The centre for drug evaluation and research (CDER) is responsible for ensuring availability of safe and effective medicines in the country. CDER is thus entrusted with the responsibility of the public health. CDER is an important office under the United States Food and Drug Administration. The USA drug approval process for the pharmaceutical products includes a…

The development of drugs is a long process, and it takes 12-15 years to complete the development for regulatory submission. Thereafter, the regulatory approval, licensing, price negotiations etc. take another 2-3 years. Thus, the availability of medicines in the marketplace and its access to the patients is a long wait.  For certain health conditions and/…

Conducting clinical trials is a multifaceted activity involving several stakeholders and participants. Once the trial is finalized, the entire clinical supply chain services process gets activated. The entire process of clinical trial sourcing, producing, packaging, distributing, and managing requires meticulous planning and is referred to as "streamlining the clinical trial supply chain."…

The European Union has established a centralised regulatory authority responsible for authorising new medicines within Europe for human and veterinary use.  The European Medicines Agency (EMA) is the main authority that apart from new drug approvals coordinates with the regulatory authorities of the other member state countries of the EU as well as acts as…

The term "quality assurance" (QA) refers to a wide notion that encompasses all the critical steps in the production of pharmaceuticals. Quality Assurance ensures that the systems and processes used in production of a healthcare product guarantees <<product quality>>.  It is a system for monitoring product quality and process performance that aids businesses in maintaining…

The statement "Reducing Pharmacy Waste: Proper Medication Storage" describes a series of methods and techniques used in pharmacies to reduce drug waste through appropriate storage practices. The objective is to minimize the environmental impact associated with the disposal of unused or expired medications while ensuring that pharmaceutical products are safe, effective, and viable for as…

Drug development is a long, complex, and costly process, often taking 12–15 years to bring a new medicine to the market. The challenge grows when companies aim to introduce the drug in multiple countries. Each nation has its own regulations and requirements, forcing pharmaceutical companies to adapt their development and registration processes for every market—a…

Certain pharmaceutical products require specific temperature control for storage and transportation and to be maintained until administered to the patients.  They are classified as cool chain) requires temperature control between 2-8 deg Celsius) and Cold chain products requiring temperatures below 0 degrees. These products are temperature sensitive and need strict controls to maintain their usability.…

The pharmaceutical industry is one of the world’s fastest-growing and most influential sectors, playing a critical role in advancing healthcare, improving patient outcomes, and driving medical innovation. From developing life-saving medicines to supporting global clinical trials, pharmaceutical companies contribute significantly to modern healthcare systems. According to industry estimates, the global pharmaceutical market is valued at…

Clinical trials are a much-specialised area and an important aspect of drug development. It is very intricate and involves several stakeholders and diverse factors that contribute to its study management and timelines. Clinical trials are a long-drawn process and to be successful it must meet its objective in the planned timelines. Thus, the entire process requires…