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 »
The pharmaceutical industry including its operations and associated functions run on data and content. Whether it is safety, regulatory, or clinical data, the pharmaceutical industry and all its stakeholders are actively involved in collecting, monitoring, evaluating, and exchanging crucial information. Indeed, the need for standardization of medicinal product information was highlighted in order to facilitate
Maintaining compliance with Identification of Medicinal Products (IDMP) standards Read More »
The development of biologic products has increased over the last few years in order to treat complex and serious conditions. These biologics, or innovator products, are approaching the end of their exclusivity period which warrants for the development of biosimilars to support timely access to alternative and more affordable treatment options for patients in need.
Biosimilars uptake – An upward trend Read More »
Combination products are an integral part of healthcare as they provide innovative treatment options for complex diseases. They can be as simple as a first aid kit with vials & syringes or as complex as antibody-drug conjugates combined with drugs [1]. More often the development of combination products helps to enhance the function of an
Combination products: a regulatory perspective Read More »
The regulatory landscape for combination products has been somewhat of a “question-mark” for manufacturers for various reasons. This is because when drugs, devices, and/or biologics get combined to produce a combination product, there is uncertainty on which regulatory requirements will apply to the components of the product and the product as a whole. Furthermore, the
Pre-market pathways for combination products Read More »
The onset of the pandemic amplified an already growing concern in the European Union (EU)- the shortage of medicines, equipment, and devices that subsequently burdens the health system and puts patients at risk. Some of the reasons for these kinds of shortages are related to problems in manufacturing that can delay production, shortages of raw
Mitigating medical device shortages in public health emergencies Read More »
IntroductionHereditary angioedema (HAE) is considered a rare, autosomal dominant disease that is characterized by repeated episodes of swelling which can occur on the face, limbs and even the gastrointestinal and respiratory tracts leading to severe pain, vomiting, and asphyxiation. These swelling attacks may occur unexpectedly and can significantly affect a patient’s quality of life (QoL).
Access to Orphan Drugs in Hereditary Angioedema Read More »
Technology is rapidly driving the growth of the Pharmaceutical and Life Sciences industries. With digital solutions being made more easily available, drug development & pharmacovigilance are transforming to become more efficient, compliant, and patient safety focused. However, regulatory affairs is still somewhat manual where processes and tasks are repetitive, siloed, and resource-heavy. Though Life Sciences
Digitalization in Regulatory Affairs Read More »
