GVP modules between 2020 and 2025 include:

• Data Privacy & Reporting Systems

Module VI Addendum II – Masking of personal data in ICSRs (2025): Masking of the report’s personal information, including medical record number, and unmasking them in urgent cases (EMA 2025, Module VI).

Module VII Explanatory note (2021): To prepare and evaluate PSURs under the single assessment (PSUSA). It also highlights real challenges encountered during the two years of running the PSUSA process. This will serve as the basis for an update in GVP Module VII (EMA 2021).

• Post-Autorisation Safety Studies & Risk Planning

Module VIII, PASS Submission, addendum 1: (2020): (Non-Interventional PASS Studies): Mandatory registration and submission of the protocol and final study report to EMA and PRAC are required for category 1 and 2 PASS. Category 3 PASS follows national procedures; for centrally authorised products, the study protocol is submitted with the RMP.

Final GVP Annex III: Other Pharmacovigilance guidance: COVID-19

The pharmacovigilance plan, including RMP and PSUR, ensures the maintenance of transparency and constant monitoring of medicine for COVID-19 even after the end of the COVID-19 era in May 2023 (EMA 2020, EMA transparency).

• Risk minimisation and effectiveness

Module XVI: Risk minimisation measures

Rev 3 – Risk minimisation measures (2024): Measures to minimize the risk by healthcare professionals or the patients using routine tools such as the Summary of Product Characteristics (SmPC)/PI and additional tools such as education material/controlled distribution or restricted access program. Planning, design, distribution, review, collaboration, use of digital technology, and inclusion of PSUR effectiveness (EMA 2024, Rev 3).

Addendum II – Evaluating RMM effectiveness (2024): Evaluate the RMM effectiveness using mixed methods, i.e., quantitative + qualitative, including surveys, patient-reported outcome measures, and patient-reported evaluation measures (EMA 2024).

Addendum I – Minimising embryo-foetal risks of medicine(2025): The evaluation of risk involves reporting it and reducing it through various means such as counselling, pregnancy tests, and steps to take if exposure occurs (EMA 2025).

• Signal management & monitoring

Signal management (Module IX)

Question and answer on signal management, Implementing Regulation (EU) 2025/1466: Amendment of Regulation (EU) No 520/2012 and Conclusion of the Signal Detection in EudraVigilance Pilot by MAHs (2021-2025): Monitoring EudraVigilance data, along with an explanation of the procedure, is mandatory for all MAHs with medicines in the EEA. The pilot project of standalone signal notification forms to EMA/NCAs has been deleted.

Additional Monitoring (Module X) 

This has not been revised. However, the update in safety communication (Module XV) and digital transparency measures has an indirect impact.

• Communication & guidance

Final GVP Annex III: Other Pharmacovigilance guidance

Safety Communication (Module XV): Tailored scientific advice to support step-by-step development of new biosimilars (2024): This includes the eligibility for application. The submission of the application via the IRIS platform includes a list of documents in the briefing package, outlines the follow-up procedure, and specifies the fee for scientific advice.

Annex I: GVP-Definitions (Rev. 5) (2024): Clarification and addition of multiple definitions, such as disease registry and target population (risk minimisation measure)

Beyond GVP Modules: Key Takeaways from IR 2025/1466

In addition to updates to EMA’s GVP guidance on 22 July 2025, the European Commission adopted Implementing Regulation (EU) 2025/1466, which amends IR No 520/2012 to clarify the frameworks around the Pharmacovigilance System Master File, PSURs, PASS, audits, EudraVigilance monitoring, signal management, and terminology and standards. The primary objectives are to strengthen safety by implementing an improved signal management system, increase transparency in subcontracting, and align with global standards. Additionally, the standardized documentation enhances efficacy. It became effective on 12 August 2025, and its full scope of application was introduced on 12 February 2026.

Q. What is the impact of these changes on various stakeholders?

Global Pharma companies:

Increase in budget for compliance, resources, educational material; more reliance on AI tools for case processing and signal detection; expectation from vendor increases

Indian CRO/Start-up/SMEs:

For Indian companies, challenges are inevitable and mentioned above, but this also brings new opportunities.

Opportunity:

Provide assistance to EU clients by offering cost-effective solutions and a specialized team for areas such as PASS study, pharmacovigilance (PV), data management, biostatistics, regulatory affairs, medical writing, and quality assurance. India can also support the center to provide facilities for the Non-Interventional PASS study. It can also help by providing collaborative research networks and help in RMMs and effectiveness checks.

How Our Start-Up helps

We’re creating lean, future-proof systems to help Indian companies pass EMA scrutiny.

Pharmacovigilance services are designedto meet global and Indian requirements.

SOP writing: Writing SOPs that can be updated quickly.

Medical writing: including RMP, PSUR, safety communication, protocols, CSRs, IBs, and non-interventional PASS studies.

Training and oversight: We provide training for your team using real-world simulation of EU audits.

References

1. 1. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev 3) [Internet]. 2020 Jun 24 [cited 2025 Sep 7]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-viii-addendum-i-requirements-and-recommendations-submission-information-non-interventional-post-authorisation-safety-studies-rev-3_en.pdf [Accessed 7 Sep. 2025]. [Accessed 7 Sep. 2025].
   2. European Medicines Agency. Explanatory Note to GVP Module VII: Periodic Safety Report [Internet]. Amsterdam: European Medicines Agency; 2021 Apr 19 [cited 2025 Sep 7]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vii-periodic-safety-report-explanatory-note_en.pdf [Accessed 7 Sep. 2025].
   3. European Medicines Agency, 2024. Questions and answers on tailored scientific advice to support step-by-step development of new biosimilars. [online] Amsterdam: European Medicines Agency. Available at: https://www.ema.europa.eu/en/documents/other/questions-answers-tailored-scientific-advice-support-step-step-development-new-biosimilars_en.pdf [Accessed 7 Sep. 2025]. [Accessed 7 Sep. 2025].
   4. European Medicines Agency. Consideration on core requirements for RMPs of COVID-19 vaccines [Internet]. Amsterdam: European Medicines Agency; 2022 Sep 1 [cited 2025 Sep 7]. Available from: https://www.ema.europa.eu/en/documents/other/consideration-core-requirements-rmps-covid-19-vaccines_en.pdf
   5. European Medicines Agency. Transparency: exceptional measures for COVID-19 medicines [Internet]. Amsterdam: European Medicines Agency; 2025 Jun 29 [cited 2025 Sep 7]. Available from: https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/transparency-exceptional-measures-covid-19-medicines [Accessed 7 Sep. 2025].
   6. European Medicines Agency. Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines [Internet]. Amsterdam: European Medicines Agency; 2020 Nov 12 [cited 2025 Sep 7]. Available from: https://www.ema.europa.eu/en/documents/other/pharmacovigilance-plan-eu-regulatory-network-covid-19-vaccines_en.pdf [Accessed 7 Sep. 2025].
   7. European Medicines Agency. Search results for “Safety Communication” [Internet]. Amsterdam: European Medicines Agency; [cited 2025 Sep 07]. Available from: https://www.ema.europa.eu/search?keywords=anyword&search_api_fulltext=Safety%20Communication&f%5B0%5D=ema_search_categories%3A83&f%5B1%5D=ema_search_categories=004&f%5B2%5D=ema_search_entity_is_document
   8. European Medicines Agency. Guidelines on good pharmacovigilance practices (GVP) – Introductory cover note, last updated with final Addendum I to Module XVI on minimising embryo-foetal risks of medicines [Internet]. Amsterdam: European Medicines Agency; 2025 Aug 28 [cited 2025 Sep 7]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guidelines-good-pharmacovigilance-practices-gvp-introductory-cover-note-last-updated-final-addendum-i-module-xvi-minimising-embryo-fetal-risks-medicines_en.pdf
   9. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures (Rev 3) [Internet]. Amsterdam: European Medicines Agency; 2024 Jul 26 [cited 2025 Sep 07]. Available from: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-xvi-risk-minimisation-measures-rev-3_en.pdf
   10. European Medicines Agency. Guideline on good pharmacovigilance practices – Annex I Definitions (Rev 5) [Internet]. Amsterdam: European Medicines Agency; 2024 Jul 26 [cited 2025 Sep 07]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-annex-i-definitions-rev-5_en.pdf
   11. European Medicines Agency. Tailored scientific advice to support step-by-step development of new biosimilars [Internet]. Amsterdam: European Medicines Agency; 2024 Jun 10 [cited 2025 Sep 07]. Available from: https://www.ema.europa.eu/en/documents/other/questions-answers-tailored-scientific-advice-support-step-step-development-new-biosimilars_en.pdf

• European Commission. Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025 amending Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC. Official Journal of the European Union. 2025 Jul 23;L 1466.