Regulatory

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. […]

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

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

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

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 drugs (RLD). The CDER recently issued

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

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

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

Access to contraceptive options for reproductive health helps women in achieving their reproductive goals by allowing them to plan and have safe pregnancies. Spacing pregnancies is beneficial for maternal health and allows women to pursue other priorities such as education or work. In developing countries, maternal morbidity and mortality rates are relatively high and evidence