Most life sciences organizations find it difficult to streamline their Regulatory submissions process due to frequent changes in the submission guidelines. According to a recent analysis conducted by the United States Food and Drug Administration (USFDA), 32% of submissions with study data had critical data conformance issues. The process necessitates an extensive understanding of collaboration among internal and external stakeholders.
On February 09, 2022, the European Medicines Agency (EMA) commenced the establishment of a Coordination Centre for Data Analysis and Real-World Integration Network (DARWIN EU®). It is the first step towards integrating Real-World Evidence (RWE) into assessing medicines across the European Union (EU). Ensuring the safety and efficacy of medicines is the prime activity of any Regulatory Agency, and RWE is proving to be a reliable source for gathering real-time evidence from global health care databases.
Emergency Use Authorizations (EUAs) are significant in making life-saving medicinal products available to patients faster. They have been helpful in dealing with pandemics like COVID-19. An initiative of the United States Food and Drug Administration (USFDA) started in the year 2004, and the EUA came into force when Section 564 of the Federal Food, Drug, and Cosmetic Act was amended by the Project BioShield Act.
Supply chain challenges across the globe have laid bare the inefficiencies of the distribution system framework amidst the pandemic. Considering its enduring impact on the global pharmaceutical market, better operational structure and resilient operational framework are the basis for seamless manufacturing requirements in hindsight. For continents like Africa, ninety-six (96) % of their drug demand is fulfilled by importation, which collectively affects the availability of drugs (Onyango, 2021).
The year 2017 was an eventful year for the Regulatory space, with several major happenings taking place across various industries such as: Pharmaceuticals, Biologics, Cosmetics, Medical Devices (MD) etc. While the MD industry witnessed the strengthening of MD regulations across the EU, the cosmetics industry saw advancements in the form of improved guidelines for cosmetic product safety.
The Life Sciences market is growing and is expected to reach US$ 4,200 Million by the end of 2024. At the same time, the world is turning more protective about increasing health concerns. Alongside addressing the health needs and aligning with the market scenario, the pharma, biotech, cosmetic, medical devices and healthcare organizations shouldn’t only innovate new compliant products, but also ensure that they are accessible across the globe with stringent safety and efficacy measures.