Post & Pre Marketing Pharmacovigilance in Asia by 2020: Solvay Pharmaceuticals
Dr. Rashmi Hegde, Solvay Pharmaceuticals’ Director Pharmacovigilance Asia-Middle East-Australia-Canada expects to see “mature post-marketing regulations and acceptable regulations with respect to pre-marketing PV” and “PV regulations to be strictly enforced” in Asia by the year 2020.
Dr. Hegde made these comments to Pharma IQ’s Divya Sangam in an exclusive interview, where she discussed the unique challenges to pharmacovigilance in Asia, and the need for immediate action to create a harmonised, and more comprehensive pharmacovigilance network in the region.
Pharma IQ: What are the unique risks and challenges to pharmacovigilance and drug safety faced by pharmaceutical companies in Asia?
R Hegde: Pharma companies in Asia have to deal with the challenges of regulations that are vastly different from those in the Western nations. Often the timelines are stringent and the information required is more detailed. This means pharma companies need new in-house processes for regulatory compliance in the Asian countries. Additionally, there is variation in interpretation of regulations and there is a significant requirement for training of their employees and health care
professionals in the area of drug safety. The novelty of drug safety as a science and an enforceable regulatory requirement is an additional challenge faced by pharma companies.
Pharma IQ: What kinds of solutions will be applicable to address the above mentioned challenges?
R Hegde: These different challenges can be overcome by intensive and repeated training to their employees as well as multiple forum discussions between the different stakeholders such as pharma companies, regulators, health care professionals and perhaps patient support groups.
Pharma IQ: How long do you think it will take to create a harmonised regulatory system in Asia, and what challenges do you foresee in creating an EMEA equivalent in Asia?
R. Hegde: At this point in time, it seems as though harmonisation is not yet on the horizon. One of the positive factors in this area is the networking that we see between the different regulators. We know that regulatory agencies from the Western countries are now talking to their counterparts in Asia, and also offering guidance and support in relation to GMP and drug safety.
Pharma IQ: What steps can pharmaceutical companies and regulatory authorities take to create a comprehensive pharmacovigilance system to serve the safety of Asian patients?
R Hegde: Open and varied discussions between these two stakeholders as well as sharing of their strengths in the area of drug safety will be a major step to create a comprehensive PV system tailored to the safety of Asian patients.
Pharma IQ: What can be done to combat drug counterfeiting and to minimise the impact of substandard pharmaceuticals on drug safety and pharmacovigilance in Asia?
R Hegde: Regulations, vigilance and education! Technical advances such as computerisation, radio frequency identification and mapping of products would help to reduce successful counterfeiting. In addition, the education of patients on drug counterfeits would also help minimise the menace of substandard pharmaceuticals!
Pharma IQ: Where do you see pharmacovigilance in Asia by the year 2020?
R Hegde: We expect to see mature post-marketing regulations and acceptable regulations with respect to pre-marketing PV. We may expect PV regulations in Asian countries to be strictly enforced in the coming years. Also, we expect a certain level of harmonisation of PV regulations in the different Asian countries through the work of organisations such as ASEAN.