Pharmaceutical Regulatory Affairs: Open Access

In Europe there are very high expectations regarding the quality, safety, and efficacy of medical devices. But in reality, it fails, due to many scandals that threatened the lives of thousands of people. So, the EU has introduced the new regulations in medical devices to meet the expectations. The old directives such as medical device directive (MDD) and active implantable medical device directive (AIMDD) are now replaced with medical device regulation (MDR), and in vitro diagnostic medical device directive (IVDD) is replaced with in vitro diagnostic regulation (IVDR). When compared to MDR there are more significant changes introduced in the IVDR. The New Regulations has a hard deadline for certifications and manufacturers cannot launch their product without certification, hence manufacturers have to meet the new regulations within the given time frame. The change in regulation brings a disturbance for the medical device industry. The manufacturers have to make strategic decisions to streamline their innovation pipeline and R&D processes in response to the increased cost of compliance and longer product certification time, so it is essential to conduct the SWOT analysis to evaluate the effect of new regulations. To bridge the gap between the new and old regulations, Gap analysis should be done. Gap analysis is used as a tool that helps to monitor the quality management system and is mainly useful where Standards and regulations are updated. This analysis may add value to reforming the portfolio. The regulatory authorities have to focus on the problems faced by manufacturers and try to resolve the issues as soon as possible.

The emergence of the novel coronavirus (COVID-19) has demonstrated the challenge of a single infection to health systems across the globe. The World Health Organization (WHO) declared COVID-19 as a pandemic on 11^th March 2020, pointing at the time to the over 118,000 cases of the coronavirus illness in over 110 countries around the world and the sustained risk of further global spread. Congruent to this declaration by the WHO, countries were expected to accelerate their individual efforts amidst striking the right balance between protecting healths and preventing economic or social disruption. In response to the pandemic, regulatory authorities of food and drugs in various countries are also recognizing the new demands and obligations that the pandemic has brought and taking measures to meet them and provide the much-needed support. The Ghana Food and Drugs Authority (FDA) has taken various accelerated actions to meet the local demands in managing COVID-19. The regulatory interventions not only aim to facilitate the authorization of medicines and health technologies, sensitize the public on disease prevention and ensure the uninterrupted availability of medical and food supplies but also seek to inspire and boost local industrial potential in line with the President’s challenge to expand domestic capability and self-reliance. The Ghana FDA’s efforts are multifaceted and include propping the Drug Supply Chain, expeditious testing of essential COVID-19 medicines, facilitating efforts at COVID-19 test kit evaluation, active post market surveillance and public sensitization on preventive measures. The outcomes of the FDA response have informed ample opportunities that can be leveraged on now and beyond the pandemic and sensitized the Authority on the need to simulate possible emergencies and be better prepared in future happenings.