Introduction The COVID-19 pandemic and changes in legal frameworks have sparked and accelerated the major trend of digitalization in the health sector. This trend is expected to result in merging digital products, including medicinal products and medical devices, into a digital ecosystem supported by shorter development cycles and technological progress. Digitalization is expected to improve […]
Digital Future of Healthcare Read More »
Technological disruptors are gradually revolutionizing various aspects of life sciences and healthcare. Software is slowly becoming an important part of products and are being integrated into digital platforms for medical and non-medical purposes. There are 3 types of software-related medical devices: 1) Software as a medical device (SaMD), 2) software in a medical device, and
Regulatory Guidelines for Software and Artificial Intelligence as a Medical Device Read More »
Introduction Malaria is one of the biggest and most pressing tropical and infectious diseases that pose a significant threat to public health- particularly children. In 2019, a study analysis found that malaria caused 643,000 deaths globally with children <5 years of age living in Africa and exhibiting the highest disease burden [1]. According to the
WHO Pre-qualification pathway: advancing access to vaccines Read More »
The European Medicines Agency (EMA) has created a sustainable network called DARWIN EU, which aims to generate real-world evidence to support regulatory decision-making in the European Union. This coordination centre network uses data analysis techniques and real-world interrogation methods to extract information and insights from various data sources, including structured and unstructured sources. Its main
DARWIN EU – Generating Real-World Evidence to Support Regulatory Decisions Read More »
In 1992 the US FDA established the accelerated approval pathway for drug development as treatment options for serious or life-threatening conditions like cancer based on the effect the drug has on surrogate measures or an intermediate clinical end-point that could predict the real endpoint. However, these investigational drugs are subjected to post-approval confirmatory studies which
Benefits of randomized control trials in accelerated approvals for oncology therapeutics Read More »
Overview Medical Device manufacturers must demonstrate the safety, efficacy, and quality, of the product and that it functions as intended without endangering the user or patient. The European Medicines Agency (EMA) mandated a clinical evaluation report (CER) that is required to obtain a CE marking for devices that are to be marketed within the European
Medical Devices – Considerations for preparing a Clinical Evaluation Report (CER) Read More »
The European regulatory system constitutes a network of pharmaceutical regulators from the European Economic Area (EEA), the European Medicines Agency (EMA), and the European Commission (EC). In addition to ensure that patients have timely access to safe, efficacious and high quality medicines, it is responsible for establishing a regulatory environment that keeps up with innovation.
EU regulatory strategic goals for human medicines Read More »
A crucial part of pharmacovigilance (PV) and post-market drug safety surveillance are unsolicited adverse event (AE) reports from various stakeholders including patients, pharmaceutical organizations, and healthcare professionals. These are spontaneous reports and serve as important sources of safety information for a product. Regulatory agencies rely on spontaneous reports for post-market safety surveillance from which they
Social & Digital Media Sources in Drug Safety Read More »
Successful biosimilar approval is determined by how well biosimilarity can be demonstrated between the proposed product and its innovator product. An analytical biosimilarity study provides the technical data that would confirm the similarity of critical quality attributes (CQAs) of the proposed product to its innovator in terms of safety, efficacy, and potency. This constitutes comprehensive
An overview on the analytical assessment techniques for biosimilar development Read More »
Regulations surrounding biosimilar development are based on how well the similarity between the proposed molecule and the reference product (RP) can be demonstrated. Indeed, there is a need for increased access to cost-effective treatment for various conditions, which drives biosimilar development. Regulatory agencies such as the US Food and Drug Administration (FDA) and the European
Differences in the regulatory pathways for biosimilar development: EU vs USA Read More »
