The COVID-19 pandemic has brought about unprecedented changes in the healthcare industry, including the Pharmacovigilance (PV) process. The pandemic re-emphasized the role of PV in the pharmaceutical industry. As personalized medicine gained popularity, the tactics of pharmaceutical manufacturers and the PV process flow for ensuring the end-user’s safety had to alter. The drug/Medical Devices & Vaccines (MDV) manufacturers faced more challenges as the market transitioned towards personalized medicine, which led to an alignment with new trends and technologies.
When the COVID-19 pandemic was first recognized as a global health crisis in 2020, global Health Authorities (HAs) took innovative steps to deal with it in the best possible manner. Likewise, pharmaceutical companies came up with several vaccines/medicinal products for the benefit of the public. However, registering the products turned out to be quite challenging. To simplify the registration while upkeeping their safety, quality, and efficacy, HAs granted Emergency Use Authorizations (EUAs) to a few vaccines and relevant products.
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.
To note, there are many gaps in the Regulatory science that need to be addressed for the development and evaluation of medicine. Global Regulatory Agencies make strong efforts to close these gaps and enable access to innovative medicines that address the patient’s needs.
For the first time, the EMA issued a list of Regulatory science topics that needed further research to erase the gaps and published it as Regulatory Science Research Needs (RSRN) list. What are those topics? Let’s get to know.
Intending to curb the spread of COVID-19, the MHRA extended the free PPE (Personal Protective Equipment) scheme, which was initially introduced in March 2020. The scheme intends to protect the health and social care providers, and community pharmacies, and public sector organizations from COVID-19, by providing easy access to PPE in the volume required.
Biologicals are booming as therapy and have significantly become an established treatment option to provide ailment to niche disease segments which seemed impossible earlier. COVID-19 pandemic has made researchers keen to develop biosimilar and interchangeable products for the patient population at an affordable price. The procedure to attain a biosimilar and interchangeable status is rigorously structured by the FDA to ensure that the quality of the preparation remains significantly unchanged.
Modern-day research and advancements have changed the dynamics of the life sciences landscape. Governments & Health Authorities are constantly facing new challenges amidst the paradigm shift from the pre-COVID era to the present-day scenario. Such a challenging environment brought about an end-to-end evolution of the industry, from new drug development to supply chain management. Accelerated efforts across COVID-19 vaccine development, deployment and distribution orchestrated a united front against the pandemic.
Regulatory practices across the globe have a significant role in ensuring that the drug preparation/product sourced for a disease is safe for consumption and effective against the targeted ailment. As of the current pandemic situation, Health authorities across the globe are granting emergency use authorizations based on the preliminary data obtained through phase III clinical trials. However, with exponentially increasing demand for vaccines, substandard and falsified vaccine products in circulation have been reported.
Health Canada has clarified its stand on the research use only testing kits related to COVID-19. Health Canada regulates the import and sale of medical devices and IVDs (In-vitro Diagnostic Devices) in the Canadian market. In the event of the ongoing COVID-19 pandemic and to facilitate the supply of essential medical devices and IVDs, Health Canada has released various Interim Orders for the manufacturers, importers and distributors.
Since the onset of Coronavirus Disease 2019 (COVID-19), Health and Human Services (HHS) has declared a Public Health Emergency. The US FDA, since then, has been releasing various enforcement policies to ensure continued supply of certain essential medical devices, which play a vital role in prevention, diagnosis, management and treatment of COVID-19 and associated co-morbidities. A new enforcement policy has been released by the US FDA to facilitate the increased supply of coagulation systems used for assessing the viscoelastic properties of whole blood and the hemostasis in patients.