Tuesday, October, 15, 2019 05:57:56

Safety concerns have necessitated the requirement of more granular drug information and data transparency, a factor that vividly exhibits the growth scope of pharmacovigilance market. Pharmaceutical giants have been scrupulously planning to deploy advanced PV capabilities in order to provide a resource-intensive, transaction focused, and less reactionary drugs. Many companies are also shifting their focus to alternate delivery models, in a bid to increase efficiency and capacity. This range varies from internal redesigning to full-scale PV outsourcing. Not to mention a strict regulatory framework speaks volume and has much to contribute in the overall pharmacovigilance market share.

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Pharmacovigilance market size was valued at USD 3.9 billion in 2017 and is expected to witness growth of around 10.7% CAGR from 2018 to 2024.In the face of the growing complexity in pharmaceutical domain, pharmacovigilance (PV) market stands to garner much popularity over the ensuing years, on virtue of its incredible potential to ensure drug safety. The procedure though being utilized fundamentally since many years, the stringency in safety documentation for drug approvals brought about recently have somehow aided pharmacovigilance industry to establish its stance as an individual niche vertical. The determinant behind it can be the ongoing chain of unfortunate events with regards to adverse drug reactions. This, in consequence, has made drug safety as one of the top issues for healthcare regulators.

A concise insight into the regulatory landscape of pharmacovigilance market:

  • The Pharmacovigilance Risk Assessment Committee of European Medicines Agency has recently recommended new measures to avoid valproate exposure of babies during pregnancy. Reportedly, the committee has mandated that the packaging of all valproate medicines should include a visual warning about the associated risk in pregnancy. For pharmacovigilance market players, this is a vital pointer to be taken into consideration.
  • In what can be touted as an attempt to proliferate regional pharmacovigilance market, the Indian Pharmacopoeia Commission recently announced its plan of organizing a series of workshops at Ahmedabad and Mumbai. As per experts’ opinion, with this sensitization of regional pharmacovigilance industry stakeholders, regulators would be prompted to implement stringent regulatory norms on pharmacovigilance.

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  • FDA was authorized to oversee the amendments related to pharmaceutical domain, by virtue of which pharmacovigilance market also comes under the jurisdiction of FDA. The entity imposes post-marketing controls on medicinal products to monitor manufacturing facilities after approval has been granted. Allegedly, the objective is to confirm ongoing compliance with both previously approved requirements, legislation and notifications.

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