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 »
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 …
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 in humans to treat, prevent, or even diagnosis conditions that are associated with high treatment burden [1]. However, regulations surrounding CTGTPs vary per region as …
Convergence of regulatory frameworks surrounding cell, tissue, and gene therapy products Read More »
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 industry being one of them. From the delays along the drug development pipeline, to non-compliance products in the market being at risk, the industry faces …
The impact of the Russia-Ukraine war on clinical trials Read More »
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 scrutiny, compliance costs, development of artificial intelligence, evolution of data science and increasing demands regarding cost-effective compliance solutions. With ever changing regulatory requirements, pharmaceutical organizations …
DDReg’s RegTech space: your regulatory solution for achieving rapid market access Read More »
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 (EU), the European Medicines Agency (EMA) is responsible for product approval. The EMA was the first regulatory authority to establish a regulatory framework for biosimilars …
Biologics development & regulatory approval – EMA perspective Read More »
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 treatment of life-threatening conditions. With an aging population and a growing demand for treating chronic conditions, biologic use is on the rise. However, they are …
Biosimilarity and Interchangeability in the MENA region Read More »
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 $5 billion to $8 billion. Multinational organizations seeking their entrance into emerging markets of the world focus on the biologic-treatment rates of countries and are …
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 regulate medical products. It appeared like AMA will become a reality now that 15 African Union Member States have ratified the Treaty in recent months. …
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 it. When the ICH guideline paper Pharmaceutical Quality System: Q10 was published in 2008, it highlighted knowledge management as a major enabler of a pharmaceutical …
Knowledge Management in Regulatory Affairs (KMRA) Read More »
