Regulatory

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 »

As per FDA’s pre-requisites for Abbreviated New Drug Application (ANDA) filings, applicants should be able to demonstrate their product’s sameness or similarity to its innovator product or Reference Product (RP). All the data generated by applicants on generic versions should be equivalent or the same as that for reference listed drug (RLD). The CDER recently …

US FDA draft guidance: Sameness Evaluations in an ANDA for active ingredients Read More »

The pharmaceutical regulatory landscape in the UK has experienced many changes since Brexit. Several guidelines have been updated for more UK-specific pharmaceutical product regulation. Among these includes the ‘Guidance on the licensing of biosimilar products’ that was first published on the 6th of May 2021 with the aim to outline clear requirements for biosimilar product …

A summary of the “Guidance on the licensing of biosimilar products”- UK MHRA Read More »

The regulatory landscape is consistently evolving as it faces ever-changing guidelines and regulations. On one hand, these patient-centric regulatory changes ensure that safe, efficacious, and high-quality pharmaceutical products reach the market. On the other hand, key stakeholders in the pharmaceutical regulatory environment face significant obstacles. Needless to say, these regulatory challenges are not limited to …

An overview on some key regulatory challenges in API manufacturing Read More »

A biosimilar medicine is one that demonstrates high similarity to another biological medicinal product that has already been approved- this is also known as the ‘reference product’. Interchangeability refers to using one medicinal product instead of another provided the therapeutic intent is the same. In this context, interchangeability is the medicinal product being substituted by …

European Medicines Agency: Biosimilar medicines can be interchanged Read More »

According to the World Health Organization (WHO), cardiovascular diseases (CVD) are the leading cause of death around the world. In 2019, nearly one-third of all global deaths were attributed to CVD-related death; 85% were as a result of stroke and heart attack (1). Over the last few decades, cardiovascular devices have emerged as an important …

Overview on Cardiovascular Medical Device Regulation by the FDA Read More »