In the pharmaceutical industry, ensuring the safety and efficacy of drugs doesn't end with Regulatory approval. Post-market surveillance emerges as a pivotal phase in public health. This blog explores its critical role and the Regulatory compliance measures that pharmaceutical companies must adopt in the post-approval stage.
COVID-19 caused major disruption in Pharmacovigilance (PV) efforts, particularly post-marketing surveillance. Due to the pandemic's rapidly increasing volume of data and shifting Regulatory and consumer trends, PV leaders were forced to rethink their traditional safety data management processes and PV technology to bring unprecedented levels of scalability, reliability, and agility to their workflow. PV has been on the front lines of this pandemic since its inception, assisting clients in researching COVID treatments and vaccines.
The establishment of European Union Medical Devices Regulations (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/746 posed additional requirements. The significant aspect highlighted was implementing the Post-Market Surveillance system (PMS). Enabling PMS will ensure the devices' safety even after being launched in the market.
Medsafe, aka the New Zealand Medicines and Medical Devices Safety Authority, undertakes the regulation of therapeutic products in New Zealand. The Agency is a business unit of the Ministry of Health. It follows several legislations for regulating therapeutic products, the major ones being the Medicines Act of 1981 and Medicines Regulations. ‘Therapeutic purpose’ is described in the Medicines Act as the treatment, diagnosis, and prevention of disease or the modification of physiological activity.
Implementing and maintaining a Quality Management System (QMS) is mandatory to launch medical devices in the global markets. Having an effective QMS should embody all the procedures and processes covering all aspects from design to production, packaging and distribution. It must become a continuous pursuit for every medical device organization to update their QMS, as per the directives set forth by the global Regulatory Agencies.