Complex generics: Are global regulators addressing the needs? ...
The development of generic versions of innovator medicines is a global public health need.
Poor-quality medical products are all too common in Africa, where substandard and falsified medicines kill nearly 500,000 people each year, according to the United Nations. The continent also has the highest prevalence of poor-quality medicines among low- and middle-income countries at 18.7 percent.
In Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC), the national regulating authority for medical products, is prioritizing local production of medicines to ensure a safer supply of quality-assured medical products to protect patients and communities across the country and continent.
India is often referred to as the ‘pharmacy of the world’ and is undeniably the leading manufacturing hub for many of the world’s most essential medicines.
In the U.S. and around the world, quality standards developed by the U.S. Pharmacopeia (USP) support the availability of safe, quality medicines, regulatory efficiencies, and a strong global medicine supply chain.
The COVID-19 pandemic has presented unprecedented challenges around the world, including to national public health systems and the international biopharmaceutical industry.
In Nigeria, mothers frequently deliver their babies at home—only 36 percent deliver at health care facilities. Giving birth without the assistance of trained healthcare providers leaves babies vulnerable to infections, and some can be fatal.
In conversations about the role of quality standards in public health, you might come across the words “compendia” and “compendial.” At USP, terms like “compendial approaches,” “compendial standards,” and “compendial tools” are part of our everyday vocabulary.