GUIDELINE ON GOOD PHARMACOVIGILANCE PRACTICES

       What is Pharmacovigilance? 

• Today, the World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.

• WHO specifies that any newly developed drug must meet three critical conditions prior to approval by its respective regulatory agency: good quality; effectiveness; safety for intended purpose. 

         

        

     Good pharmacovigilance practices:

• New legislation for pharmacovigilance was introduced in July 2012 in European Union in order to support the implementation of new legislation  a set of guidelines for conducting of pharmacovigilance  

• pharmacovigilance in European Union has been developed which is known as Good pharmacovigilance practices 

• They have replaced the previous set of guidelines in volume 9A of the rule Governing Medicinal products in the European Union 

    The objective of  Good pharmacovigilance practices:

• Good pharmacovigilance practice is set up to ease the performance of pharmacovigilance activities within the European Union 

• It applies to Marketing authorization holders in the EU, European Medicines Agency [EMA], and Medicines regulatory authorities in EU Member states

• Good pharmacovigilance practice covers Medicines authorized centrally via Agency and Medicines authorized at the national level 

      Stucture of Good pharmacovigilance practices :

• Good pharmacovigilance practices Guidelines are categorized into 2 types

1. Modules covering major pharmacovigilance processes 

2. Product or population-specific considerations 

Each chapter and revisions are developed by a team consisting of experts from EMA and from EU Member 

Good pharmacovigilance modules 

Module  Ⅰ: Pharmacovigilance system and their quality system

Module  Ⅱ: Pharmacovigilance system master file [Rev.2]

Module  Ⅲ: Pharmacovigilance inspections

Module  Ⅳ: Pharmacovigilance audits [Rev.1]

Module  Ⅴ: Risk Management Systems [Rev2]

Module Ⅵ: Collection, Management, and submission of reports of suspected adverse reactions to medicinal products

Module  Ⅶ: Periodic safety update report

Module Ⅷ: Post-authorization safety studies 

Module  Ⅸ :Signal management 

Module  Ⅹ: Additional monitoring 

Module  ⅩⅥ: Risk minimization measures

 This Module of GVP addresses the legal requirements detailed in Directive 2001/83/EC [DIR] and Regulation (EC) No 726/2004 [REG], which are applicable to competent authorities in the Member States, marketing authorization holders and the Agency as regards the collection, data management and submission of individual reports of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorized in the European Union (EU).   

The guidance provided in this Module does not address the collection, management, and submission of individual reports of events or patterns of use, which do not result in suspected adverse reactions (e.g. asymptomatic overdose, abuse, misuse or medication error) and which are not required to be submitted as individual case safety reports (ICSRs). This information may however need to be collected and presented in periodic safety update reports for the interpretation of safety data or for the benefit-risk evaluation of medicinal products. With regard to this, the guidance provided in GVP Module VII applies. 

                

Maintenance and further development of GVP 

• Proposals for correction revision or addition of guidance or new GVP Chapters  any member of the EU Regulatory network and any stakeholders can send via mentioned  link 

     htttp://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/landing/ask_ema_landing_page.jspmid.

• All approvals will be reviewed regularly and prioritize with in the governance by  Legislency and National competent authorities 

REFERENCES: 

1. https://www.thefdagroup.com/blog/good-pharmacovigilance-practices-gvp-a-quick-guide
2. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-  pharmacovigilance-practices 
3. https://www.gov.uk/guidance/good-pharmacovigilance-practice-gpvp 
4. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports_en.pdf 
5.  https://who-umc.org/media/164038/the-good-pharmacovigilance-practice-for-arab-countries-v3-12-2015.pdf 
6. https://www.qvigilance.com/blog/tag/gvp 

 

Name Gunda Ramya

Student ID: 204/1222

Qualification: B. Pharmacy

Email: gunderamyareddy123@gmail.com