en
12.05.2022

Local PV Regulations Worldwide – Finding, Interpreting & Implementation

At iVigee, we strive to provide solutions to our clients which will last forever, leading to a higher standard of patient safety.

Today, let us tap into the world of Pharmacovigilance Regulations. You may call it “Regulatory Intelligence”. And instead of thinking of one or two countries, let’s imagine multiple countries in multiple continents. Use your current organization’s geographic reach to come up with a list of countries. But the key is to have a global perspective.

With a global perspective, or multiple geographic regions in place, it often becomes difficult to meet all local regulatory requirements. Often enough to create a difficult dilemma for many stakeholders who are involved in drug safety aspects of medicinal products.

Examples of PV Regulatory Questions

Below are a few sample regulatory questions:

  • What is the System used by the Competent Authority to support its ICSR database?
  • Must the PSMF package address CAPAs resulting from major/critical findings made during Inspection in specific countries?
  • Are MAHs required to provide in National language the whole PV System Description package?
  • Is the latest PSMF required for a PV Inspection?

The answers may be simple for the countries you or your organization know well.  But for other countries where your organization is less familiar as a MAH…the situation can become tricky and sometimes a guessing game at best. With affiliates or other resources responsible for compliance but not experienced with PV Regulations, the problem can be magnified and create non-compliance.

Major Pharmacovigilance Regulatory Challenges

  • Finding current regulations
    • Apart from language difficulties, finding regulations or uncovering the lack of published regulations is common
      • An example would be in many countries of the world where it is simply not clear what types of penalties exist for Marketing Authorization Holders if compliance rules are violated. Often countries list penalties may apply, but zero details, and with ambiguous regulations to begin with, question marks remain.
  • Interpreting current regulations
    • Proper interpretations of regulations is critical. At iVigee, we have realized that two local PV experts may often come up with very different interpretations of the exact same regulation, and although two interpretations may seem useful, when they conflict you can be stuck.
      • (Take for example if two local regulatory experts disagree on something as simple as the CA’s ICSR reporting email address, as is often the case with some recent audit findings in several developing countries)
    • Another challenge with interpretations involves mixed guidance within a single regulatory authority. You may be surprised, however past experiences has proven via audits and communication with local PV experts globally that two or more different interpretations may exist for one specific regulatory requirement.
  • Implementing Local PV Regulations
    • Taking a discovered and interpreted regulation to the next step of implementation is of course crucial
    • Figuring out exactly what has changed from the past requirement to the current may also be a challenge

Many Challenges, And Many Solutions

PV regulation compliance is a challenge, and fortunately, there are multiple solutions available to both pharmaceutical and biotech companies, as well as for Clinical Research Organizations.

At iVigee, we are very happy to be partnering with the Institute of Pharmacovigilance(iPV), as they are developing and pioneering a new process that we believe will revolutionize Pharmacovigilance Regulatory Intelligence.

iPV is a non-profit organization which is working with not only local PV experts, but also local health authorities and other relevant local stakeholders globally. The end goal is to develop extremely accurate recognized and confirmed regulatory interpretations that can be trusted and put-to-use. With a focus on timeliness and accuracy, the solutions we expect to benefit not only corporations, but health authorities and higher education and many other professionals in the pharmacovigilance industry.

In 2022, there is infinite opportunity to maximize technology’s ability to interconnect all corners of the globe. And in the coming days and months, iVigee along with our partners worldwide expect to uncover some monumental changes to PV Regulatory Intelligence. 

To stay connected on this topic, we encourage you to join our dedicated PV Regulatory Intelligence email list, it is called iViReg. To join – CLICK HERE. You will be the first to know when our new services focused on PV Regulatory Intelligence is available.

Thank you,

iVigee’s iViReg Team

Join our monthly email digest

By submitting you agree to our privacy policy.