Efforts to globally harmonise Pharmacovigilance (PV) regulations have been on-going for more than two decades. To what extent is this realistically achievable and, ultimately, is this in the best interest of patient safety?
By some accounts, there are thousands of APIs currently on the market. Compounded with exponential population growth, the information deluge on the heels of social media, and upcoming significant changes to the drug safety framework in Europe, it would seem sensible to expect that a global framework for monitoring the safety of products would allow Regulators to more consistently monitor pharmaceutical product safety in the populations that they are responsible for protecting. China's SFDA has held consultations with FDA and EMA to further understand the drug safety system in the Western industrialised nations, and Japanese companies are beginning to globally integrate their PV systems. But, Nostrapharmus asks, would global harmonisation of regulations really make pharmaceutical products safer for the public?
Certainly, standardisation of the structure of safety information, including the product name itself, would help ensure that safety information is more consistently captured, transferable, and readily aggregated for analysis. By July in Europe, as part of the most significant drug safety changes in 15 years, marketing authorisation holders (MAHs) will be required to submit product information to the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) using a message format designed to align with the international standard, ISO IDMP by 2015. It is expected that individual case safety reports (ICSRs) will need to be submitted referencing this product dictionary by that time. Along with this, the ICSR itself is moving toward an ISO standard with an expectation of E2B (R3) HL7 sign-off by International Conference on Harmonisation (ICH) later this year.
Standardisation of timelines for processing safety information also makes sense, for example, 15 calendar days from first awareness for serious events - the goal being to share information as expeditiously as reasonably possible. To some degree there is already harmonisation happening here at the MAH level, since some design their processes to the lowest common denominator. Enforcement of post-marketing commitments would also seem natural as these are conditions of the approval agreed with the Regulator.
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