Why are the industries regulated?


Regulatory Affairs is a sector born out of the need of governments across the globe to ensure the development and the delivery of safe and effective products to consumers and individuals in areas such as pharmaceuticals, medicines, medical devices, agrochemicals and cosmetics. 

The first to be regulated were the healthcare industries, with the diphteria epidemic leading to the 1902 Biologics Control Act in the United States, which regulated the sale of viruses, serums, toxins and similar products in the District of Columbia. Though initially dominated by the US, due to its technological forefront and market size, nowadays health ministries worldwide implemented directives, acts and regulations to control the safety of products, by making sure manufacturers comply with the minimum safety criteria established beforehand.

In Europe, the European Union started to harmonize the regulation of healthcare products in its member states in 1980, with the New Approach Directive to become the first major breakthrough in healthcare regulation in the region.

In Japan, the first regulation on production of non-regulated patent medicines (regulation of face lotions, toothpaste etc. not deemed to be patent medicines) or quasi-drugs was published in 1900. In 1960, the current Pharmaceutical Affairs Act was validated and the obligation to appoint a technical officer for cosmetics was installed. Seven years later, cosmetic quality standards and cosmetic ingredient standards were established.

Cosmetic products are subject to regulatory requirements in almost every country. In a century of constant innovation and rapid technological development, Health Ministries across the globe are continuously reviewing and updating laws, in order to ensure a high degree of consumer protection, while also helping minimize business impacts such as loss of sales, product recall or withdrawal.



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