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 …
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 …
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). …
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 …
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 »
IntroductionThe practice of pharmacovigilance revolves around patient safety by improving the benefit-risk balance of a pharmaceutical product. This is done by alleviating the extent of the adverse reaction associated with it or by enhancing its benefit. Routine minimization measures such as specific dosing regimens, warnings & precautions communication through labeling , patient follow-ups, relevant testing …
Additional Risk Minimization Measures: Pregnancy Prevention Programme Read More »
The Eprex®-pure red cell aplasia case of 1998 engendered the understanding the perhaps the safety associated with biosimilars cannot be extrapolated from the innovator medicine as in the case of generics. Although generics and biosimilars are similar in the manner that they are both permitted for marketing only after expiry of the patent of the …
Pharmacovigilance for Biosimilars vs pharmacovigilance for generics Read More »
The International Conference on Harmonization of Technical Requirements for the registration of pharmaceuticals for human use, or the ICH, was formed to facilitate harmonization of requirements and procedures among member states to ensure safe, efficacious, and high-quality drugs reach the market. The founding regulatory members include the European Commission (EC) of Europe, the Food and …
An overview on pharmacovigilance in Japan, USA, Europe Read More »
