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 &…

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…

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…

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…

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…

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…

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…

We are exhibiting at DIA Europe 2023 Meet our experts at booth #59 to discuss your queries on market access strategies , Regulatory Intelligence, Regulatory Strategies, Feasibility Studies, Life Cycle…

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…

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…

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…

Overview Pharmacovigilance (PV) and post-market surveillance is important to capture the safety profile of a drug. The entire information on a benefit-risk ratio & safety profile is not known until…

Overview A drug is authorized by an agency only when it demonstrates a positive risk-benefit balance or safety profile for the target population. It is a key component of Pharmacovigilance…

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…

Individual Case Safety Reports (ICSRs) are a key aspect of pharmacovigilance (PV) and post-market safety surveillance as they provide crucial safety information for an approved pharmaceutical product, and a holistic…

A signal is information that arises from single or multiple source/s that may suggest a potential causal association between a drug and event given that the causal relationship between drug…

Structured Product Labeling (SPL) was first introduced in 2006 by the US Food and Drug Administration (FDA) with the aim to enhance the communication of product, quality, and facility information…

Regulatory authorities around the world conduct pharmacovigilance (PV) inspections to verify that marketing authorization holders (MAHs) and allied organizations maintain compliance with PV requirements, obligations, and relevant standards. This applies…

Medico-regulatory writing is an important part of regulatory affairs in the Pharmaceutical and Life Sciences industry. Regulatory standards are becoming more stringent in terms of data requirements as a result…

The integration of artificial intelligence (AI) and machine learning (ML) technology into the pharmaceutical and life sciences industry is demonstrating significant benefits on several fronts. Whether it is incorporation of…

Cell, tissue, or gene therapy products (CTGTPs) can contain non-viable or viable human cells or tissues, viable animal cells or tissues, or recombinant nucleic acids and are intended for use…

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…

The biosimilar market is rapidly growing across the globe as patents and exclusivities for biologic products approach their expiration dates. Indeed, biosimilars offer more access due to their affordability which…

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…

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).…

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 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…

The electronic transfer of regulatory information and subsequent review of drug applications is now more streamlined after decades of paper-based procedures. The electronic version of the Common Technical Document (CTD),…

Electronic regulatory submissions have their roots in the late 1980s and have significantly developed over the last few years, especially in key markets. The migration from paper-based submissions to electronic…

Arthritis is an inflammatory condition that affects people worldwide leading to disabilities and decreasing the quality of life. Rheumatoid Arthritis (RA) is the most prevalent inflammatory arthritis that has triggered…

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…

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…

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…

Adverse event processing & causality assessment is the preferred way to identify a drug product related risk and its association with patient safety. An Individual Case Safety Reports (ICSRs) is…

An important aspect of patient safety is Pharmacovigilance, that is the science and activities relating to the Detection, Assessment, Understanding, and Prevention of adverse effects or any other medicine-related problems.…

Florence Nightingale once said “The very first requirement in a hospital is that it should do the sick no harm” 1 This notion has been evolving ever since to provide…

The European Union (EU) implemented significant changes in the way clinical trials (CTs) are conducted where the EU Clinical Trial Regulation (EU CTR) (Regulation EU 536/2014) came into effect early…

Treating Clostridium difficile infections using biotherapeutics Biotherapeutics are therapies that are essentially based on isolating large molecules of proteins, produced by live organisms, engineered to prevent, treat, and cure various…

Ever since the incorporation, it has been DDReg’s endeavor to provide high quality services to its customers. To achieve this, DDReg has been consistently and regularly working towards improving its…

In a technology driven era where businesses are increasingly incorporating advanced information and data management tools into their operations, the risk of facing cyber attacks and breaches is also increasing.…

Managing regulatory information for a pharmaceutical product along all stages of its life cycle is a key challenge in the pharmaceutical industry. Now, as more opportunity markets emerge bringing their…

The pharmaceutical industry is one that is highly regulated by means of legislations and regulations that bring together administrative, technical, and legal information about a medicinal product. These can be…

Drug laws & regulations in India have roots that are almost 80 years old. India still follows drug laws that were framed in pre-independence time through Drugs & Cosmetics Act…

On Friday 1st July 2022, DDReg Pharma wholeheartedly celebrated its 13th Foundation Day. Employees from the Gurgaon, Mumbai, and Hyderabad offices connected virtually to commemorate not only the grand occasion…

The pharmaceutical industry is one that is constantly growing and simultaneously facing challenges. The onset of the pandemic has brought new obstacles that require immediate attention and innovative solutions. Quality…

Technological disruption is rapidly occurring across all industries. In the pharmaceutical industry, technological contenders are gradually transforming the landscape of drug development, clinical trials, and pre-clinical phases. Indeed, this holds…

In an era of technological advancement, and easy access to such disruptors, pharmaceutical organizations are increasingly looking to outsource their solutions to enhance efficiency and reduce cost. Inevitably, there are…

Drug abuse has gradually become an increasing issue due to the use of non-medical prescription drugs. Thus, pharmacovigilance and drug safety has become an even more crucial aspect for ensuring…

Nanobodies are engineered small proteins that recognize and specifically bind to an antigen to initiate an appropriate signal- like antibodies. However, nanobodies bind to antigens with greater specificity and display…

From pre-clinical phases to post-marketing follow up studies, the drug development process is a challenging, expensive, and time-consuming process that can take many years to complete. Companies spend millions of…

CPhI provides a networking platform for pharmaceutical industry leaders. As America accounts for approximately 40% of global pharmaceutical sales, CPhI North America is the ideal event that encourages pharmaceutical experts…

Drug safety is all about the right patient receiving the right drug at the right time for an improved outcome for each patient. To achieve this, a Qualified Person Responsible…

The Russia-Ukraine war has undoubtedly affected millions of people in and around the world. Several industries have taken a huge hit where operational and business continuity has been threatened, pharmaceutical…

The 7th of April 2022 marked the 74th anniversary of the founding of WHO in 1948 which is celebrated annually as ‘World Health Day’. Each year draws attention to a…

RegTech focuses on technologies that may facilitate the delivery of regulatory requirements more efficiently and effectively than existing capabilities. The global adoption of RegTech is a result of increased regulatory…

The healthcare ecosystem is driven by several factors. Government vision, successful partnerships, modern legislation, and adoption of innovation are some of the most crucial ones from a regulation point of…

Biologic medicinal products, particularly biosimilars, have revolutionized the treatment of chronic conditions. As biologic products lose patent protection, biosimilars emerge as more readily accessible treatment alternatives. In the European Union…

A biological drug (or biologic) is one that is produced from a living organism or contains components of a living organism. They have become indispensable tools in modern medicine, for…

Smart regulatory processes and regulatory intelligence have evolved over past decade. Human race has finally transferred its knowledge and experience to machines for smart processing. Automation of processes, use of…

Over the last five years, biosimilars have progressively gained traction. Global sales are expected to more than double to $15 billion by the early 2020s, with emerging markets accounting for…

In 2019, the African Union’s Bureau of Heads of State and Government approved a new Treaty for the establishment of the African Medicines Agency (AMA) to improve countries’ ability to…

Integral health integrates traditional treatment in a coordinated way with alternative medicine. Multimodal interventions, which combine two or more interventions such as conventional medicine, lifestyle changes, physical rehabilitation, psychotherapy and…

Knowledge management (KM) has been a recognized discipline in other sectors for over 20 years, but it has taken a long time for the biopharmaceutical business to debate and formalize…

The COVID-19 pandemic has forced healthcare systems to drastically and quickly rethink how they offer care. The unusually rapid spread of telehealth has been one of the most astonishing continuing trends.…

With a laser-like emphasis on results and value, healthcare is fast moving to a new world of patient choice. Indeed, healthcare systems that have historically emphasized medical treatments based on…

One of the fastest expanding technologies on the planet at present is Artificial Intelligence (AI). It has been gaining so much popularity lately that even industry and sector have applications…

IDMP is a progression of five specific guidelines established by the International Organization for Standardization (ISO) that emphasize different identification standards in the pharma industry. These standards establish an internationally…

The US Food and Drug Administration (FDA) has recently finalized its guidance to generic drug manufacturers on how to seek drug development information through the controlled correspondence (CC) process. This…

The US generic drug industry has grown into a major component of health care, with generic drugs accounting for the vast majority of retail drug prescriptions dispensed. On August 18,…

The pharmaceutical industry is one of the most important industries that will be directly impacted by Brexit. When the United Kingdom’s referendum was held in June 2016, the majority of…

In July 2018, the European medicines regulatory network became aware of the presence of nitrosamine impurities in an Active Pharmaceutical Ingredient (API). This was the first time that a nitrosamine…