Developments of Pharmacovigilance in Asia

The pharmacovigilance scene in Asia is currently evolving as Asia emerges as the largest player in the pharmaceutical market. With the dynamic activities of clinical trials occurring in China, India and rest of Asia, pharmacovigilance is fast gaining attention. The importance of managing adverse drug events/ adverse drug reactions (ADEs/ ADRs) needs to be recognised and regulated to protect the health and safety of consumers.

Looking back 20 years ago, there were very few countries in Asia with regulated pharmacovigilance systems. Drug safety issues such as withdrawals of vioxx and cisapride, changes in the regulatory requirements by more developed nations like US and EU and growing demands for R&D activities in Asia, have prompted Asian regulators to look into more effective implementation of pharmacovigilance systems.

Pharmacovigilance goes beyond just submission of case reports of suspected adverse effects of medicines. It involves complex processes including the need to monitor the safety of medicines throughout their lifecycle and to manage identified real and potential risks.

Challenges ahead

Pharmacovigilance in Asia has become important public health issue as regulators, drug manufacturers, consumers and healthcare professionals are faced with a number of challenges.

These include the following:

• Cultural variation in medical practices (traditional vs. western)

• Differences in disease and prescribing practices and genetic composition of the population

• Lack of pharmacovigilance experts

• Lack of human and financial resources within the regulatory agencies

• Pharmacovigilance is not seen as a priority in some Asian countries

• Pharmaceutical companies see pharmacovigilance as a cost centre and non-strategic

• No robust pharmacovigilance regulations in many Asian countries

• Technological challenges like databases, web-based reporting etc

• Lack of pharmacovigilance awareness and understanding by healthcare professionals, consumers and general public

• Compliance to adverse effect reporting by generic and traditional medicines manufacturers

• Hesitation of healthcare professionals to report adverse effects due to possible litigation

• No harmonised regulatory requirements

• Drug counterfeits

• Quality of drug manufacturing

• Drug interactions (traditional and western medications)

Finding the right formula

Currently in Asia, on the one hand, some countries have robust pharmacovigilance systems. On the other hand, there are also countries with no systems at all. In between these two extremes are countries having developing systems. Many Asian regulators are in the process of revising their existing regulations. New regulations are also being established.

There is an ongoing collaboration between the East Asia and South East Asia regulators relating to future perspectives, harmonisation and enhancement of drug safety in the region.

Pharmacovigilance in Asia will continue to evolve and improve. This is primarily due to pressing compliance requirements by regulators from developed nations in a bid to protect their consumers and the need to enhance public safety.

The following are some recommendations for regulators to further improve pharmacovigilance in Asia:

• Collaboration with other regulators. WHO can play a leading role in this collaboration and assist countries who do not have a robust PV system in place

• Approach WHO and US FDA for training so as to strengthen the enforcement of pharmacovigilance

• Develop awareness programmes for consumers and healthcare professionals

• Promote the active participation of healthcare professionals

• Rendering financial and technological assistance to develop national pharmacovigilance databases

• Working with drug manufacturers to promote international harmonisation of pharmacovigilance regulations

• Sharing of safety information with other regulators