• Manoj Swaminathan

Regional or Harmonized Pharmacovigilance - the Way Forward!

Updated: Jul 26

Just Imagine! What if we had one set of Pharmacovigilance Guideline(s) for all the SAARC (South Asian Association for Regional Cooperation) Countries! Whenever we think of regional or harmonized Pharmacovigilance, the first thing that comes to our mind is the 'European Medicines Agency,' where we have a standard set of Pharmacovigilance Guidelines (GVP) for over 30 countries.

The actual number of countries is much higher, as numerous other countries have adopted the GVP Guidelines. Harmonization makes life easy for both the regulatory agencies as well as the Marketing Authorization Holders (MAH) Harmonization has the following advantages:

  1. Standard Requirements (including QPPV)

  2. Unified Reporting Timelines

  3. Centralized Database for Reporting Adverse Events

  4. Work-Sharing Procedures for Regulatory Agencies

  5. Significant Cost Savings and Win-Win Situation for all!

  6. Lesser Number of Inspections to be conducted, etc.

Although the Good Pharmacovigilance Practice Guidelines came into effect on 02-Jul-2012 in EU/EEA, it took about 64 months for 'almost' complete harmonization. The term 'almost' has been used because we still have country-specific requirements in EU/EEA, and the local QPPV requirement is one of these. Apart from EU/EEA, more countries have tried to harmonize and form regional guidelines. These include the following:

  1. Arab

  2. Eurasian Economic Union

  3. PAHO

The GVP for Arab League presently includes 22 countries, that include the following countries. This guideline is in place since 2014. However, harmonization is still in process, and country-specific Pharmacovigilance requirements continue to exist. Algeria,

  1. Bahrain,

  2. Comoros,

  3. Djibouti,

  4. Egypt,

  5. Iraq,

  6. Jordan,

  7. Kuwait,

  8. Lebanon,

  9. Libya,

  10. Mauritania,

  11. Morocco,

  12. Oman,

  13. Palestine,

  14. Qatar,

  15. Saudi Arabia,

  16. Somalia,

  17. Sudan,

  18. Syria,

  19. Tunisia,

  20. the United Arab Emirates,

  21. Yemen

Eurasian Economic Union includes countries such as Armenia, Belarus, Kyrgyzstan, Kazakhstan, and Russia. Again, harmonization is in process, as country-specific Pharmacovigilance requirements continue to exist.

PAHO: This includes countries such as Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Haiti, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Suriname, Uruguay, and Venezuela. The PAHO GVP Document became effective in June 2011. However, there have been no updates since then, and these countries have also released their Pharmacovigilance guidelines.

It may be prudent to state that harmonization is invaluable for Pharmacovigilance, although sustainability may remain a concern. The present time is when countries are realizing the importance of patient safety and working on developing their Pharmacovigilance guidelines.

Given the fact that all countries/ regional systems ultimately report into the WHO-UMC database, harmonization may be achievable. Developing countries should come together and establish unified Pharmacovigilance systems, in the interest of Public Health!